Manager, Research & Development
Posted 3 days ago
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A brief overview The Research and Development Manager serves a cross functional role within the organization. This individual drives research and development activities with his/her creativity, enthusiasm and expertise in peptide chemistry. He/she makes key contributions to maintain and increase the technical skill level for the efficient production of peptides and holds responsibility for the process development and manufacturing of peptides and other novel products. What you will do Plan, prioritize and oversee synthesis of catalog and custom products Evaluate new technologies for the benefit of peptide production Investigate new processes and products Improve processes for existing products- economy, safety and ecology Explore and apply new technologies and instrumentation for peptide manufacturing (e.g. using automation) and facilitate implementation in Production Supervise and guide staff to meet quality requirements and timelines, and to comply with SOPs Evaluate performance of staff and train staff Make conscious and efficient use of resources Document results for the benefit of production and other departments Stay on top of new developments in commercial peptide synthesis Present concepts and results during discussions with customers Qualifications Master's Degree in organic chemistry or biochemistry with relevant work experience PhD in organic chemistry (preferred) Minimum 3 years’ experience in peptide chemistry in an industrial setup Management experience from previous role(s) (preferred) Thorough understanding of the peptide manufacturing process and equipment Proven track record of scientific achievements Broad knowledge of modern organic chemistry Routinely work with hazardous materials and manage hazardous waste in a satellite accumulation area Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one’s time Communicate effectively and ability to function well in a team environment Base Annual Salary Range: Manager $126,800 - $74,350 Sr. Manager: 136.640 - 187,880 Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training. Total Rewards We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days. Corporate Social Responsibility Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Platinum Medal status in their assessment of Bachem. Bachem Americas is an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status #J-18808-Ljbffr
Project Manager, IS Clinical Research
Posted 3 days ago
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Job Description
1 week ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. This range is provided by Jobot Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $58.00/hr - $5.00/hr Want to learn more about this role and Jobot Consulting? Click our Jobot Consulting logo and follow our LinkedIn page! Job details Local Hybrid Project Manager, IS Clinical Research- 12 Month Contract in Los Angeles, CA. This Jobot Consulting Job is hosted by Robert Reyes Are you a fit? Easy Apply now by clicking the "Easy Apply" button and sending us your resume. Salary 58 - 65 per hour A Bit About Us Sr Project Manager, Revenue Cycle-100% Remote 12 Month Contract Opportuntity! Soarian Financials And Clinical Project Management Experience Required. Prestige Hospital System Placed #1 in both California in a broad assessment of excellence in hospital-based patient care. Apply today to learn more! Why join us? Sr Project Manager, Revenue Cycle-100% Remote 12 Month Contract Opportuntity! Soarian Financials And Clinical Project Management Experience Required. Why join us? Competitive Salary Variety of benefits and perks designed to support your well-being and professional growth. Here are some of the key benefits Health and Medical Benefits Comprehensive health plan options, including medical, dental, and vision coverage, as well as flexible spending accounts to offset medical costs. Retirement Benefits Retirement plans to help you secure your financial future. Tuition Benefits Free tuition for yourself or an immediate family member after two years of employment. Time Off Paid and unpaid time off for vacation, personal health, and family care. Well-being Programs Resources to support your physical, mental, and spiritual health. Employee Discounts Discounts on sports tickets, gym memberships, event tickets, and more. Professional Development Opportunities for growth and development through various training programs and resources. If you are passionate, thrive in a fast-paced environment and are ready to take your career to the next level, we would love to hear from you. Job Details Summary We are seeking an experienced Health IT Project Manager with strong skills in eliciting and documenting business and technical requirements, conducting thorough project analysis, and driving alignment across diverse stakeholder groups. The ideal candidate will have a solid foundation in project management practices within healthcare environments, with a bonus for hands-on experience managing technical projects involving AWS services, machine learning, or predictive analytics. This role will oversee complex health data innovation and digital transformation initiatives, collaborating with clinicians, researchers, technical teams, and executive stakeholders to deliver impactful technology solutions that improve patient care and operational outcomes. Required Knowledge And Experience Lead end-to-end project management for IT initiatives in a healthcare IT setting. Facilitate discovery sessions and stakeholder interviews to elicit and document clear, actionable requirements. Perform gap analysis, impact analysis, and translate business needs into functional specifications. Develop project charters, workplans, status reports, and other PMO artifacts. Manage scope, timelines, risks, and resources across matrixed teams. Coordinate with vendors and internal IT to drive timely implementation. Communicate effectively with executive leadership, providing transparent updates and recommendations. Preferred Qualifications Understanding of clinical trials research and associated processes Research budget management experience Experience with clinical data research projects and/or working in an academic medical environment. Familiarity with interfacing HL7 Clinical