The Principal Clinical Data Manager (PCDM) leads the data management components of clinical trials with demonstrated subject matter expertise in all aspects of the Data Management (DM) discipline. The CDM is responsible for ensuring study launch, conduct, and closeout are performed according to company quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations. The PCDM is responsible for overseeing the start-up, execution, and closure of Elevar clinical trials whether outsourced to CRO or in-house, to ensure data quality and integrity. The PCDM will act as a primary data management liaison with vendors and senior management. The individual will oversee and perform a variety of complex tasks to ensure complete, accurate, high quality, and regulatory compliant data in support of publications and regulatory submissions. The PCDM will report to the Head of Clinical Data Management. This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by senior data management when needed. This is a remote-based position.
· Maintain effective communication with vendors and client’s internal project team through oral and written correspondence, project status and progress reports.
· Manage the interaction with data management vendors to ensure that data management tasks remain on target according. These DM tasks include but are not limited to: protocol review to database lock to ensure data are collected, reviewed, and delivered with high quality, on-time, and within scope
· Ensure 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 oversight and support for Electronic Database Capture system 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.
· Oversight and management of cross-functional collaboration, development, and maintenance of all CDM documentation components, i.e., the study Data Management Plan (DMP) and data management deliverables including the Electronic Case Report Form (eCRF), eCRF completion guidelines, annotated CRFs, data handling plan, data review plan, edit check specifications, data transfer specifications, data quality plan, Interim/Final database lock list/approval, etc.
· Ensure that medical coding is completed in a timely fashion, completed for all data cuts, and reviewed and approved by medical monitors.
· Ensure project documentation is being archived in a timely manner into the Trial Master File
· Participate in the development of standard operating procedures (SOPs).
· Education preferences or requirements – Minimum of Bachelor’s Degree in science or health related area required
· Minimum of 10 years’ data management experience in pharmaceutical or biotechnology; prior oncology experience required
· Experience with multiple Electronic Data Capture (EDC) process and platforms such as Medidata RAVE, Medrio, etc.
· Demonstrated proficiency with ICH, GCDMP, and GCP is required
· Previous experience managing/oversight of CRO vendors
· Demonstrated problem-solving abilities and strong presentation, documentation, organizational, and interpersonal skills, as well as a team-oriented approach, are required
· Must be computer savvy and highly proficient in Microsoft Office
· High attention to details and accuracy; ability to work independently and to prioritize and organize work to meet deadlines
· 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.