Principal Clinical Data Manager

• Serve as lead CDM on assigned clinical trials by attending internal and external clinical trial project team meetings.
• Responsible for the study-specific data management tasks from protocol review to database lock to ensure data are collected, reviewed, and delivered with high quality, on-time, and within scope.
• Responsible for the accurate development of CRFs and edit specification per protocol and the completeness of user acceptance testing of CRFs and associated edit specifications for assigned clinical trials.
• Provide ongoing operational support for Medidata RAVE activities during clinical trial conduct including development of clinical databases and associated external data transfer documents including import/export agreements and data specifications.
• Provide ad-hoc report development, and support database lock and archiving activities.
• Review and contribute as a member of the CRF development team to develop the data collection modules on assigned studies where protocol requirements are outside of standard CRF library versions.
• Ensure that medical coding is completed in a timely fashion, completed for all data cuts, and reviewed and approved by medical monitors.
• Participate in the development of standard operating procedures (SOPs).
• Mentor junior staff on clinical data management activities and procedures.
• Provide guidance to clinical data management personnel on assigned projects, reviewing study documents as needed, e.g. Data Management Plan, Operational Plan for database locks.
• Ensure project documentation is being archived in a timely manner into the Trial Master File.
• Independently monitor own activities and project status for successful project deliverables according to timelines.
• May lead or participate in initiatives to streamline data management processes.

Requirements:

• Experience in clinical data management for 7+years.
• Experience in vendor management of outsourced studies.
• Demonstrate strong medical terminology skills.
• Experience defining, entering, processing, reviewing, and validating clinical data; and understanding and following clinical trial protocols and data collection documents.
• Medidata Rave experience required.
• Medidata Suite products (Safety Gateway, ePRO, RTSM) preferred.
• Experience with CDASH terminology and/or MedDRA and Who Drug medical coding preferred.
• Possess effective written and verbal communication skills, interact professionally with personnel at all levels within and external to the company,and be dependable and a team player.
• Demonstrate initiative, sound judgment and flexibility; possess effective time management and organizational skills; and be capable of working under deadlines.
• Capable of working on multiple projects simultaneously, independently manage responsibilities according to deadlines, and define tracking tools to manage projects.
• Experience in solving extremely complex and increasingly difficult problems, taking appropriate corrective action, and identify and implement improvements.
• Possess a thorough knowledge of Data Management SOPs and regulatory requirements and be capable of providing guidance to and training peers.