Document.Architecture (CDA) and/or Fast Healthcare Interoperability Resources (FHIR) PMP or similar certification. Experience with ServiceNow or enterprise project management systems. Familiarity with HIPAA, IRB, and healthcare data privacy standards. Prior project management work with AWS cloud services, machine learning, or predictive analytics platforms is highly desirable. Key Responsibilities Under the direction of the Portfolio Manager the successful candidate will Participate in both strategic planning and tactical execution of clinical research data projects in analysis and implementation; facilitate communications between project partners, clinical researchers and data scientists as they relate to supporting research data acquisition and utilization issues and provide oversight and direction to project team members. Provides program support for BioData Catalyst by leading project management planning, execution, reporting, and close out activities as necessary to ensure the program meets approved program strategies, milestones, and deliverables Provides coordination, management, and oversight of project management activities for the Health Data Informatics and Research team in a matrixed, cross-functional environment Ensures program compliance with all policies and procedures related to project management, contract relations, purchasing, and fiscal planning Assists in the preparation of program reports, including monthly updates and quarterly, semi-annual, and annual reports Coordinates meeting management support for the assigned projects and programs, including drafting agendas, taking meeting notes/minutes and recording and monitoring action items for initiative committees, sub-committees, peer review panels, external advisory panels, scrum teams, program reviews, and other stakeholders as needed Communicates effectively with senior-level leads within the Health System, Keck School of Medicine, and the University to compose both business and scientific documents and ensure smooth operations of the Program Maintain all status related communications with internal and external stakeholders (i.e., affected parties) Special Knowledge, Skills & Abilities Experience leading a variety of multi-person projects simultaneously and comfortable switching gears depending on business requirements. Ability to work effectively with diverse stakeholders, including highly collaborative multi - PI grants, faculty, academic leadership, and staff. Experience managing diverse teams including resources with divergent skills (e.g technical, clinical, analytics) to achieve harmonized research data provision supporting network or individual study objectives. Expertise leading teams responsible for cross-platform research data acquisition and management. Strong attention to detail and highly organized. Proficiency with project management tools, MS Project, MS Excel, MS Word, MS Teams, MS Visio Virtual/cloud based data management and administration including regulated security and privacy configurations required for research (IRB, HIPPA.) Compliance and information security as relations to Deep understanding of complex EMR, Research and Public Health system workflows with a focus on data generation and exchange. Familiarity with healthcare data organization, storage, cataloging, and analytics Familiarity with complex research data management tools, standards, and techniques that support various modes of data ingestion and curation. Bonus familiarities with ontologoies and/or coding systems such as ICD, CPT, LOINC and MedDRA. Bonus Familiarity with the Observational Medical Outcomes Partnership (OMOP), Observational Health Data Sciences and Informatics (OHDSI) tooling, and Research Electronic Data Capture (REDCap). Bonus Experience with Cerner Electronical Medical Record System Bonus Experience with Amazon Web Services and their offerings Interested in hearing more? Easy Apply now by clicking the "Easy Apply" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance. Want to learn more about this role and Jobot Consulting? Click our Jobot Consulting logo and follow our LinkedIn page! Seniority level Seniority level Not Applicable Employment type Employment type Contract Job function Job function Project Management and Information Technology Industries Hospitals and Health Care, Medical Practices, and Mental Health Care Referrals increase your chances of interviewing at Jobot Consulting by 2x Get notified about new Project Manager jobs in Poway, CA . Senior Project Manager, Customer Experience Carlsbad, CA 90,000.00- 100,000.00 1 month ago People Planning & Initiatives Program Manager EPMO Project Manager - (Senior Level) (REMOTE) Project Manager - Remote (Exp in a shared service or BPO Organizations & Customer Facing) Project Manager (2-3 Yrs of Project Management, Customer Facing & Project Server Exp) Remote Assistant Project Manager (Project Biologist I) | Remote in SoCal Del Mar, CA 85,000.00- 95,000.00 2 weeks ago San Diego Metropolitan Area 195,000.00- 252,500.00 3 days ago Project Manager - Ubuntu Embedded Systems Senior Technical Program Manager - Workday Financial Management (REMOTE) Associate Launch & Proposal Manager – Remote (Must be available for Pacific Hours) Associate Launch & Proposal Manager - Remote (Must be available for Pacific Hours) We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Program Manager Research Development Evaluation
Posted today
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This Program Manager position typically reports to a Senior Program Manager and is responsible for the planning, managing, and technical performance of one or more established engineering program(s) in support of the Department of Defense (DoD) Test Resource Management Center (TRMC) SkyRange program. Directs all phases of program(s) from initiation through delivery. Responsible for program(s) which represent moderate future growth in distinct products, services, or components. Applies established technologies that require advanced principles, theories, concepts, and techniques to provide solutions to a variety of technical problems. Typically accomplishes objectives through functional support. Responsible for decisions that could have an extended impact on outcomes where erroneous decisions could result in critical delays and modifications to programs.
