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Clinical Data Manager
The Clinical Data Management (Contractor) will support data management activities for studies across all stages of clinical drug development. They will work with the clinical study team to ensure that clinical data capture, systems and processes will ensure accurate, consistent, high quality, and complete data. The candidate will be focused primarily on a subset of clinical data management activities including (data review and query management)
Handle the development of data management documentation including CRFs, CCGs, edit check specifications, SAE reconciliation plans, Coding plans, Data Management Plans, and third-party vendor data specifications; Coordinate related reviews with cross functional team(s).
Handle and participate in UAT of clinical data management systems.
Handle and participate in clinical data review and data reconciliation.
Ensure all data management activities are being executed and tracked accordingly.
Ensure proper filing and documentation of clinical data management documents (eTMF).
Support GCP inspection readiness.
Participate in study team meetings.
Participate in departmental SOP development and process initiatives.
5+ years of clinical data management experience at Sponsor, CRO, and/or Investigative site.
Knowledge of, and experience with Microsoft applications including Word, MS Project, Powerpoint.
Knowledge of, and experience with clinical EDC systems (Medidata Rave).
Experience with J-Review, BOXI, and/or other CDM reporting tools.
Knowledge of, and experience with CDISC/CDASH standards.
Experience working with central and specialty labs/vendors.
Knowledge of medical terminology and medical coding dictionaries including MedDRA and WHO Drug.
Familiarity with GCP, ICH and FDA requirements as applicable for Clinical Data Management.
Able to manage multiple initiatives and shifting priorities within a small company environment.
Strong analytical and problem-solving skills that meet or improve the status quo.
Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment.
Excellent written and oral communication skills.
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Bachelor's or advanced degree in health-related field and/or computer science.
Experience in early phase clinical drug development including first-in-human studies.
Experience with drug development and management of data in rare genetic diseases, oncology, and CAR-T cell therapies.
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
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