As part of the Data Management (DM) team, responsible for study-specific data management activities, including study set up, maintenance, data review, and database closure.
- Reviews protocols and provides input relevant to data management issues.
- Oversees/leads all data management activities for clinical studies either directly or overseeing a Clinical Research Organization (CRO).
- Manages DM study activities with vendors, including external labs (transfer specifications and timelines) and Electronic Data Capture (EDC) vendor (DB build, User Acceptance Testing (UAT), maintenance, and lock)
- Collaborates with other departments on clinical study start up (e.g. case report form (CRF) design), clean up, and closeout.
- Responsible for study-specific DM documentation including the Data Management Plan, database creation/validation including edit checks, and query generation/resolution.
- Responsible for clinical study data maintenance, data listings, entering queries, reviewing query resolutions, etc.
- Provides input on general data management documents such as SOPs and CRF templates.
BA/BS in Life Sciences or equivalent combination of relevant education and applicable job experience.
Minimum 8 years of experience in clinical data management.
- Hands on training and experience in clinical trial methodology and Good Clinical Practice.
- Excellent understanding of all aspects involved in the data management responsibilities throughout a clinical trial.
- Experience with Medidata's Rave system including strong J-Review skills.
- Proficient organizational and documentation skills.
- Excellent written and verbal communication skills.
- Strong understanding of regulatory guidance and regulations (eg. International Conference on Harmonisation (ICH), 21CFR Part 11, etc.).
- Strong understanding of CDISC and CDASH standards.
- Must be a team player who works effectively with other disciplines.