**DUTIES & RESPONSIBILITIES:**
+ Direct all phases of the program(s) from conceptualization through completion, including acquisition, planning, and managing technical performance to ensure quality, business, and financial objectives are attained.
+ Develop and coordinate program plans or delivery methods which usually serve a single customer.
+ Collaborate with technical staff and/or Division/Group executive management to develop and implement current, annual, and long-term technical, schedule, quality, business, and financial objectives for the program(s). May also contribute to the development of Group/Company objectives which have a long-range forecast projected to continue for multiple years.
+ Collaborate with engineering to establish design concepts, criteria, and engineering efforts for product research, development, testing, and integration.
+ Interact with management and customer representatives regarding programs, operational decisions, scheduling requirements, and contractual clarifications. Act as primary contact for program issues.
+ Influence and coordinate the preparation of proposals, business plans, proposal work statements and specifications, operating budgets, and financial terms/conditions of contract(s). Influence contract acquisitions, negotiations and modifications.
+ Ensure technical leadership and excellence is maintained by directing and participating in the planning, attraction, selection, retention, and development of the required management, professional, and technical talent.
+ Act as the primary customer contact for program activities and lead program review sessions/meetings with customers to discuss cost, schedule, and technical performance.
+ Identify program issues and provide leadership in developing solutions such as re-allocation of resources or modifying contract specifications.
+ Lead the development of new business opportunities and expansion of existing business opportunities.
+ Develop and manage new workflows and processes within the program as required.
+ Participate with Group management in pursuing business partnerships, alliances, and joint ventures that enhance the capabilities of the Group/Company and may result in new products, programs and business opportunities.
+ Direct the development of and ensure the security of proprietary technology and maintain the strict confidentiality of sensitive information.
+ Direct and manage day to day programmatic activities.
+ Execute contract performance requirements and deliver Contract Deliverable Requirements List (CDRL) in a timely manner.
+ Other duties as assigned or required.
We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply.49924
**Job Qualifications:**
+ Typically requires a Bachelors, Masters or PhD in engineering, science or a related technical field as well as eleven or more years of progressively complex program administration experience. May substitute equivalent experience in lieu of education.
+ Demonstrates extensive technical expertise and application of program management principles, concepts, and practice as well as comprehensive program management and leadership skills including organizing, planning, scheduling, and coordinating workloads to meet established deadlines or milestones.
+ Must be able to develop solutions to complex problems that require coordination of technologies and issues across program requirements.
+ Strong communication, leadership, presentation, and interpersonal skills are required to enable an effective interface with other departments, all levels of management, professional and support staff, customers, potential customers, and government representatives.
+ Customer focused, must be able to work on a self-initiated basis and in a team environment.
+ Ability to obtain and maintain a DoD security clearance required.
+ Proficiency in Microsoft Office and scheduling applications.
+ Program Management certification (desired).
**Salary:** $112,320 - $205,058 **Travel Percentage Required** 0 - 25 **Relocation Assistance Provided** Not Provided **US Citizenship Required?** Yes **Clearance Required?** Desired **Clearance Level** Senior (8+ years) **Workstyle** Hybrid
General Atomics is committed to hiring and retaining a diverse workforce. We are an Equal Opportunity/Affirmative Action Employer and will consider all qualified applicants for employment without regard to race, color, religion, religious creed, ancestry, gender, pregnancy, sex, sexual orientation, transitioning status, gender identity, gender expression, national origin, age, genetic information, military and veteran status, marital status, medical condition, mental disability, physical disability, or any other basis protected by local, state, or federal law. EEO is the law. We also prohibit compensation discrimination under all applicable laws. To learn more visit Notices.pdf. U.S. Citizenship is required for certain positions.
Clinical Research Associate - Sponsor Dedicated
Posted today
Job Viewed
Job Description
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions:
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications:
- Bachelor's Degree Degree in scientific discipline or health care preferred. Req
- Requires at least 1.5 years of year of on-site monitoring experience. Req
- Equivalent combination of education, training and experience may be accepted in lieu of degree. Req
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
- i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. potential base pay range for this role, when annualized, is $57,500.00 - $226,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Clinical Research Associate, Sponsor Dedicated
Posted today
Job Viewed
Job Description
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
- Bachelor's Degree Degree in scientific discipline or health care preferred.
- Requires at least 2 years of year of on-site monitoring experience.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
- i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. potential base pay range for this role, when annualized, is $57,500.00 - $226,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Clinical Research Associate - Sponsor Dedicated
Posted today
Job Viewed
Job Description
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
- Bachelor's Degree Degree in scientific discipline or health care preferred.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- Some organizations require completion of CRA training program or prior monitoring experience.
- Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Clinical Research Associate, Sponsor Dedicated
Posted today
Job Viewed
Job Description
Job Overview
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
- Bachelor's Degree Degree in scientific discipline or health care preferred.
- Requires at least months of on-site monitoring experience.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
- i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
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Clinical Research Associate, Sponsor Dedicated
Posted today
Job Viewed
Job Description
Whether you're beginning or continuing your career as a CRA, this role is an ideal stepping-stone. You'll have training and development to plan and progress your career in the direction you choose. And you won't do it alone - you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion and bonus awards.
Award winning and innovative, we'll give you access to cutting-edge in-house technology, allowing you to work on global projects but with a regional / home state travel remit, so no need for national travel in certain countries. You'll be building a smart and flexible career with no limits.
**While projects vary, your typical responsibilities might include:**
+ Performing site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation
+ Supporting the development of a subject recruitment plan
+ Establishing regular lines of communication plus administering protocol and related study training to assigned sites
+ Evaluating the quality and integrity of site practices - escalating quality issues as appropriate
+ Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
You will need to be comfortable collaborating and communicating with a variety of colleagues and customers. Ideally, you will also have a good basic knowledge of applicable clinical research regulatory requirements.
You should have:
+ A Bachelor's degree in a health care or other scientific discipline or educational equivalent
+ Successful completion of a CRA Trainee Program or at least three months of on-site monitoring experience. 2 years of clinical research coordinator experience strongly preferred.
+ Alternatively, you should have an equivalent combination of education, training and experience
If you want to make an impact in the global research market, where we are working to make a real difference in patient health, we ask you to apply now and join our team.
#CRASDAJD
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. potential base pay range for this role, when annualized, is $64,000.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Research Intern - Biology (Part Time)
Posted today
Job Viewed
Job Description
Requisition ID: 6531
Location:
La Jolla, CA, US
Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. As Lundbeck's North American hub for early-stage drug discovery, the Lundbeck La Jolla Research Center positions our company to deliver transformative treatments for brain disease. Join us on our journey of discovery!
**SUMMARY:**
Lundbeck La Jolla Research Center, Inc. (LLJRC) is a discovery research arm of H. Lundbeck A/S. Our mission is to develop innovative medicines that address significant unmet need in the treatment of psychiatric and neurological disorders. LLJRC is seeking a motivated student intern to support Lundbeck's CNS discovery programs. The successful candidate will be a highly organized and detail-oriented student with a positive attitude and willingness to learn. If you thrive in a dynamic, fast-paced environment and enjoy creative and challenging work, Lundbeck may be the company for you.
**ESSENTIAL FUNCTIONS:**
This will be an invaluable experience for a student looking to attain basic laboratory skills and gain hands on experience using essential equipment for pharmacology research. There is the potential for growth with opportunities specializing in advanced biology techniques such as enzyme/protein preparations and mammalian cell culture.
Key responsibilities include:
+ Washing and autoclaving glassware
+ Maintaining consumables and reagents
+ Pouring SDS-PAGE gels
+ Managing compounds using liquid handling robotic machinery
+ Other miscellaneous laboratory and office duties
**This is a year round Internship. You will have a flexible schedule but will be expected to work on average 10 - 20 hours per week.**
**REQUIRED EDUCATION, EXPERIENCE AND SKILLS:**
+ Enrolled towards a BS or equivalent degree in the sciences.
+ Must be able to work productively in a fast-paced collaborative team environment.
+ Excellent communication skills
+ Willingness to learn
**PREFERRED EDUCATION, EXPERIENCE AND SKILLS:**
+ Practical experience in a laboratory environment.
+ Completed introductory Biology and/or Chemistry coursework.
**TRAVEL:**
+ Willingness/Ability to travel up to 0% domestically
The range displayed is specifically for those potential hires who will work orresidein the state ofCalifornia, if selected for this role, and may vary based onvarious factorssuch as the candidate's qualifications, skills, competencies, andproficiencyfor the role. Salary Pay Range:$21/hour to $23/hour. This position is not eligible to participate in the company's benefits except those benefits that are required by law. Applications accepted on an ongoing basis.
**Why Lundbeck**
Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on theU.S. career site ( .
_Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit theU.S. career site ( ._
_Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify ( ._
**About Lundbeck**
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.
**About Lundbeck**
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.
(Senior) Clinical Research Associate - Sponsor Dedicated
Posted today
Job Viewed
Job Description
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Essential Functions
- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Act as a mentor for clinical staff including conducting co-monitoring and training visits.
- Collaborate and liaise with study team members for project execution support as appropriate.
- If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
- If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Qualifications
- Bachelor's Degree Degree in scientific discipline or health care preferred. Req
- Requires at least 4 years of year of on-site monitoring experience.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Strong therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. potential base pay range for this role, when annualized, is $71,900.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled