100% remote now, but most likely will be in office 2 - 3 days per week in September. May require up to 10% travel.
A Principal Clinical Data Manager (PCDM) has a keen attention for detail and is responsible for overseeing the start-up and execution of several trials with a CRO or in-house to ensure data quality and integrity. PCDMs will independently lead multiple, high volume and extremely complex studies within a development program. The individual will perform a variety of complex tasks to ensure complete, accurate, high quality, and regulatory compliant data in support of publications and regulatory submissions.
- 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.
Join a passionate team that goes head to head with rare diseases! Great group of people to work with
- 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 WhoDrug 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.
- Requires a Bachelor’s degree in a scientific discipline or equivalent.