359 Clinical Safety jobs in the United States

**12904BR**
**Title:**
Specialist, Clinical Safety
**Job Description:**
Support clinical safety aspects of MicroVention clinical studies. Job duties:
+ Provide all required clinical safety support to assigned clinical studies, including study safety documentation development, adverse events (AE) review, safety investigations, and startup/management of independent safety committees/ adjudicators.
+ Draft, review, and provide input to the clinical safety components of clinical study protocols, study reports, safety manuals, safety CRFs, study supporting materials, and other related documentation.
+ Review and triage study adverse events and prepare for independent physician or committee review by preparing/tabulating these events, gathering relevant source documentation, and preparing narratives.
+ Schedule and manage the proceedings of physician safety committees including Clinical Events Committees (CECs) and Data Safety Monitoring Boards (DSMBs), as well as the activities of independent Clinical Events Adjudicators (CEAs).
+ Support the selection of physician partners, including CEA/CEC/DSMB delegates and other committee members, and provide all required training.
+ Generate and present reports to physician safety committees as well as reports of committee findings and results.
+ Partner with clinical research project managers and Medical Affairs and Safety Manager to ensure safety startup activities and pace of events adjudication aligns with study timeline and milestones and to provide regular progress updates.
+ Support clinical science and regulatory affairs functions by utilizing medical expertise to provide input to study design, clinical evaluation reports, clinical study reports, literature review, risk management, regulatory submissions, questions from regulatory authorities, scientific analyses, and other scientific documentation.
+ Support clinical project management function by utilizing medical expertise to provide input to protocol development, risk/benefit analyses, adverse events review, adverse events reporting, investigator questions, investigator meetings, clinical study reports, and other related documentation/activities.
+ Minimal domestic travel required (1 - 3 trips per year).
+ Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
+ Perform additional duties as assigned.
**Auto req ID:**
12904BR
**Location:**
Aliso Viejo, California, USA
**Department Name:**
650-Clinical Admin-Post Market
**Qualifications:**
1. RN/BSN or equivalent.
2. Minimum one (1) to three (3) years of experience providing clinical safety support to regulated clinical device studies or relevant clinical research experience, academic experience, or experience in a hospital setting.
3. Ability to produce high-quality scientific communications and narratives.
4. Strong written and verbal communication skills.
5. Strong interpersonal skills to build effective relationships with geographically diverse physicians and internal business partners.
6. Strong detail-orientation and organizational/time management skills.
7. Proficiency in standard computer programs including MS Office (Word, Excel, PowerPoint, Outlook, Teams, etc.).
8. Ability to maintain strict confidentiality.
**Desired Qualifications**
1. MD or foreign equivalent.
2. Clinical, academic, CRO, or industry experience in a relevant field (neurology, neuroradiology, or neurosurgery).
3. Knowledge of GCP, FDA, and ICH regulations and guidelines.
4. Knowledge and experience in the detection, understanding, review, investigation, and assessment of adverse events.
5. Class III medical device safety experience.
**External-Facing Title:**
Specialist, Clinical Safety
**Posting Country:**
US - United States
**Salary Range:**
$85,000-$115,000 (Compensation may be higher/lower based on experience, education and skill sets)
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.

For more than 50 years, Trilogy has provided people across Chicago and beyond with support to recover from mental illness and move toward stability. We provide our clients with an array of essential services and ongoing support so that they can live independently and thrive in our community. Trilogy’s mission is to enable people in mental health recovery to build meaningful and independent lives through comprehensive and integrated care. We envision a society where everyone impacted by mental illness is valued, embraced, and supported holistically, systematically, and culturally; where the stigma of mental illness is eliminated; and where quality of care is not determined by socioeconomic status.

$64,000 - 73,600 /Yr.
Schedule: Monday - Friday; 8:00 am - 4:30 pm
Location: Rogers Park
Hybrid Schedule: 3 days in-office; 2 days remote

The Clinical Safety Specialist will assume project implementation and support duties for safety and risk management initiatives. This role will be responsible for managing Trilogy’s incident report response program and will provide compliance monitoring for safety activity across Trilogy sites. This role will support the Emergency Management program by conducting and monitoring disaster drills and supporting the ERT program. This role will provide operational support to clinical risk management program initiatives and will also provide support to the Safety Committee, Critical Incident Reporting Committee, and the Clinical Risk Staffing meetings. This role will assist with training, communication, and improvement projects pertaining to clinical and operational safety and risk management. This specialist will be the go-to staff deployed to address safety/risk issues with clinical teams.

