5,328 Clinical Research Management jobs in the United States
Research Scientist – Clinical Study Management
Posted 7 days ago
Job Viewed
Job Description
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: Research Scientist – Clinical Study Management
The Research Scientist – Clinical Study Management position is responsible for the management of pivotal, regulated and non-pivotal studies at Elanco sites and Contract Research Organizations. You will work collaboratively to support experimental design and scientific interpretation of study results, and production of any materials for patents or publications.
Your Responsibilities:
Oversee Study Design and Execution: Lead the design and execution of clinical studies, including GLP, GCP, pivotal and non-pivotal studies, acting as Study Director for GLP safety studies and Study Investigator for clinical studies, ensuring overall conduct and scientific integrity.
Ensure Comprehensive Regulatory Compliance: Maintain rigorous compliance with Good Laboratory Practice (GLP) - 21 CFR Part 58, Good Clinical Practices (GCP), and all applicable internal and external guidelines (e.g., SOPs, HSE, Animal Welfare, IACUC approvals), including managing protocol excursions and corrective actions.
Manage End-to-End Study Documentation: Drive the development and completion of study protocols and final reports, support the creation and maintenance of all study-related SOPs, templates, and forms, and ensure the accurate interpretation, analysis, documentation, and secure archiving of all raw data and specimens.
Facilitate Cross-Functional Coordination & Communication: Coordinate with study staff for protocol training and execution preparation, organize IVP supply management, and ensure continuous, clear communication between the Study Director, Sponsor Representative, Investigator, Clinical team, QA, and Study Monitor.
Contribute to Scientific Advancement & IP: Support the generation of potential patents and publications based on study findings, leveraging study results to advance scientific knowledge and intellectual property within Elanco.
What You Need to Succeed (minimum qualifications):
MS with 4+ years, BS with 7+ years of experience, or Doctorate level education (e.g., PhD, DVM, MD) with 2+ years in a relevant industry.
Experience managing clinical study initiation, execution, and completion and thorough understanding in coordinating various clinical functional groups including regulatory, clinical laboratory, clinical execution, veterinary services, and animal care personnel.
Background with both USDA and EU Regulatory guidelines preferred.
What will give you a competitive edge (preferred qualifications):
Experience with clinical study management in the Animal Health industry is highly desired.
Strong organizational and time management skills.
Advanced ability to define problems, collect data, establish facts, and draw valid conclusions.
Experience with biological vaccines, small molecules, and large molecules.
Experience with or willing to gain experience with Pain and Dermatology models.
Additional Information:
Travel: Up to 10%
Location: Fort Dodge, Iowa
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
Senior Data Management Professional - Data Science - Data Management Lab
Posted today
Job Viewed
Job Description
Location
New York
Business Area
Data
Ref #
**Description & Requirements**
Bloomberg runs on data, and in the Data department we're responsible for acquiring, interpreting and supplying data insights to our clients. Our Data teams work to collect, analyse, process, and publish the data which is the backbone of our iconic Bloomberg Terminal -- the data which ultimately moves the financial markets! We're responsible for delivering this data, news, and analytics through innovative technology -- quickly and accurately.
The Data Management Lab (DML) sits within the Data organization, supporting Data's pursuit of data management excellence by aligning industry best practices with Bloomberg's established expertise in financial market data. DML empowers our data professionals to make their products "ready-to-use" by promoting increased data discoverability, accessibility, appraisability, interoperability, and analysis-readiness.
As a Data Management Professional, you will play a pivotal role in ensuring the delivery of high-quality data to our clients while driving impactful business decisions. You will be an integral member of a collaborative set of teams, Quality Methods & Insights under DML that includes Data Quality, Business Intelligence and Process Engineering serving as a centre of excellence for the rest of the teams in the Data organisation. A key aspect of this role involves leading initiatives to appraise and enhance the quality of our datasets, partnering closely with Data product and Engineering teams to champion effective solutions. Simultaneously, you will leverage your analytical expertise to support the development of scalable methods and tools for analysing product, process, and people data. The analytical insights will directly support data-driven decision-making aimed at achieving quality enhancements and process optimisation across the organization. You will also contribute to the ongoing refinement of data management best practices.
