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Senior Clinical Data Manager
BeOne Medicines. Assign and/or drive all aspects of clinical trial data management activities from study start-up through database lock .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in clinical data management, particularly in oncology, with a strong understanding of ICH regulations and the phases of clinical trials. Proficient in data cleaning, reconciliation, and the development of data management documentation, while effectively leading cross-functional teams.
Highest-signal resume keywords
Clinical Data ManagementOncology ExperienceEDC System ProficiencyProject Management SkillsRegulatory Compliance Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data CleaningData ReconciliationDatabase ManagementReport GenerationUser Acceptance TestingData Management DocumentationData Review ActivitiesMetrics AnalysisClinical Trial PhasesSOP Development
Soft Skills
Strong Communication SkillsProblem-Solving AbilityDetail-OrientedInterpersonal SkillsLeadership Capability
Tools & Technologies
Microsoft OfficeMedidata RaveClinical DatabasesECRF DevelopmentData Management Plans
Industry Keywords
Pharmaceutical IndustryBiotechnology IndustryICH GuidelinesCross-Functional TeamworkClinical Trials
About the role
Key responsibilities & impact- Assign and/or drive all aspects of clinical trial data management activities from study start-up through database lock
- Ensure the quality of all data reviewers’ deliverables
- Support and work closely with study lead data managers for assigned clinical studies
- Perform data cleaning and reconciliation activities according to company procedures and study-specific data management documents
- Manage queries on assigned clinical studies
- Generate and deliver reports to study team members
- Support external data reconciliation and serious adverse event reconciliation
- Review and reconcile laboratory data and associated lab normal ranges when applicable
- Support creation and maintenance of data management documentation, including Data Management Plans and eCRF Completion Guidelines
- Ensure data management documents are filed according to company SOPs and Work Instructions
- Support development of eCRF and edit check specifications
- Work with database builders on clinical database builds and programming of eCRFs, edit checks, and reports
- Participate in User Acceptance Testing for clinical database builds, modifications, data transfers, and programmed report outputs
- Assist with site and user management in clinical databases
- Potentially lead Phase I to Phase II studies under manager supervision
- Drive data review activities and identify and escalate potential data issues
- Work with vendors such as central laboratories on timelines and data-related deliverables
- Help identify and troubleshoot operational problems using metrics data, audit reports, and project team input
- Mentor and train study team members on eCRFs and EDC
- Support development and maintenance of data management SOPs and Work Instructions
- Perform other duties as assigned
Requirements
What you’ll need- 5+ years of experience in clinical data management in the pharmaceutical/biotechnology industry
- Oncology experience preferred
- Ability to work in cross-functional team-oriented environments
- Understanding of ICH and the regulatory environment as it pertains to data management
- Good understanding of data management and phases of clinical trials
- Strong communication skills and ability to solve issues independently
- Strong project management skills
- Excellent written, verbal, and organizational skills
- Good interpersonal skills and capability to lead study data reviewers and prioritize data management activities
- Detail-oriented
- Proficient computer skills, including Microsoft Office applications
- Working knowledge of at least one EDC system; Medidata Rave preferred
- Ability to travel domestically and internationally as required
- Bachelor’s degree or equivalent in a health-related field preferred
Benefits
Comp & perks- Annual bonus plan eligibility for Non-Commercial roles
- Incentive compensation plan eligibility for Commercial roles
- Discretionary equity awards
- Voluntary Employee Stock Purchase Plan participation
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness program