Associate Director, Data Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Direct a team of data managers to guarantee high-quality outcomes from the initiation to the conclusion of Phase II to Phase IV global clinical trials.

• Oversee data management tasks for clinical trials at both the study and program levels, including providing direct supervision for trial(s).

• Create and update Data Management documentation.

• Set and manage timelines and resources for the completion of data management deliverables.

• Collaborate across functions to create and evaluate initiatives, data standards, and SOP/SWP documents & Metrics.

• Organize and engage in meetings within the data management team to ensure uniformity of data management practices across various trials.

• Aid in the creation of company process initiatives and best practices/SOPs within Eisai DM.

⛳️ Requirements

• A Bachelor's or advanced degree in sciences or a related area.

• Over 10 years of clinical data management experience in the pharmaceutical/biotech sector.

• Alternatively, a combination of equivalent education and experience.

• Demonstrated knowledge of Project Management principles, with PMP certification preferred.

• CCDM or comparable certification with experience in CDISC/SDTM preferred.

• Proficient in tracking and managing clinical data management budgets, as well as contract and vendor management and regulatory submissions.

• Experience in direct people management or through matrixed relationships is preferred.

• Extensive experience in managing CROs and BPOs.

• Demonstrated expertise and understanding of clinical research, GCP, SOPs, regulatory obligations, and effective data management practices.

• Strong background in clinical data management systems and best practices is preferred.

• Experience in mentoring and training team members (including external/contract staff) on clinical data management procedures and activities.

🏝️ Benefits

• Eisai Inc. Annual Incentive Plan.

• Eisai Inc. Long Term Incentive Plan.

• Company employee benefit programs.