RESPONSIBILITIES
- Manage all phases of data management activities and support to internal project teams, clients and Clinical Research Organization (CRO) including the following:
- Review and approve study start-up documents, Data Management Plan (DMP), Reconciliation Plan, Quality Control Plan, Coding Plan, Validation Plan, Communication Plan and other documentation as required.
- Supervise data cleaning activities including processing Data Clarification Form (DCF)/query tracking and conducting and orchestrate scheduled cross-functional data review/reconciliation, identification of issues and track through resolution Design and/or approve final Electronic Case Report Form (eCRF)/Case Report Form (CRF), edit check specifications, case report form guidelines and electronic data handling conventions
- Manage database build activities, database validation and review and execution of User Acceptance Testing of clinical databases
- Facilitate internal study team, client and CRO meetings
- Actively review and provide feedback on study data quality including providing data management metrics, review project statement of work and identify and report to manager any requested out of scope activities
- Assist manager in monitoring timelines and managing resources to meet timelines
- Direct team members in daily activities including training and supervising Clinical Data Managers I and II
KNOWLEDGE & SKILL REQUIREMENTS
- 10 years data management experience, or B.S./B.A. in a science or technical discipline degree with 6 years data management experience, or MS degree with 4 years data management experience; minimum 4 years in the Pharmaceutical/Biotechnology industry or CRO environment
- Meet the requirements of a Sr. Clinical Data Manager with a high degree of proficiency and autonomy
- Ability to program in SQL or SAS desirable, but not required
- Experience with various data collection and Electronic Data Capture (EDC) systems and related tools and processes
- Excellent oral and written communication skills
- Ability to work in a collaborative and multi-disciplinary environment