Description
The Manager, Clinical Data Management manages the activities of Clinical Data Management team members as well as study deliverables. He or she conducts study start-up activities, including CRF design and edit check development, leads a team in the effort to maintain a study through its data cleaning process, and finalizes a database to its lock, all in compliance with GCP regulations and Medivation operating procedures.Essential Duties & Responsibilities but not limited to the following:
- Manage and coordinate the activities of internal team and external vendors
- Plan, organize, and coordinate global data management activities on both a study basis, and across studies
- Work with urgency and high level of attention to detail
- Identify issues and create training tools for site and field staff
- Participate in internal study team meetings as well as teleconferences with outside vendors and study personnel; update the teams on study metrics and provide ad hoc training
- Mentor junior staff reporting to the Manager
Requirements:
- Seven (7) to 10 years experience in clinical data management at a biotechnology or CRO company.
- Prior management experience over junior clinical data managers or coordinators
- Knowledge of FDA, EMEA, and ICH guidelines and regulations covering clinical trials, statistics, and data management
- Awareness/experience in the use of data standards (CDISC, CDASH, HL7) in the clinical trial environment
Education
- B.S. or B.A. required.
To find out more about Real please visit www.realstaffing.com