Clinical Data Manager Job

Yoh has a contract opportunity for a CLINICAL DATA MANAGER to join our client in the Cambridge, MA area.

COMPANY OVERVIEW:

- Our client is dedicated to making a major positive impact on the lives of people with serious diseases.

JOB RESPONSIBILITIES:

- Act as Lead Data Manager on assigned projects; represent the organization in providing solutions to difficult technical issues associated with specific projects.
- Interact both verbally and through written communication with inter-organizational and outside customer contacts as well as with Central and External laboratories, CROs, etc.
- Contribute to the design of protocols.
- Develop eCRF specifications according to protocol and approved standards (based on industry standards), participate in user acceptance testing.
- Develop protocol specific edit check specifications and participate in user acceptance testing.
- Develop and maintain project- specific Data Management plan throughout the life cycle of the study protocol, which includes CRF annotation, database specifications, edit checks and other pertinent data management documents.
- Provide training for team members in data management procedures.
- Provide direction and coordinate data management activities to ensure timely database lock and release of data for interim and final analyses.
- Provide oversight, monitor and track quality of vendor data management deliverables, ensuring audit practices are in place to validate the quality of EDC database content as well as external electronic data transfers.
- Perform metrics on data management processes and guidelines to evaluate efficiency, accuracy, and speed in cleaning clinical study data and locking database for study reporting.
- Ensure data processing activities are performed according to protocol, GCP and SOPs.
- Participate in hands-on data review and query management as necessary.

JOB QUALIFICATIONS:

- Five (5) plus years of clinical data management experience.
- Two (2) plus years of experience with clinical database systems such as EDC (eg, Medidata Rave, Phase Forward/Oracle Inform, etc.) and IVRS are preferred.
- Thorough understanding of clinical data management methodology.
- Experience with CDISC/CDASH and standard coding dictionaries (eg, MedDRA and WHODRUG).
- Knowledge of clinical database design (either in Rave or SAS) and remote data entry technology.
- Proficiency in Microsoft Windows.

PREFERRED JOB SKILLS/EXPERIENCE/KNOWLEDGE:

- BS or BA degree in a life scientific area/technical discipline is preferred.

DISCOVER ALL THAT'S POSSIBLE WITH YOH. APPLY NOW.

RECRUITER: Natane D. Peslis

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry!

Yoh, a Day and Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: SCIENTIFIC; J2W: CLINICAL

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Ref: 985332

SFSF: REN