Project Manager of Clinical Data Management

Location
94061, Redwood City
Posted
Mar 06, 2018
Discipline
Clinical, Clinical Data
Required Education
Bachelors Degree
Position Type
Full time

ARMO BioSciences is seeking Project Manager of Clinical Data Management who will report to the VP Research Operations. This role will be responsible for the day-day-

Responsibilities and Job Functions

  • Provide Clinical data management support to Clinical Operations team and/or study project
  •     Participates in the review of Clinical research documents (e.g., Protocols, Case Report Forms, Reports and  Statistical analysis).
  • Develops/Reviews Data Management Plan (DMP) (validation, UAT, scripts, edit checks, issue logs etc.), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements.
  • Coordinates database lock and release of data for analyses.
  • Ensure clinical data within EDC and other databases is of quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and/or final database lock.
  • Monitors and tracks the quality of all data management deliverables ensuring audit practices have been enacted to validate the quality and assurance of database content and supporting documents, from CROs as well as other external electronic data transfers.
  • Develop study specific reports/patient profiles
  • Develop/Reviews Case Report Form (CRF), electronic and/or paper.
    • Develop ARMO CRF Library
  • Develops Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
  • Reconcile electronic data transfers from vendor to Sponsor. Coordinates and ensures smooth SAS datasets or electronic load data transfers from CROs.
  • Reviews and reconciles clinical database with external database/datasets.

Knowledge, Experience and Skills

  • Bachelors Degree Master Degree preferred
  • 5+ Years directing the design, documentation, testing and implementation of clinical data.
  • Experience Managing data management issues by reviewing protocols for cross-project consistency and identifying standard case report form modules to meet objectives

About

Being a member of the ARMO BioSciences team is a unique opportunity to make a difference in the life of patients suffering of grievous diseases.  We demonstrate a strong sense of personal ownership in everything we do and as such expect honesty, integrity, passion and scientific excellence from our employees. ARMO BioSciences is an equal opportunity employer. We are committed to building a workforce that respects individual skills and diversity and commitment to teamwork. We hire outstanding people and subscribe to a rigorous, fast-paced work ethic where the science leads the business.