The Clinical Safety Specialist is also responsible for quality assurance and risk management activity involving clinical charting. They will execute internal audits, present trending and summary reports, and make recommendations regarding improvements to processes or results. The Clinical Safety Specialist must demonstrate an aptitude for data management and information systems, and a well-rounded clinical knowledge base. 

Responsibilities

• Provide support and guidance to projects convened by the Safety Committee and projects supporting Trilogy’s annual Risk Management goals.
• Serve as the point person for incident report collection and triage, and guide staff in using Trilogy’s incident reporting software. Lead the triage of safety/risk reports and place them in front of the right people. Initiate and track investigations and follow-up activity.
• Deploy to individual teams/sites as needed to conduct targeted investigations, ensure follow-up on safety/risk-related tasks, or to serve as a subject matter expert on safety and risk management issues. Create back-and-forth communication about high-risk processes and improvement opportunities, and in doing so help maintain a living inventory of safety risks and risk management topics.
• Manage the disaster drill campaign each year. Conduct drills when needed, and ensure that drills are completed on time. Conduct compliance activity so drills can be monitored for quality and effectiveness. Orient new ERTs and maintain the ERT roster.
• Provide coordination and support to the Safety Committee, Critical Incident Report Committee, and Risk Staffing Team.
• Coordinate with Facilities staff to ensure the timely completion of internal and external facility inspections as per CARF and other regulatory requirements. Manage a table of responsibilities for site-based safety activity and ensure that all tasks are completed on time. Work with Facilities leadership to ensure a quarterly report on site-based safety risks for the Safety Committee.
• Collect and analyze internal and external data on safety and risk management and create drafts of actionable reports for the Safety Committee, Critical Incident Reporting Committee, and various levels of Trilogy leadership.
• Participate in CPI training program as a trainer and a program co-lead. Personally conduct other safety-related trainings as needed, whether in-person or virtually. Conduct and update the Culture of Safety NSO training.
• Assist the VP with the maintenance and development of safety-related policies, procedures, and instruction manuals.
• When restrictions are placed on clients or sites, ensure that all new or revised restrictions are properly communicated with clinical, medical, administrative, security, facility, and other relevant staff
• Participate in the preparation, execution, and follow-up for accreditation and certification surveys/audits.
• Support the Quality Team with completion of medication audits, mortality reviews, visits to clinical or administrative teams, site visits, targeted investigations, change management tasks, and internal communication.
• Coordinate with and educate employees regarding documenting medical necessity for services being requested for authorization, by partnering with clinicians to ensure documentation is timely and supports the services identified. 
• Acts as a resource to other departments regarding utilization management matters, coverage guidelines, and assisting as needed with clinical or claims issues.
• Participate in meetings, committees, and work groups as needed.
• Perform other related duties and/or projects as assigned.

Qualifications

• Bachelor’s degree in Social Work, Psychology, Counseling, or health related field required, Master’s degree preferred.
• Licensed Clinical Professional Counselor or Licensed Clinical Social Worker in Illinois preferred.
• Minimum two years’ experience in a healthcare, social services, or non-profit setting, preferably in a clinical/environmental safety or risk management role.
• Ability to spend minimum 2 days per week on site, with availability for more on site days as work duties require.
• Experience in reviewing health care services for medical necessity in a clinical setting or in a utilization management role or similar activities preferred.
• Excellent interpersonal, organizational and oral/written communication skills, and ability to engage with stakeholders at all levels.
• Knowledge of change management is preferred
• Superior ability to collaborate and interact with other programs/departments
• Experience with developing workflows and/or processes highly preferred
• Maintenance of confidentiality and adherence to HIPAA regulations
• Detail oriented and ability to complete projects with strict deadlines
• Advanced computer skills in Microsoft Office applications, and ability to learn new computer systems

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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Manager, Talent Access @ MCRA, an IQVIA Business | Talent Acquisition Professional

Overview

Provide oversight and management of the Safety team members for all clinical aspects of the development and execution of all Clinical Events Committees (CEC), Data Safety Monitoring Boards (DSMB), Medical Monitor Reviews and supporting the requests from our clients and regulatory agencies in relationship to the safety events of the trials. Execute Clinical Affairs functions in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), and any other applicable regulatory requirements.

