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Associate Director, Data Management
CisionAssociate Director leading data management for Phase II to IV clinical trials in the pharmaceutical sector. Overseeing a team, ensuring quality deliverables and compliance with industry standards.
Tech Stack
Tools & technologiesGoogle Cloud PlatformPMP
About the role
Key responsibilities & impact- Lead a team of data managers to ensure high quality deliverables from Study start up to Study close down for Phase II to Phase IV global clinical trials
- Manage data management activities of clinical trials at a study/program level including providing direct oversight of a trial/s
- Author and maintain Data Management documents
- Establish and manage timelines & resources for delivery of data management deliverables
- Collaborate cross functionally to develop and review of initiatives, data standards and SOP/SWP documents & Metrics
- Plan and participate in meetings within the data management group to ensure consistency of data management practices across trials
- Contribute to the development of company process initiatives, best practices/SOPs within Eisai DM
Requirements
What you’ll need- Bachelors or advanced degree in sciences or related field
- 10+ years of clinical data management experience in pharma/ biotech industry
- OR a combination of equivalent education and experience
- Proven experience with Project Management principles and/or PMP certification preferred
- CCDM or equivalent certification with experience with CDISC/SDTM preferred
- Experience tracking & managing clinical data management budgets, contract & vendor management and regulatory filings
- Experience managing people directly or through matrixed relationships preferred
- Extensive experience managing CROs and BPOs
- Proven experience and knowledge of clinical research, GCP, SOPs, regulatory requirements and good data management practices
- Strong experience with clinical data management systems and best practices preferred
- Experience mentoring and training team members (external/contract staff) on clinical data management activities and procedures.
Benefits
Comp & perks- Eisai Inc. Annual Incentive Plan
- Eisai Inc. Long Term Incentive Plan
- Company employee benefit programs
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical data managementdata management documentsproject managementCDISCSDTMclinical data management systemsbudget managementcontract managementvendor managementregulatory filings
Soft Skills
leadershipcollaborationmentoringtrainingcommunicationorganizational skillsoversightproblem-solvingteam managementcross-functional collaboration
Certifications
PMPCCDM