Manager, Clinical Data Management
New
J
JobgetherClinical trials
Based in the United StatesContractManager
Salary50 - 80 USD per hour
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Job Details
- Experience
- 4–8+ years of experience in Clinical Data Management or a related Data Management discipline.
- Required Skills
- Microsoft Excel
Requirements
- Have a bachelor’s or master’s degree.
- Have 4–8+ years of experience in Clinical Data Management or a related Data Management discipline.
- Demonstrate experience managing CROs and Data Management vendors; global or cross-cultural experience is preferred.
- Understand the drug development lifecycle and clinical data management processes.
- Know pharmaceutical industry guidelines, Good Clinical Practice (GCP), 21 CFR requirements, and applicable global regulatory standards.
- Be familiar with Electronic Data Capture (EDC) systems.
- Have general proficiency with Microsoft Word, Excel, and Project.
- Know clinical data coding and related data management practices.
- Be able to manage multiple studies, processes, and competing priorities under tight timelines.
- Demonstrate stakeholder and relationship management, negotiation, analytical, and problem-solving capabilities.
- Be comfortable working independently with minimal supervision in a fast-paced environment.
- Oncology clinical study experience is a plus.
Responsibilities
- Serve as the primary Data Management contact for assigned clinical studies and collaborate with cross-functional teams and external vendors.
- Manage CROs and Data Management vendors, including priorities, project plans, scopes, timelines, deliverables, and changes.
- Act as a Data Management Subject Matter Expert from protocol review through database lock and study closeout.
- Develop and execute Data Management project plans covering milestones, quality control, database setup, study conduct, and closeout.
- Oversee vendor deliverable quality and timeliness and ensure work meets Data Management standards and requirements.
- Monitor vendor performance, identify risks or issues, and escalate concerns when appropriate.
- Communicate project status, quality metrics, timelines, and vendor performance to stakeholders and develop mitigation or action plans.
- Review protocols and study documentation to ensure Data Management requirements are addressed.
- Ensure Data Management standards, procedures, and SOPs are followed across assigned studies.
- Identify and resolve data management challenges while maintaining accountability for study milestones and deliverables.
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