JGB BioPharma Consulting (Clinical Data Manager Lead)

 

Clinical Data Manager Lead

Company:
JGB BioPharma Consulting

Location:
San Francisco Bay Area, California

Contact Person:
Sage St. Clair

Phone, Email, Postal Address:
(650) 627-7652
sstclair@jgbbiopharma.com

How to Apply:
Email: sstclair@jgbbiopharma.com

# of Openings: 1

Abstract:

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).

Responsibilities:

  • – 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.

Qualifications:

  • – 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