Associate Director, Data Management
About The Position
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Associate Director of Data Management leads 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, according to SOPs and guidelines. This role has leadership of the data management group including performance management, training and mentorship; capacity planning; supervision of timelines and contingency planning. The AD also leads process improvements initiatives and provides leadership during audits and inspections. The AD also leads and participates closely with other functions to implement new technologies and tools. AD stays current with industry standards and trends related to Data Management activities and ensure that processes are aligned.
Requirements
- Bachelors or advanced degree in sciences or related field with 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.
- Proven performance in earlier role.
Nice To Haves
- PMP certification preferred
- CCDM or equivalent certification with experience with CDISC/SDTM preferred
- Experience managing people directly or through matrixed relationships preferred
- Strong experience with clinical data management systems and best practices preferred
Responsibilities
- Responsible for the selection, oversight and performance of suitable vendors for the outsourcing of DM activities and for building effective DM vendor relationships, including identification and assessment of KPIs.
- 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.
- Lead and/or participate in the development of clinical standard libraries, Data Validation Specifications, Data Management Plan, and other standard Data Management documents, tools, and templates.
- Establish and manage timelines & resources for delivery of data management deliverables for assigned studies.
- Collaborate cross functionally to develop and review of initiatives, data standards and SOP/SWP documents & Metrics.
- Ensure data management activities are conducted in accordance with internal SOPs, industry standards, and regulatory requirements.
- 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, aligned with industry and regulatory best practices.
- Manage data management team(s) including training & mentoring, communicating expectations and performance evaluation.
Benefits
- Eisai Inc. Annual Incentive Plan
- Eisai Inc. Long Term Incentive Plan
- Company employee benefit programs
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What This Job Offers
Job Type
Full-time
Career Level
Manager