**As a valued member of our team, we'll trust you to:**
+ Lead global initiatives focused on data science applications within the realms of data quality, data product development, and operational efficiency
+ Design and run studies to uncover root causes of data quality issues, using techniques such as hypothesis testing, clustering, and regression analysis
+ Develop statistical models to detect data anomalies, predict quality issues, and optimize data manufacturing pipelines by leveraging appropriate methodologies
+ Deliver actionable insights through advanced analytics, and compelling data storytelling to support business decision making and innovation
+ Collaborate with data stakeholders and engineering partner to translate high-impact questions into scalable data science solutions
+ Build statistical and analytical capabilities within the team; mentor others in applying best practices in modelling and experimentation
**You'll need to have a strong combination of the following:**
_*Please note we use years of experience as a guide but we certainly will consider applications from all candidates who are able to demonstrate the skills necessary for the role._
+ A PhD or Master's degree in Data Science, Economics, Statistics or a related quantitative field
+ 3-5 years' experience designing research studies as well as performing analysis such as data profiling, predictive modelling, and causal analysis
+ Strong coding skills ideally in Python and experience with SQL for data querying
+ Familiarity with version control systems (e.g., Git) and a collaborative development workflow (e.g., GitHub, GitLab)
+ Experience working in a data quality, data governance, or data management environment is a major plus (knowledge of DAMA, DCAM, etc. is welcome)
+ Excellent project management skills and the ability to communicate complex findings clearly to both technical and non-technical audiences
+ Knowledge of financial markets and Bloomberg products is a plus
**Does this sound like you?**
Apply if you think we're a good match. We'll get in touch to let you know what the next steps are.
Salary Range = - USD Annually + Benefits + Bonus
The referenced salary range is based on the Company's good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level.
We offer one of the most comprehensive and generous benefits plans available and offer a range of total rewards that may include merit increases, incentive compensation (exempt roles only), paid holidays, paid time off, medical, dental, vision, short and long term disability benefits, 401(k) +match, life insurance, and various wellness programs, among others. The Company does not provide benefits directly to contingent workers/contractors and interns.
Discover what makes Bloomberg unique - watch our for an inside look at our culture, values, and the people behind our success.
Bloomberg is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of age, ancestry, color, gender identity or expression, genetic predisposition or carrier status, marital status, national or ethnic origin, race, religion or belief, sex, sexual orientation, sexual and other reproductive health decisions, parental or caring status, physical or mental disability, pregnancy or parental leave, protected veteran status, status as a victim of domestic violence, or any other classification protected by applicable law.
Bloomberg is a disability inclusive employer. Please let us know if you require any reasonable adjustments to be made for the recruitment process. If you would prefer to discuss this confidentially, please email
Lead Product Data Management Engineer (Configuration & Data Management)
Posted 1 day ago
Job Viewed
Job Description
At Boeing, we innovate and collaborate to make the world a better place. We're committed to fostering an environment for every teammate that's welcoming, respectful and inclusive, with great opportunity for professional growth. Find your future with us.
**Boeing Defense, Space & Security** (BDS) Air Dominance is seeking a **Lead Product Data Management Engineer (Configuration & Data Management)** (Level 4) to support the **Systems Engineering Integration** **& Test (SEIT) Team** in **Berkeley, MO** .
The successful candidate will be responsible for leading and performing configuration planning, identification, change control, tracking, and verification, extracting technical product definition data, and facilitating program baseline management.
**Position Responsibilities**
+ Understand customer and supplier technical baseline management requirements.
+ Generate configuration management plans and processes.
+ Assign and maintain product and document identification.
+ Evaluate and lead the coordination of proposed engineering changes.
+ Prepare change control documents such as Engineering Change Proposals (ECP), Requests for Variance (RFV), Change Documents/Change Requests (CD/CRs), Conduct program Change Control Boards (CCB), perform configuration audits, generate configuration status reports, and others.
+ Generate Technical Data Packages (TDP) through interpretation of technical data delivery requirements and analysis and compilation of product design definition data
+ Collaborate with and advise fellow configuration management engineers on configuration management principles and job practices.
+ Collaborate with customers.
+ Engage in program planning.
**This position is expected to be 100% onsite. The selected candidate will be required to work onsite.**
**Travel may be required up to 10% of the time; Domestically and/or internationally depending on business needs.**
**This position requires the ability to obtain a U.S. Security Clearance for which the U.S. Government requires U.S. Citizenship. An interim and/or final U.S. Secret Clearance Post-Start is required.**
**Basic Qualifications (Required Skills/Experience)**
+ Bachelor of Science degree from an accredited course of study in engineering, engineering technology (includes manufacturing engineering technology), chemistry, physics, mathematics, data science, or computer science
+ 9+ years related work experience or an equivalent combination of technical education and experience
+ 5+ years using Excel to perform data analysis.
+ 5+ years editing PDF and Word files.
**Preferred Qualifications (Desired Skills/Experience)**
+ Demonstrated interest in personal learning and development as well as process improvement.
+ Ability to accomplish tasks through formal channels and informal networks; an understanding of the cultures of organizations and ability to apply this information in a way that strengthens the organization's strategic plan and profitability.
+ Attention to detail.
+ Excellent spoken and written communication across organizations.
+ Use of scripting to collect data
**Typical Education & Experience**
Education/experience typically acquired through advanced technical education from an accredited course of study in engineering, engineering technology (includes manufacturing engineering technology), computer science, engineering data science, mathematics, physics or chemistry (e.g. Bachelor) and typically 9 or more years' related work experience or an equivalent combination of technical education and experience or non-US equivalent qualifications. In the USA, ABET accreditation is the preferred, although not required, accreditation standard.
