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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.
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
clinical data managementdata management documentsproject managementCDISCSDTMclinical data management systemsbudget managementcontract managementvendor managementregulatory filings
Soft Skills
leadershipcollaborationmentoringtrainingcommunicationorganizational skillsoversightproblem-solvingteam managementcross-functional collaboration
Certifications & Qualifications
PMPCCDM
Industry Keywords
clinical trialsGCPSOPsregulatory requirementsbest practicesCROsBPOsdata standardsmetricsprocess initiatives
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