Job Number: 411892
Clinical Data Manager
Clinical Data Manager:
Working under the direction of a senior staff member, will fully manage assigned studies during conduct to database lock.
- Studies are outsourced to CRO and therefore this position requires the management of CRO deliverables in accordance with timelines and internal team expectations.
- It involves the accurate and timely review of documents and deliverables received from CROs such as Data Management Plans, Data Cleaning Plans, timelines, etc. Data transfers will be reviewed for data quality
- The Sr.CDC will identify study issues related to quality, timeline and adherence to standards, and communicate to supervisor
- The Sr.CDC will attend study team meetings as the data management representative and work with multiple functional areas to ensure all data management expectations are being met and help resolve any critical issues or questions
- The Sr.CDC may receive additional assignments to assist other DM staff with particular tasks such as document review or data review
- Knowledge of and experience in the discipline of clinical data management and the requirements of data coordination and GCP.
- Clear and accurate oral and written communication as well as good interpersonal skills.
- Detail oriented.
- Strong ability to multitask and produce high quality work in a fast-paced environment
- Ability to identify process issues and data discrepancies/inconsistencies
- Understanding of and experience with data standards and their implementation. Ability to understand, learn, and adapt to new processes and systems quickly.
- Technical: Microsoft Office Suite, Outlook, EDC systems, (Medidata Rave)
-RDC and RAVE.
Familiar with JReview or other tools to review clinical data
Experience working in an outsource model and managing CRO counterparts.
Summary of Work:
Candidate has at least 3 years DM experience and knowledge of DM requirements for Phase 1-3 clinical trials. Candidate has good technical and communication skills and the ability to readily learn to use new systems. Works under direction of a senior staff member with a moderate degree of independence as he/she follows established department procedures.
- Knowledge of EDC systems such as OC
Interested candidates please send resume in Word format to firstname.lastname@example.org Please reference job code 411892 when responding to this ad.