**Drug Free Workplace**
Boeing is a Drug Free Workplace where post offer applicants and employees are subject to testing for marijuana, cocaine, opioids, amphetamines, PCP, and alcohol when criteria is met as outlined in our policies.
**Employee Referral**
Referral to this job is eligible for bonus to qualifying candidates.
**Total Rewards**
At Boeing, we strive to deliver a Total Rewards package that will attract, engage and retain the top talent. Elements of the Total Rewards package include competitive base pay and variable compensation opportunities.
The Boeing Company also provides eligible employees with an opportunity to enroll in a variety of benefit programs, generally including health insurance, flexible spending accounts, health savings accounts, retirement savings plans, life and disability insurance programs, and a number of programs that provide for both paid and unpaid time away from work.
The specific programs and options available to any given employee may vary depending on eligibility factors such as geographic location, date of hire, and the applicability of collective bargaining agreements.
Pay is based upon candidate experience and qualifications, as well as market and business considerations. Summary pay range: $113,050 - $152,950
Applications for this position will be accepted until **Nov. 05, 2025**
**Export Control Requirements:** This position must meet export control compliance requirements. To meet export control compliance requirements, a "U.S. Person" as defined by 22 C.F.R. §120.15 is required. "U.S. Person" includes U.S. Citizen, lawful permanent resident, refugee, or asylee.
**Export Control Details:** US based job, US Person required
**Education**
Bachelor's Degree or Equivalent Required
**Relocation**
This position offers relocation based on candidate eligibility.
**Security Clearance**
This position requires the ability to obtain a U.S. Security Clearance for which the U.S. Government requires U.S. Citizenship. An interim and/or final U.S. Secret Clearance Post-Start is required.
**Visa Sponsorship**
Employer will not sponsor applicants for employment visa status.
**Shift**
This position is for 1st shift
**Equal Opportunity Employer:**
Boeing is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law.
Boeing is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, physical or mental disability, genetic factors, military/veteran status or other characteristics protected by law.
Data Management Clerk
Posted 42 days ago
Job Viewed
Job Description
We are looking for a detail-oriented Data Management Clerk to support our team by accurately organizing, entering, and maintaining company data. In this role, you will ensure that all records are updated, verified, and easily accessible to support daily operations and reporting needs. The ideal candidate is highly organized, dependable, and comfortable handling sensitive information with confidentiality.
Responsibilities:
- Collect, enter, and update information in company databases and record-keeping systems
- Review data for accuracy, completeness, and consistency before and after entry
- Maintain organized electronic and physical filing systems for quick retrieval of records
- Assist with generating reports, summaries, and data analysis as requested
- Identify and correct data discrepancies in collaboration with team members
- Ensure compliance with company policies and data security procedures
- Provide general clerical and administrative support as needed
Qualifications:
- High school diploma or equivalent; additional coursework in office administration, data management, or IT is a plus
- Previous experience in data entry, records management, or clerical support preferred
- Strong computer skills, including proficiency in Microsoft Office (Excel, Word, Outlook)
- Familiarity with database or records management systems is an advantage
- Excellent organizational and multitasking abilities
- Strong attention to detail and accuracy in work
- Ability to work independently as well as part of a team
Benefits:
- Competitive pay
- Health, dental, and vision insurance
- Retirement savings plan with employer contribution
- Paid time off, holidays, and sick leave
- Opportunities for professional growth and training
- Supportive and collaborative work environment
Company Details
Data Management Lead
Posted 1 day ago
Job Viewed
Job Description
**Location:** Fully Remote (US based) Must be able to accommodate West Coast hours.
**About Us:** At Parexel, we are dedicated to advancing clinical research and supporting medical affairs with innovative solutions. We are seeking a dynamic and experienced Data Management Lead to join our team. If you have a passion for clinical research, strong project management skills, and a knack for data management, we want to hear from you!
**Who You Are:**
**Required:**
+ BS or MS in Life Sciences, Data/Computer Science, OR equivalent industry experience.
+ 7+ years experience in pharmaceutical/biotech clinical data management / Biometrics (clinical trial data and/or Real World Data)
+ Medical affairs experience (Phase IIIB - IV trials experience); Late Phase Oncology
+ Strong project management experience
+ Demonstrated collaboration and superb communication skills, both written and oral (proficiency in English required).
+ Proficient in CDISC data standards, ICH-GCP, and working in regulated environments, with a solid understanding of biological principles and scientific curiosity.
+ Validated project management skills, capable of managing multiple requests and priorities, with proven leadership in decision-making, negotiation, motivation, and influencing.
+ Experience with data analytics and visualization tools, an entrepreneurial mindset, self-direction, and the ability to mentor others while learning new techniques.
+ Experience in leading DM study teams, overseeing trial data activities, and collecting clinical trial and/or Real World Data, with a good understanding of molecule and disease area strategies and the healthcare environment.
