Clinical Data Manager Lead
JGB BioPharma Consulting
San Francisco Bay Area, California
Sage St. Clair
Phone, Email, Postal Address:
How to Apply:
# of Openings: 1
The Clinical Data Management Lead is responsible for managing the efficient collection, processing, and review of data from clinical trials. This position serves as a technical resource in the conduct of Phase I to Phase III Clinical Trials. This person will manage one Clinical Program and may have direct reports (e.g Data Manager).
- – Directly manages CRO. Oversees the work to ensure on-time, on-target and within-budget results. May manage 1 or more Data Managers.
- – Conducts regular one-on-one and any other staff meetings to ensure timely communication.
- – Ensure consistency of classification within a study and across studies for the same compound.
- – Set global classification conventions.
- – Author study specific thesaurus management plan with classification conventions; Perform thesaurus classification of adverse events to MedDRA.
- – Understand CDISC CDASH/SDTM and clinical terminology and coding.
- – Understand EDC software and data systems such as IRT, and ePRO.
- – Perform thesaurus classification of concomitant medications to WHO drug.
- – Perform clinical data review consistency between medical history, adverse event and concomitant medication.
- – Set global lab data conventions.
- – Author study specific lab data management plan.
- – Collect local lab ranges; Assign local lab ranges to local lab data and Perform conversion of local lab data to standardized reporting units.
- – Select and oversee central labs.
- – Author external lab data management plans and specifications.
- – Receive test and production lab data transfers; Review central lab data transfers.
- – Create and maintain lab data management SOPs, work instructions and templates.
- – Perform clinical data review consistency between lab data and adverse event data.
- – Provide technical assistance to the CDM, clinical, safety, medical and biostatistics departments – Thesaurus, central lab, and local lab management.
- – Excellent oral and written communication skills.
- – Understanding and familiarity of the drug development process.<
- – Knowledge of execution of Phase I-III Clinical Trials.
- – Excellent knowledge of MedDRA and WHO drug coding dictionaries required.
- – CCDM, CDISC CDASH / SDTM standards experience preferred.
- – Basic knowledge of SAS dataset structure required, working knowledge preferred.
- – Excellent knowledge of local and central lab data required.
- – 6+ years clinical development experience required.
- – 3 years data management experience required.
- – Working knowledge of electronic data capture (EDC) processes and software.
- – Working knowledge of adverse event and concomitant medication classification processes and software.
- – Master’s Degree and 4+ years clinical development experience required; or Bachelor’s Degree and 8+ years clinical development experience required. Science degree preferred.
- – Management experience preferred.
Date Posted: 2-19-2019