Senior Manager/ AD, Clinical Data Management
Greater Boston area
- Manage all aspects of the clinical data management process from study start-up to database lock for in-house Electronic Data Capture (EDC) trials including data management performance, metrics, quality assurance checks and communication of trial status within and outside the trial team
- Manages team of data managers; defines resource requirements, priorities and staffing assignments
- Responsible for the quality of the data in each database, as well as quality of other data management deliverables
- Develops/leads the creation and archival of data management documents and deliverables such as Case Report Forms, UAT Plan, Data Management Plan and Integrated Data Review Plan.
- Liaises with CROs, EDC vendors and other third-party vendors in a project-manager capacity in support of timelines and data-related deliverables.
- Participates in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities
- Support deliverables supporting the reporting requirements under the Investigational New Drug (IND) application (e.g., IND, Annual Report, Clinical Study Report, and NDA)
Skills, Education and Experience:
- BS/BA in a life science or analytical area.
- 7+ years data management experience in pharmaceutical research or health related field.
- Advanced knowledge in medical terminology, medical coding (MedDRA and WHODrug Dictionaries)
- Demonstrated success in project or task force leadership roles.
- Medidata Rave EDC experience is preferred.
- Experience in performing data management in Oncology indications
- Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment
THIRD PARTY AGENCIES, SUBCONTRACTORS, AND RECRUITERS NEED NOT APPLY. Applicants received from firms will not be considered. Subcontracting is not available for this position.