Responsibilities and Duties

• Be the point of escalation for all Safety related issues that occur.
• Support all business development activities that involve Safety
• Provide clinical expertise to MCRAs cross functional leaders
• Ensure that all CEC & DSMB meetings are performed uniformly across the company, according to the study protocol, SOPs, ICH/GCP regulations and study-specific manuals and procedures.
• Lead and direct project teams to ensure deliverables meet project timelines.
• Track and report on progress of the meeting preparation and after the conclusion of a meeting.
• Develop Charter and supporting documents for all meetings.
• Write safety event narratives to support committee review
• Work in collaboration with the clinical project management team, regulatory team, statistics team, and data management team to ensure the meeting materials are developed in a timely manager and all supporting documents that are available are accessible for the meeting.
• Support the team in recruiting members to participate in the meetings.
• Manage independent physician consultants to serve as CEC, DSMB or Medical Monitors on clinical studies
• Support business development team in client/project recruitment efforts.
• Provide ongoing process training to study personnel as needed.
• Develop and maintain positive relationships both internal and external to projects, including clients, team members, and committee members.
• Maintain knowledge of current GCP, FDA, and other applicable regulations.

Required Knowledge, Skills, and Experience

• Education: Bachelors degree in a health sciences discipline.
• Certification/Licensure: Not applicable.
• Experience: Minimum five years of experience in clinical trials management or related field and minimum of three years supporting safety meetings.
• Availability: Assume one to three evening(s) per week will be dedicated to participating in the safety meetings. The hours of this role will be flexible due to the demands of client scheduling.

Other:

• Knowledge of clinical project management, GCPs, and FDA guidelines on safety committees.
• Demonstrated ability to manage multiple projects simultaneously.
• Proficiency with MS Office applications.
• Experience using Electronic Data Capture (EDC) and clinical trial management systems for project management and monitoring.
• Demonstrated professional oral and written communications.
• Ability to read, write, speak and understand English required.

Work environment

• Collaborative with a strong team spirit.
• Interaction with peers, subordinates, and managers.
• Entitled to a work environment that is free from harassment.
• Prolonged periods sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.
• Visual acuity to read records and documents.
• Travel (up to 30%) is required for this role pending client requests of having in-person meetings.

Seniority level

• Seniority level Director

Employment type

• Employment type Full-time

Job function

• Job function Consulting
• Industries Medical Equipment Manufacturing

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MCRA, an IQVIA business, is a leading medical device advisory firm and clinical research organization (CRO). MCRA's value contribution rests within its industry experience at integrating five business value creatorsregulatory, clinical research, reimbursement, healthcare compliance, and quality assuranceto provide a dynamic, market-leading effort from concept to commercialization. MCRA's integrated application of these key value-creating functions provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, New York, NY, and a global presence in Japan and Europe and serves more than 1500 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices.

Overview

Provide oversight and management of the Safety team members for all clinical aspects of the development and execution of all Clinical Events Committees (CEC), Data Safety Monitoring Boards (DSMB), Medical Monitor Reviews and supporting the requests from our clients and regulatory agencies in relationship to the safety events of the trials. Execute Clinical Affairs functions in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), and any other applicable regulatory requirements.

Responsibilities and Duties

• Be the point of escalation for all Safety related issues that occur.
• Support all business development activities that involve Safety
• Provide clinical expertise to MCRAs cross functional leaders
• Ensure that all CEC & DSMB meetings are performed uniformly across the company, according to the study protocol, SOPs, ICH/GCP regulations and study-specific manuals and procedures.
• Lead and direct project teams to ensure deliverables meet project timelines.
• Track and report on progress of the meeting preparation and after the conclusion of a meeting.
• Develop Charter and supporting documents for all meetings.
• Write safety event narratives to support committee review
• Work in collaboration with the clinical project management team, regulatory team, statistics team, and data management team to ensure the meeting materials are developed in a timely manager and all supporting documents that are available are accessible for the meeting.
• Support the team in recruiting members to participate in the meetings.
• Manage independent physician consultants to serve as CEC, DSMB or Medical Monitors on clinical studies
• Support business development team in client/project recruitment efforts.
• Provide ongoing process training to study personnel as needed.
• Develop and maintain positive relationships both internal and external to projects, including clients, team members, and committee members.
• Maintain knowledge of current GCP, FDA, and other applicable regulations.

