Manager, Data Management

Pharmica Consulting - Princeton, NJ

Manager, Data Management

 

Position Summary:

Maintain a project-level perspective on data management issues, activities and deliverables. Oversee the Contract Research Organization (CRO) and third-party vendor processes involved in developing data collection systems, data cleaning and providing data deliverables conforming to global CDISC standards. Provide strategic input into protocol design from a data management perspective. Represent the Data Management Department on project teams and manages flow of data from collection to submission. Work with representatives from all functional areas to develop and maintain consistency, accuracy and quality of data across therapeutic areas.

 

Key Job Responsibilities-

  • Works collaboratively with CROs and third-party vendors to design database, define quality specs, and resolve data management-related issues.
  • Assists in developing and maintaining DM standards and processes for both in-house and CRO studies in accordance with applicable standard operating procedures (SOPs) and GCPs.
  • Provides consultation, leadership, and expertise to CRO DM and project teams on Data Management functions.
  • Acts as the Data Management lead for all assigned protocols, including contributing to the development and implementation of project plan.
  • Ensure standard processes are followed by all CROs for data management activities. Train CRO personnel on current processes.
  • Uses software applications to monitor and evaluate CRO performance (e.g. query status, data trends, detecting outliers and study progress)
  • Acts as a resource to the contract staff to identify problems and propose solutions to maintain projects within designated timelines.
  • Proactively identifies and implements opportunities for process improvements.
  • Provides expert review and help in the development of CRF/eCRF/eSource design specifications, validation specifications and report design, etc. Works with external service providers to help troubleshoot and resolve problems.
  • Ensures the consistency of CRF design and coding across studies and programs.
  • Contributes to protocols, clinical study reports, Investigator Brochures, Statistical Analysis Plans, INDs and other regulatory documents.
  • Prepares submission ready Electronic Case Report Forms (eCRFs) to support electronic submissions.
  • Reviews SOW, provides input and ensures consistency across programs for Data Management activities to be outsourced to CROs.
  • Manages third party vendors’ (e.g., CROs, EDC/eSource, and ancillary) processes, and local/central laboratories on defined data standards, content specifications, and timelines for deliverables.
  • Communicates and interacts with CRO vendors to ensure that project timelines are met with quality.
  • Provides status reports on the progress of projects/programs to internal team.
  • Ensures data management related presentations for Investigator’s meetings adhere to Otsuka requirements.
  • Provides input in the development of departmental and global SOPs.
  • Serves as project team member and works closely with biostatistician and programmer to provide quality deliverables.
  • Other tasks assigned by Associate Director, Director or Sr. Director of Data Management

 

Requirements-

  • Bachelor’s degree with a minimum of 6+ years of experience in data management, as well as pharmaceutical industry experience.
  • Strong understanding of medical concepts and terminology
  • Knowledge of CDISC and industry standards
  • Strong working knowledge of data management practices and applicable global regulatory requirements
  • Strong working knowledge of electronic data capture systems, eSource and familiarity with regulatory guidelines on use of electronic systems.
  • Strong computer skills with demonstrated experience in working with the Microsoft suite of programs.
  • Know how/when to apply organizational policy or procedures to a variety of situations.
  • Strong oral and written communication/presentation skills.

 

 

 



Posted On: Thursday, September 23, 2021



Apply to this job