Job Scope & Purpose:
Our long-term client is advancing an exciting pipeline of therapies for neurological disorders, with a particular focus on innovative treatments for epilepsy. They are looking for an experienced Clinical Data Management professional to join their team. There is flexibility on the leveling from Sr. Manager to Associate Director depending on experience of the incumbent who will be reporting into an experienced Director, Data Management. This individual will lead and manage data management activities for assigned programs across all phases of development, with an immediate focus on late phase studies.
Primary Job Responsibilities:
- Assist with the designing of clinical trial databases
- Oversee external data management vendors; may participate in vendor selection process
- Review protocols for cross-trial consistency and identifying standard case report form modules.
- Support creation of SDTM datasets
- Propose, draft, and maintain relevant SOPs and other policies and procedures relevant to the department
Primary Job Requirements:
- Bachelor’s degree in a scientific, medical, computer science or related field; Advanced degree preferred
- 4+ years’ data management experience in a pharma or biotech environment
- Experience in design and validating EDC databases and performing data review
- Experience in CNS or rare disease preferred
- Experience in CRO management
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