+ Ownership and accountability relative to key accountabilities in the job description.
+ Ability to travel as required.
+ Written and oral fluency in English.
**Preferred:**
+ Proficiency in programming languages such as SAS, R, Python, and SQL, with experience in advanced analytics approaches (e.g., machine learning, AI).
+ Proficient with tools for analyzing large data sources with computationally intensive steps (e.g., SQL, parallelization, Hadoop, Spark) and producing interactive outputs (e.g., Shiny, Tableau).
+ Experience with SDTM implementation, CDISC standards, standardized technologies (e.g., MedDRA, WHODrug), and reproducible research practices like version control and literate programming.
+ BSN, RN, RPh, Pharm D, PA, MPH, or other applicable health professional credentials, with contributions to open-source packages, libraries, or functions.
**What you will be doing:**
**Responsibilities will include:**
+ Develop risk management strategies and proactively manage timelWhat ines to ensure successful oversight and delivery of studies and projects.
+ Engage with stakeholders to understand their needs, influence their understanding of decisions, inform them of key deliverables, and adapt to changing milestones.
+ Partner with relevant functions for external data vendor selection and management, ensuring standards-compliant data transfer agreements and fit-for-purpose data models.
+ Advise teams and stakeholders on best practices for data collection, propose innovative solutions, and ensure high-quality, compliant data.
+ Use surveillance tools to review data at an aggregate level, identifying patterns or anomalies to ensure high-quality results.
+ Organize and integrate data from various sources, maintaining its value through the application of FAIR principles, and support stakeholders' data insight needs from collection to analysis.
**Cross-functional Data Management Leadership:**
+ Manage and coordinate the integration and utilization of all ancillary systems.
+ Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive resolution with cross-functional stakeholders as part of the Risk Management Plan.
+ Review and analyze metrics to derive meaningful summaries of study health and trends.
+ Review Master Services Agreements, Service Level Agreements, and contracts to manage toward sponsor-specific metric targets/Key Performance Indicators.
+ Attend cross-functional meetings, prepare meeting agendas and minutes, and comply with action and decision logs.
**Project Financial and Resource Management:**
+ Ensure appropriate project-level resourcing of staff and staff assignments.
+ Regularly review and update Data Management resources to ensure alignment with contracted budgets, project resource forecasts, actuals, and demand.
+ Determine and resolve the root cause of Data Management-related project variances in a timely manner, including negotiating/raising changes in scope.
**Company Initiatives:**
+ Provide Data Management functional input, considering the impact on Data Management and Parexel as a whole.
+ Support other functions by providing meaningful feedback on initiatives.
+ Ensure Parexel-requested information entered into management systems is accurate and regularly updated.
**Training:**
+ Maintain training compliance as per job roles assigned, including on-the-job training.
+ Deliver project-specific training to internal Data Management teams.
+ Address training needs based on identified development goals.
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Data Management Lead
Posted 4 days ago
Job Viewed
Job Description
**Location:** Fully Remote (US based) Must be able to accommodate West Coast hours.
**About Us:** At Parexel, we are dedicated to advancing clinical research and supporting medical affairs with innovative solutions. We are seeking a dynamic and experienced Data Management Lead to join our team. If you have a passion for clinical research, strong project management skills, and a knack for data management, we want to hear from you!
**Who You Are:**
**Required:**
+ BS or MS in Life Sciences, Data/Computer Science, OR equivalent industry experience.
+ 7+ years experience in pharmaceutical/biotech clinical data management / Biometrics (clinical trial data and/or Real World Data)
+ Medical affairs experience (Phase IIIB - IV trials experience); Late Phase Oncology
+ Strong project management experience
+ Demonstrated collaboration and superb communication skills, both written and oral (proficiency in English required).
+ Proficient in CDISC data standards, ICH-GCP, and working in regulated environments, with a solid understanding of biological principles and scientific curiosity.
+ Validated project management skills, capable of managing multiple requests and priorities, with proven leadership in decision-making, negotiation, motivation, and influencing.
+ Experience with data analytics and visualization tools, an entrepreneurial mindset, self-direction, and the ability to mentor others while learning new techniques.
+ Experience in leading DM study teams, overseeing trial data activities, and collecting clinical trial and/or Real World Data, with a good understanding of molecule and disease area strategies and the healthcare environment.
+ Ownership and accountability relative to key accountabilities in the job description.
+ Ability to travel as required.
+ Written and oral fluency in English.
**Preferred:**
+ Proficiency in programming languages such as SAS, R, Python, and SQL, with experience in advanced analytics approaches (e.g., machine learning, AI).
+ Proficient with tools for analyzing large data sources with computationally intensive steps (e.g., SQL, parallelization, Hadoop, Spark) and producing interactive outputs (e.g., Shiny, Tableau).