Qualifications

• Education: Bachelors degree in a health sciences discipline.

• Certification/Licensure: Not applicable.

• Experience: Minimum five years of experience in clinical trials management or related field and minimum of three years supporting safety meetings.

• Availability: Assume one to three evening(s) per week will be dedicated to participating in the safety meetings. The hours of this role will be flexible due to the demands of client scheduling.

Other:

• Knowledge of clinical project management, GCPs, and FDA guidelines on safety committees.
• Demonstrated ability to manage multiple projects simultaneously.
• Proficiency with MS Office applications.
• Experience using Electronic Data Capture (EDC) and clinical trial management systems for project management and monitoring.
• Demonstrated professional oral and written communications.
• Ability to read, write, speak and understand English required.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.

MCRA, an IQVIA business, is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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Currently our client employees have the opportunity to directly impact global health through COVID-19 vaccine development and post-authorization global administration, and the portfolio is poised to deliver in other important therapeutic areas with unmet medical need. The Clinical Safety group ensures the safety use of our vaccines and therapeutics through continuous assessment of the totality of the available safety data, proactive and effective risk management, and transparent communication of the risks throughout the product life cycle while ensuring the highest standards of quality and compliance. To meet our commitment to patient safety as our highest priority we are growing our Clinical Safety team to ensure integrated safety signal identification, rapid signal refinement/validation including real world data, and signal evaluation integrated with lifecycle risk management planning and feedback to risk minimization activities.

We are seeking an experienced safety physician who wants to have an impact on our COVID-19 vaccine program and on future programs by supporting our Clinical Safety and Pharmacovigilance efforts. This individual will report to the Clinical Safety Lead and will help drive the medical safety aspects of clinical trial safety evaluation, post marketing surveillance, regulatory reporting, risk management/minimization, and external communication with cross functional partners.

Our client is seeking candidates aligned with its culture centered on bold, collaborative, curious, and relentless values which enable innovation with its vaccines and therapeutics to benefit patients.

JOB RESPONSIBILITIES

• Provide clinical and scientific safety expertise and leadership.
• Engage cross-functional internal workstreams including therapeutic area development, biostatistics, clinical operations, and regulatory affairs.
• Manage engagements with external organizations, key opinion leaders, and advisors.
• Maintain accountability for case series analysis of adverse events performed by global safety medical directors and pharmacovigilance scientists as well as disposition of passive surveillance data mining alerts and safety issues from other sources.
• Lead clinical safety sections of regulatory documents and preparation for meetings with regulatory and public health authorities as well as advisory committees.
• Provide clinical and strategic input to the design of clinical trials, signal refinement/validation activities, post authorization studies, risk minimization, and risk communication.
• Serve as an exemplary leader, mentor, and trainer.

JOB REQUIREMENTS

• MD or non-US equivalent with residency training, board certification, and at least three years of clinical practice experience.
• Additional graduate training in public health, epidemiology, or statistics is preferred.
• Minimum 3 years experience in clinical safety and pharmacovigilance in an industry setting, with experience in vaccine safety preferred. Exceptional candidates from academic, regulatory, and clinical development settings will also be considered.
• Proven ability to:
  • Lead technical teams and deliver high-quality results within established timelines
  • Utilize technology supporting pharmacovigilance
  • Integrate concepts and guidelines from FDA, EMA, PMDA and other regulatory agencies, public health agencies and nongovernmental organizations, and clinical practice groups
  • Investigate new safety issues
  • Communicate medical product benefits and risks to regulatory and public health authorities as well as the public
• Ability to thrive in a fast-paced environment while providing appropriate attention to detail
• Excellent analytical, problem-solving, strategic planning, and interpersonal skills.

