Principal Clinical Data Manager IV
- Boston, MA, United States
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.
·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.
·Competence with MS Office programs, particularly Word, Excel and PowerPoint
·Strong knowledge of current EDC technologies (e.g., Medidata Rave)
·Self-motivated, reliable team member
·Ability to communicate effectively with senior management as well as with peers
·Excellent written and verbal communication skills
·Good planning skills
·Ability to solve problems of challenging nature
·Adherence to timelines
Thursday, August 1, 2019