+ Experience with SDTM implementation, CDISC standards, standardized technologies (e.g., MedDRA, WHODrug), and reproducible research practices like version control and literate programming.
+ BSN, RN, RPh, Pharm D, PA, MPH, or other applicable health professional credentials, with contributions to open-source packages, libraries, or functions.
**What you will be doing:**
**Responsibilities will include:**
+ Develop risk management strategies and proactively manage timelWhat ines to ensure successful oversight and delivery of studies and projects.
+ Engage with stakeholders to understand their needs, influence their understanding of decisions, inform them of key deliverables, and adapt to changing milestones.
+ Partner with relevant functions for external data vendor selection and management, ensuring standards-compliant data transfer agreements and fit-for-purpose data models.
+ Advise teams and stakeholders on best practices for data collection, propose innovative solutions, and ensure high-quality, compliant data.
+ Use surveillance tools to review data at an aggregate level, identifying patterns or anomalies to ensure high-quality results.
+ Organize and integrate data from various sources, maintaining its value through the application of FAIR principles, and support stakeholders' data insight needs from collection to analysis.
**Cross-functional Data Management Leadership:**
+ Manage and coordinate the integration and utilization of all ancillary systems.
+ Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive resolution with cross-functional stakeholders as part of the Risk Management Plan.
+ Review and analyze metrics to derive meaningful summaries of study health and trends.
+ Review Master Services Agreements, Service Level Agreements, and contracts to manage toward sponsor-specific metric targets/Key Performance Indicators.
+ Attend cross-functional meetings, prepare meeting agendas and minutes, and comply with action and decision logs.
**Project Financial and Resource Management:**
+ Ensure appropriate project-level resourcing of staff and staff assignments.
+ Regularly review and update Data Management resources to ensure alignment with contracted budgets, project resource forecasts, actuals, and demand.
+ Determine and resolve the root cause of Data Management-related project variances in a timely manner, including negotiating/raising changes in scope.
**Company Initiatives:**
+ Provide Data Management functional input, considering the impact on Data Management and Parexel as a whole.
+ Support other functions by providing meaningful feedback on initiatives.
+ Ensure Parexel-requested information entered into management systems is accurate and regularly updated.
**Training:**
+ Maintain training compliance as per job roles assigned, including on-the-job training.
+ Deliver project-specific training to internal Data Management teams.
+ Address training needs based on identified development goals.
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Data Management Lead
Posted 4 days ago
Job Viewed
Job Description
**Location:** Fully Remote (US based) Must be able to accommodate West Coast hours.
**About Us:** At Parexel, we are dedicated to advancing clinical research and supporting medical affairs with innovative solutions. We are seeking a dynamic and experienced Data Management Lead to join our team. If you have a passion for clinical research, strong project management skills, and a knack for data management, we want to hear from you!
**Who You Are:**
**Required:**
+ BS or MS in Life Sciences, Data/Computer Science, OR equivalent industry experience.
+ 7+ years experience in pharmaceutical/biotech clinical data management / Biometrics (clinical trial data and/or Real World Data)
+ Medical affairs experience (Phase IIIB - IV trials experience); Late Phase Oncology
+ Strong project management experience
+ Demonstrated collaboration and superb communication skills, both written and oral (proficiency in English required).
+ Proficient in CDISC data standards, ICH-GCP, and working in regulated environments, with a solid understanding of biological principles and scientific curiosity.
+ Validated project management skills, capable of managing multiple requests and priorities, with proven leadership in decision-making, negotiation, motivation, and influencing.
+ Experience with data analytics and visualization tools, an entrepreneurial mindset, self-direction, and the ability to mentor others while learning new techniques.
+ Experience in leading DM study teams, overseeing trial data activities, and collecting clinical trial and/or Real World Data, with a good understanding of molecule and disease area strategies and the healthcare environment.
+ Ownership and accountability relative to key accountabilities in the job description.
+ Ability to travel as required.
+ Written and oral fluency in English.
**Preferred:**
+ Proficiency in programming languages such as SAS, R, Python, and SQL, with experience in advanced analytics approaches (e.g., machine learning, AI).
+ Proficient with tools for analyzing large data sources with computationally intensive steps (e.g., SQL, parallelization, Hadoop, Spark) and producing interactive outputs (e.g., Shiny, Tableau).
+ Experience with SDTM implementation, CDISC standards, standardized technologies (e.g., MedDRA, WHODrug), and reproducible research practices like version control and literate programming.
+ BSN, RN, RPh, Pharm D, PA, MPH, or other applicable health professional credentials, with contributions to open-source packages, libraries, or functions.
**What you will be doing:**
**Responsibilities will include:**
+ Develop risk management strategies and proactively manage timelWhat ines to ensure successful oversight and delivery of studies and projects.
+ Engage with stakeholders to understand their needs, influence their understanding of decisions, inform them of key deliverables, and adapt to changing milestones.