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At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Your Role: Senior Research Scientist, Non-Clinical Safety & Toxicology

We are seeking an experienced non-clinical toxicology / safety scientist to join the Global Non-Clinical Development team in Global Clinical Development. As the Senior Research Scientist, Non-Clinical Safety & Toxicology you will be responsible for, or will assist with, human (user & consumer) safety and target animal safety program strategy and execution at all phases of global veterinary pharmaceutical drug/product and feed additive research and development, product safety assessments, and support for marketed products.

This role applies toxicology and immunology expertise to assess safety risks across the full product lifecycle, from early development through commercialization. Responsibilities include evaluating potential safety concerns related to product design, manufacturing changes, deviations, or consumer complaints that could impact animal safety or end-user health. The role involves preparing Product Safety Assessments (PSAs) for products in development, production, or on the market, and compiling medical and toxicological data to assess potential health risks for consumers and end users.

Your Responsibilities:

• Independently design, organize, monitor, report, and resolve issues related to outsourced in vitro  and in vivo  safety/toxicology studies, utilizing external CROs and/or consultants as needed. These studies may involve typical rodent and non-rodent species. Target animal safety evaluations may include companion animals (dogs and cats) as well as food-producing animals (e.g., cattle, pigs, chickens).

• Conduct literature reviews and author expert reports, position papers, safety and hazard/risk assessments, and other strategic scientific, technical, or medical evaluations to address safety considerations for veterinary drugs (small molecules and biologics), feed additives, excipients, E&L substances, impurities, or other chemicals.

• Provide internal expert guidance, including expert statements, health-based exposure limits (e.g., PDEs, OELs), and target safety assessments.

• Engage with regulatory agencies to address safety concerns for both products in development and marketed products, including preparing and submitting documentation and delivering formal presentations.

• Collaborate closely with colleagues in Manufacturing, Quality, Human Food Safety, ADME/PK, and Environmental Safety to accomplish multidisciplinary non-clinical objectives for projects and products.

• Proactively participate in global, cross-functional project teams (e.g., clinical, pharmaceutical development, regulatory affairs, quality, manufacturing) within a matrix organization to drive project success.

• Maintain technical and professional expertise by staying current with scientific developments and sharing relevant insights and best practices within the organization.

What You Need to Succeed (Minimum Qualifications):

• Education: DVM and/or PhD (preferred) in toxicology or another relevant biomedical science discipline (e.g., veterinary medicine, biology, chemistry) with at least 5 years of industry experience in non-clinical safety, or a Master’s degree with at least 7 years of relevant experience.

• Experience: Demonstrated ability to apply toxicology and risk assessment principles aligned with global regulations and guidance. Experience in non-clinical veterinary drug development, including target safety assessments, in silico predictions, and safety evaluations throughout product life cycles. Strong background in large molecule, biologics, vaccine, and antibody development, as well as using in vitro/in vivo data and literature to support product development and registration.

• Top 2 skills: A strong, collaborative team-player with expertise in toxicology and immunology with strong risk assessment capabilities. Highly skilled in cross-functional collaboration, regulatory strategy, and effective communication of complex scientific concepts.

What Will Give You a Competitive Edge (Preferred Qualifications):

• Board certification as a toxicologist (ERT, DABT, or equivalent).

• Immunological background, especially related to monoclonal antibodies and emerging platform technologies for indications like dermatology or pain.

• Deep understanding of US, European, and international veterinary drug development, as well as agribusiness practices for companion and farm animals.

• Strong working knowledge of GLP regulations and experience with in silico toxicity prediction tools.

• Ability to manage complex projects independently, with strong organizational and time management skills.

• Excellent written and verbal communication skills in English.

Additional Information:

• Travel: Up to 30% annually (domestic and international)

• Location: Global Elanco Headquarters - Greenfield, IN - Hybrid Work Environment (Soon to be Indianapolis, Indiana NEW HQ October 2025)

Don’t meet every single requirement?   Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!  

Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:

• Multiple relocation packages

• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)

• 8-week parental leave

• 9 Employee Resource Groups

• Annual bonus offering

• Flexible work arrangements

• Up to 6% 401K matching

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

University Overview
The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023.
Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.
Posted Job Title
Data Safety Monitoring Board
Job Profile Title
Temporary Employee - Non-Exempt
Job Description Summary
Temporary Employee - Non-Exempt
Job Description
Temporary Employee - Non-Exempt. Serve on Data Safety Monitoring Board for sponsored research projects with Dr. Michael Perlis as PI.
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$7.25 - $62.50 Hourly Rate
Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.
Equal Opportunity Statement
The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics) , citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law .
Special Requirements A background check may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
University Benefits
+ Health and Life: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare.
+ Retirement: Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
Please note that benefit eligibility is determined/based on ACA guidelines.
The University of Pennsylvania's special character is reflected in the wide variety of backgrounds, experiences, and perspectives of the Penn community. We seek talented faculty and staff who will constitute a vibrant community and help create an educational and working environment that best supports the University's commitment to excellence in teaching, research, and scholarship. The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status, or any class protected under applicable federal, state or local law.

Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

Position: Manager, Business Analyst, In-Vivo & Non-Clinical Safety Product Team, Research BI&T

Location: Cambridge, MA

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology, and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Overview: The Business Analyst in the In-Vivo & Non-Clinical Safety Product Team will play a key role in bridging the gap between scientific research needs and IT solutions, specifically focusing on In-Vivo & Non-Clinical Safety Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELN). This is a hands-on role where the successful candidate will work closely with researchers, lab personnel, and IT teams to gather requirements, design solutions, and ensure the effective implementation and support of LIMS and ELN applications.

If you want an exciting and rewarding career that is meaningful, consider joining our diverse team!

Desired Candidate Characteristics:

• Strong commitment to a career in technology with a passion for healthcare.

• Proven experience with LIMS and ELN systems.

• Degree in Biological or Chemical sciences with prior research experience.

• Knowledge of l In-Vivo & Non-Clinical Safety laboratory experimental processes and data management.

• Technical knowledge and support experience for LIMS and ELN systems in biotech/pharma research labs.

• Experience in business analysis and conducting training on LIMS and ELN platforms.

• Ability to work collaboratively with scientists, IT colleagues, vendors, and contractors.

• Demonstrated ability to work across a matrixed organizational model.

• Strong understanding of business needs and commitment to delivering the best user experience.

• Excellent communication skills.

• Agility to learn new tools and processes.

Key Responsibilities:

• Requirements Gathering: Collaborate with researchers, lab personnel, and other stakeholders to understand and document their needs and requirements for LIMS and ELN applications.

• Solution Design: Work with IT and software development teams to design and propose solutions that meet the identified requirements, ensuring alignment with best practices and regulatory standards.

• Support: Support end users with configuration, customization, and deployment of LIMS and ELN systems. Provide support during implementation phases to ensure smooth transitions and minimal disruption to lab operations.

• Manage Jira boards, create user stories and specifications for developers and testers. Support end users in use of LIMS, ELN, and other scientific applications and troubleshooting user issues. Conduct structured training in use of LIMS, ELN, and other scientific applications.

Qualifications:

• Education: Degree in Life Sciences, Information Technology, Computer Science, or a related field.

• Experience: Minimum 3 years of experience as a Business Analyst, preferably in a life sciences research or laboratory environment. Experience with LIMS and ELN systems is highly desirable.

• Technical Skills: Proficiency in LIMS and ELN applications, as well as familiarity with database management, data integration, and software development lifecycle (SDLC) methodologies.

• Analytical Skills: Strong analytical and problem-solving skills, with the ability to translate complex scientific requirements into technical solutions.

• Communication Skills: Excellent verbal and written communication skills, with the ability to effectively interact with both technical and non-technical stakeholders.

• LIMS/ELN Implementation: Experience in leading rollouts of LIMS/ELN platforms to large user groups.

• Regulatory Knowledge: Understanding of regulatory requirements and quality standards in the life sciences industry, such as GxP, FDA, and ISO standards.

Preferred Qualifications:

• Experience with LIMS and ELN platforms (e.g. Genedata, Dotmatics, Revvity, Sapio, Benchling, etc.).

• Certification in Business Analysis (e.g., CBAP, CCBA) or Project Management (e.g., PMP).

• Familiarity with data analytics and reporting tools.