+ Partner with relevant functions for external data vendor selection and management, ensuring standards-compliant data transfer agreements and fit-for-purpose data models.
+ Advise teams and stakeholders on best practices for data collection, propose innovative solutions, and ensure high-quality, compliant data.
+ Use surveillance tools to review data at an aggregate level, identifying patterns or anomalies to ensure high-quality results.
+ Organize and integrate data from various sources, maintaining its value through the application of FAIR principles, and support stakeholders' data insight needs from collection to analysis.
**Cross-functional Data Management Leadership:**
+ Manage and coordinate the integration and utilization of all ancillary systems.
+ Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive resolution with cross-functional stakeholders as part of the Risk Management Plan.
+ Review and analyze metrics to derive meaningful summaries of study health and trends.
+ Review Master Services Agreements, Service Level Agreements, and contracts to manage toward sponsor-specific metric targets/Key Performance Indicators.
+ Attend cross-functional meetings, prepare meeting agendas and minutes, and comply with action and decision logs.
**Project Financial and Resource Management:**
+ Ensure appropriate project-level resourcing of staff and staff assignments.
+ Regularly review and update Data Management resources to ensure alignment with contracted budgets, project resource forecasts, actuals, and demand.
+ Determine and resolve the root cause of Data Management-related project variances in a timely manner, including negotiating/raising changes in scope.
**Company Initiatives:**
+ Provide Data Management functional input, considering the impact on Data Management and Parexel as a whole.
+ Support other functions by providing meaningful feedback on initiatives.
+ Ensure Parexel-requested information entered into management systems is accurate and regularly updated.
**Training:**
+ Maintain training compliance as per job roles assigned, including on-the-job training.
+ Deliver project-specific training to internal Data Management teams.
+ Address training needs based on identified development goals.
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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About the latest Clinical research management Jobs in United States !
Data Management Lead
Posted 4 days ago
Job Viewed
Job Description
**Location:** Fully Remote (US based) Must be able to accommodate West Coast hours.
**About Us:** At Parexel, we are dedicated to advancing clinical research and supporting medical affairs with innovative solutions. We are seeking a dynamic and experienced Data Management Lead to join our team. If you have a passion for clinical research, strong project management skills, and a knack for data management, we want to hear from you!
**Who You Are:**
**Required:**
+ BS or MS in Life Sciences, Data/Computer Science, OR equivalent industry experience.
+ 7+ years experience in pharmaceutical/biotech clinical data management / Biometrics (clinical trial data and/or Real World Data)
+ Medical affairs experience (Phase IIIB - IV trials experience); Late Phase Oncology
+ Strong project management experience
+ Demonstrated collaboration and superb communication skills, both written and oral (proficiency in English required).
+ Proficient in CDISC data standards, ICH-GCP, and working in regulated environments, with a solid understanding of biological principles and scientific curiosity.
+ Validated project management skills, capable of managing multiple requests and priorities, with proven leadership in decision-making, negotiation, motivation, and influencing.
+ Experience with data analytics and visualization tools, an entrepreneurial mindset, self-direction, and the ability to mentor others while learning new techniques.
+ Experience in leading DM study teams, overseeing trial data activities, and collecting clinical trial and/or Real World Data, with a good understanding of molecule and disease area strategies and the healthcare environment.
+ Ownership and accountability relative to key accountabilities in the job description.
+ Ability to travel as required.
+ Written and oral fluency in English.
**Preferred:**
+ Proficiency in programming languages such as SAS, R, Python, and SQL, with experience in advanced analytics approaches (e.g., machine learning, AI).
+ Proficient with tools for analyzing large data sources with computationally intensive steps (e.g., SQL, parallelization, Hadoop, Spark) and producing interactive outputs (e.g., Shiny, Tableau).
+ Experience with SDTM implementation, CDISC standards, standardized technologies (e.g., MedDRA, WHODrug), and reproducible research practices like version control and literate programming.
+ BSN, RN, RPh, Pharm D, PA, MPH, or other applicable health professional credentials, with contributions to open-source packages, libraries, or functions.
**What you will be doing:**
**Responsibilities will include:**
+ Develop risk management strategies and proactively manage timelWhat ines to ensure successful oversight and delivery of studies and projects.
+ Engage with stakeholders to understand their needs, influence their understanding of decisions, inform them of key deliverables, and adapt to changing milestones.
+ Partner with relevant functions for external data vendor selection and management, ensuring standards-compliant data transfer agreements and fit-for-purpose data models.
+ Advise teams and stakeholders on best practices for data collection, propose innovative solutions, and ensure high-quality, compliant data.
+ Use surveillance tools to review data at an aggregate level, identifying patterns or anomalies to ensure high-quality results.
+ Organize and integrate data from various sources, maintaining its value through the application of FAIR principles, and support stakeholders' data insight needs from collection to analysis.
**Cross-functional Data Management Leadership:**
+ Manage and coordinate the integration and utilization of all ancillary systems.
+ Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive resolution with cross-functional stakeholders as part of the Risk Management Plan.
+ Review and analyze metrics to derive meaningful summaries of study health and trends.
+ Review Master Services Agreements, Service Level Agreements, and contracts to manage toward sponsor-specific metric targets/Key Performance Indicators.
+ Attend cross-functional meetings, prepare meeting agendas and minutes, and comply with action and decision logs.
**Project Financial and Resource Management:**
+ Ensure appropriate project-level resourcing of staff and staff assignments.
+ Regularly review and update Data Management resources to ensure alignment with contracted budgets, project resource forecasts, actuals, and demand.
+ Determine and resolve the root cause of Data Management-related project variances in a timely manner, including negotiating/raising changes in scope.
**Company Initiatives:**
+ Provide Data Management functional input, considering the impact on Data Management and Parexel as a whole.
+ Support other functions by providing meaningful feedback on initiatives.
+ Ensure Parexel-requested information entered into management systems is accurate and regularly updated.
**Training:**
+ Maintain training compliance as per job roles assigned, including on-the-job training.
+ Deliver project-specific training to internal Data Management teams.
+ Address training needs based on identified development goals.
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Data Management Lead
Posted 4 days ago
Job Viewed
Job Description
**Location:** Fully Remote (US based) Must be able to accommodate West Coast hours.
**About Us:** At Parexel, we are dedicated to advancing clinical research and supporting medical affairs with innovative solutions. We are seeking a dynamic and experienced Data Management Lead to join our team. If you have a passion for clinical research, strong project management skills, and a knack for data management, we want to hear from you!
**Who You Are:**
**Required:**
+ BS or MS in Life Sciences, Data/Computer Science, OR equivalent industry experience.
+ 7+ years experience in pharmaceutical/biotech clinical data management / Biometrics (clinical trial data and/or Real World Data)
+ Medical affairs experience (Phase IIIB - IV trials experience); Late Phase Oncology
+ Strong project management experience
+ Demonstrated collaboration and superb communication skills, both written and oral (proficiency in English required).
+ Proficient in CDISC data standards, ICH-GCP, and working in regulated environments, with a solid understanding of biological principles and scientific curiosity.
+ Validated project management skills, capable of managing multiple requests and priorities, with proven leadership in decision-making, negotiation, motivation, and influencing.
+ Experience with data analytics and visualization tools, an entrepreneurial mindset, self-direction, and the ability to mentor others while learning new techniques.
+ Experience in leading DM study teams, overseeing trial data activities, and collecting clinical trial and/or Real World Data, with a good understanding of molecule and disease area strategies and the healthcare environment.
+ Ownership and accountability relative to key accountabilities in the job description.
+ Ability to travel as required.
+ Written and oral fluency in English.
**Preferred:**
+ Proficiency in programming languages such as SAS, R, Python, and SQL, with experience in advanced analytics approaches (e.g., machine learning, AI).
+ Proficient with tools for analyzing large data sources with computationally intensive steps (e.g., SQL, parallelization, Hadoop, Spark) and producing interactive outputs (e.g., Shiny, Tableau).
+ Experience with SDTM implementation, CDISC standards, standardized technologies (e.g., MedDRA, WHODrug), and reproducible research practices like version control and literate programming.
+ BSN, RN, RPh, Pharm D, PA, MPH, or other applicable health professional credentials, with contributions to open-source packages, libraries, or functions.
**What you will be doing:**
**Responsibilities will include:**
+ Develop risk management strategies and proactively manage timelWhat ines to ensure successful oversight and delivery of studies and projects.
+ Engage with stakeholders to understand their needs, influence their understanding of decisions, inform them of key deliverables, and adapt to changing milestones.
+ Partner with relevant functions for external data vendor selection and management, ensuring standards-compliant data transfer agreements and fit-for-purpose data models.
+ Advise teams and stakeholders on best practices for data collection, propose innovative solutions, and ensure high-quality, compliant data.
+ Use surveillance tools to review data at an aggregate level, identifying patterns or anomalies to ensure high-quality results.
+ Organize and integrate data from various sources, maintaining its value through the application of FAIR principles, and support stakeholders' data insight needs from collection to analysis.
**Cross-functional Data Management Leadership:**
+ Manage and coordinate the integration and utilization of all ancillary systems.
+ Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive resolution with cross-functional stakeholders as part of the Risk Management Plan.
+ Review and analyze metrics to derive meaningful summaries of study health and trends.
+ Review Master Services Agreements, Service Level Agreements, and contracts to manage toward sponsor-specific metric targets/Key Performance Indicators.
+ Attend cross-functional meetings, prepare meeting agendas and minutes, and comply with action and decision logs.
**Project Financial and Resource Management:**
+ Ensure appropriate project-level resourcing of staff and staff assignments.
+ Regularly review and update Data Management resources to ensure alignment with contracted budgets, project resource forecasts, actuals, and demand.
+ Determine and resolve the root cause of Data Management-related project variances in a timely manner, including negotiating/raising changes in scope.
**Company Initiatives:**
+ Provide Data Management functional input, considering the impact on Data Management and Parexel as a whole.
+ Support other functions by providing meaningful feedback on initiatives.
+ Ensure Parexel-requested information entered into management systems is accurate and regularly updated.
**Training:**
+ Maintain training compliance as per job roles assigned, including on-the-job training.
+ Deliver project-specific training to internal Data Management teams.
+ Address training needs based on identified development goals.
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Data Management Lead
Posted 4 days ago
Job Viewed
Job Description
**Location:** Fully Remote (US based) Must be able to accommodate West Coast hours.
**About Us:** At Parexel, we are dedicated to advancing clinical research and supporting medical affairs with innovative solutions. We are seeking a dynamic and experienced Data Management Lead to join our team. If you have a passion for clinical research, strong project management skills, and a knack for data management, we want to hear from you!
**Who You Are:**
**Required:**
+ BS or MS in Life Sciences, Data/Computer Science, OR equivalent industry experience.
+ 7+ years experience in pharmaceutical/biotech clinical data management / Biometrics (clinical trial data and/or Real World Data)
+ Medical affairs experience (Phase IIIB - IV trials experience); Late Phase Oncology
+ Strong project management experience
+ Demonstrated collaboration and superb communication skills, both written and oral (proficiency in English required).
+ Proficient in CDISC data standards, ICH-GCP, and working in regulated environments, with a solid understanding of biological principles and scientific curiosity.
+ Validated project management skills, capable of managing multiple requests and priorities, with proven leadership in decision-making, negotiation, motivation, and influencing.
+ Experience with data analytics and visualization tools, an entrepreneurial mindset, self-direction, and the ability to mentor others while learning new techniques.
+ Experience in leading DM study teams, overseeing trial data activities, and collecting clinical trial and/or Real World Data, with a good understanding of molecule and disease area strategies and the healthcare environment.
+ Ownership and accountability relative to key accountabilities in the job description.
+ Ability to travel as required.
+ Written and oral fluency in English.
**Preferred:**
+ Proficiency in programming languages such as SAS, R, Python, and SQL, with experience in advanced analytics approaches (e.g., machine learning, AI).
+ Proficient with tools for analyzing large data sources with computationally intensive steps (e.g., SQL, parallelization, Hadoop, Spark) and producing interactive outputs (e.g., Shiny, Tableau).
+ Experience with SDTM implementation, CDISC standards, standardized technologies (e.g., MedDRA, WHODrug), and reproducible research practices like version control and literate programming.
+ BSN, RN, RPh, Pharm D, PA, MPH, or other applicable health professional credentials, with contributions to open-source packages, libraries, or functions.
**What you will be doing:**
**Responsibilities will include:**
+ Develop risk management strategies and proactively manage timelWhat ines to ensure successful oversight and delivery of studies and projects.
+ Engage with stakeholders to understand their needs, influence their understanding of decisions, inform them of key deliverables, and adapt to changing milestones.
+ Partner with relevant functions for external data vendor selection and management, ensuring standards-compliant data transfer agreements and fit-for-purpose data models.
+ Advise teams and stakeholders on best practices for data collection, propose innovative solutions, and ensure high-quality, compliant data.
+ Use surveillance tools to review data at an aggregate level, identifying patterns or anomalies to ensure high-quality results.
+ Organize and integrate data from various sources, maintaining its value through the application of FAIR principles, and support stakeholders' data insight needs from collection to analysis.
**Cross-functional Data Management Leadership:**
+ Manage and coordinate the integration and utilization of all ancillary systems.
+ Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive resolution with cross-functional stakeholders as part of the Risk Management Plan.
+ Review and analyze metrics to derive meaningful summaries of study health and trends.
+ Review Master Services Agreements, Service Level Agreements, and contracts to manage toward sponsor-specific metric targets/Key Performance Indicators.
+ Attend cross-functional meetings, prepare meeting agendas and minutes, and comply with action and decision logs.
**Project Financial and Resource Management:**
+ Ensure appropriate project-level resourcing of staff and staff assignments.
+ Regularly review and update Data Management resources to ensure alignment with contracted budgets, project resource forecasts, actuals, and demand.
+ Determine and resolve the root cause of Data Management-related project variances in a timely manner, including negotiating/raising changes in scope.
**Company Initiatives:**
+ Provide Data Management functional input, considering the impact on Data Management and Parexel as a whole.
+ Support other functions by providing meaningful feedback on initiatives.
+ Ensure Parexel-requested information entered into management systems is accurate and regularly updated.
**Training:**
+ Maintain training compliance as per job roles assigned, including on-the-job training.
+ Deliver project-specific training to internal Data Management teams.
+ Address training needs based on identified development goals.
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.