Why You Should Apply:

Around the world, we are passionate about impacting the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments, and ongoing support in their roles. Applicants can request accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Bristol-Myers Squibb Company is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview:

Cambridge Crossing: $118,650 - $143,778

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company: Bristol-Myers Squibb

Req Number: R1593801

Updated: 2025-08-24 03:30:54.238 UTC

Location: Cambridge Crossing-MA

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
Position: Manager, Business Analyst, In-Vivo & Non-Clinical Safety Product Team, Research BI&T
Location: Cambridge, MA
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology, and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Position Overview: The Business Analyst in the In-Vivo & Non-Clinical Safety Product Team will play a key role in bridging the gap between scientific research needs and IT solutions, specifically focusing on In-Vivo & Non-Clinical Safety Laboratory Information Management Systems (LIMS) and Electronic Laboratory Notebooks (ELN). This is a hands-on role where the successful candidate will work closely with researchers, lab personnel, and IT teams to gather requirements, design solutions, and ensure the effective implementation and support of LIMS and ELN applications.
If you want an exciting and rewarding career that is meaningful, consider joining our diverse team!
Desired Candidate Characteristics:
+ Strong commitment to a career in technology with a passion for healthcare.
+ Proven experience with LIMS and ELN systems.
+ Degree in Biological or Chemical sciences with prior research experience.
+ Knowledge of l In-Vivo & Non-Clinical Safety laboratory experimental processes and data management.
+ Technical knowledge and support experience for LIMS and ELN systems in biotech/pharma research labs.
+ Experience in business analysis and conducting training on LIMS and ELN platforms.
+ Ability to work collaboratively with scientists, IT colleagues, vendors, and contractors.
+ Demonstrated ability to work across a matrixed organizational model.
+ Strong understanding of business needs and commitment to delivering the best user experience.
+ Excellent communication skills.
+ Agility to learn new tools and processes.
Key Responsibilities:
+ Requirements Gathering: Collaborate with researchers, lab personnel, and other stakeholders to understand and document their needs and requirements for LIMS and ELN applications.
+ Solution Design: Work with IT and software development teams to design and propose solutions that meet the identified requirements, ensuring alignment with best practices and regulatory standards.
+ Support: Support end users with configuration, customization, and deployment of LIMS and ELN systems. Provide support during implementation phases to ensure smooth transitions and minimal disruption to lab operations.
+ Manage Jira boards, create user stories and specifications for developers and testers. Support end users in use of LIMS, ELN, and other scientific applications and troubleshooting user issues. Conduct structured training in use of LIMS, ELN, and other scientific applications.
Qualifications:
+ Education: Degree in Life Sciences, Information Technology, Computer Science, or a related field.
+ Experience: Minimum 3 years of experience as a Business Analyst, preferably in a life sciences research or laboratory environment. Experience with LIMS and ELN systems is highly desirable.
+ Technical Skills: Proficiency in LIMS and ELN applications, as well as familiarity with database management, data integration, and software development lifecycle (SDLC) methodologies.
+ Analytical Skills: Strong analytical and problem-solving skills, with the ability to translate complex scientific requirements into technical solutions.
+ Communication Skills: Excellent verbal and written communication skills, with the ability to effectively interact with both technical and non-technical stakeholders.
+ LIMS/ELN Implementation: Experience in leading rollouts of LIMS/ELN platforms to large user groups.
+ Regulatory Knowledge: Understanding of regulatory requirements and quality standards in the life sciences industry, such as GxP, FDA, and ISO standards.
Preferred Qualifications:
+ Experience with LIMS and ELN platforms (e.g. Genedata, Dotmatics, Revvity, Sapio, Benchling, etc.).
+ Certification in Business Analysis (e.g., CBAP, CCBA) or Project Management (e.g., PMP).
+ Familiarity with data analytics and reporting tools.
Why You Should Apply:
Around the world, we are passionate about impacting the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion, and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services, and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments, and ongoing support in their roles. Applicants can request accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Bristol-Myers Squibb Company is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Compensation Overview:**
Cambridge Crossing: $118,650 - $143,778
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R1593801
**Updated:** 2025-08-25 04:45:29.246 UTC
**Location:** Cambridge Crossing-MA
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.