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Associate Director of Clinical Data Management

Associate Director of Clinical Data Management

CompanyRecursion Pharmaceuticals
LocationSalt Lake City, UT, USA, London, UK, Toronto, ON, Canada, Oxford, UK, New York, NY, USA
Salary$189000 – $244000
TypeFull-Time
DegreesBachelor’s
Experience LevelExpert or higher

Requirements

  • Bachelor’s degree in science, math or computer science
  • 12+ years’ experience in the biopharmaceutical industry
  • Experience managing external data and 3rd party vendors
  • Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials
  • Excellent written and verbal communication skills and ability to work collaboratively as a part of a team.

Responsibilities

  • Lead End to End Data Management activities with hands on ability to manage outsourced studies and lead DM and external vendor oversight activities and deliverables.
  • Represent Data Management function in Clinical Study Meetings, ensuring proactive alignment of expectations between the CRO and Recursion regarding all data-related deliverables.
  • Work with CRO and Recursion functional groups to complete EDC set up and other systems such as IRT, ePRO etc.,
  • Establish Vendor Oversight Plans for all studies and responsible for Vendor Data Quality Reviews and Oversight.
  • Serve as a SME for various operational activities and DM processes like EDC, External data standardization, Collection, and Processing.
  • Lead/Oversee the creation and maintenance of Data Management documents including, but not limited to, CDMP, CCG’s, Data Review Plans, edit checks, Listing review checks, Data Integrations specs, Data Transfer Specs, External Data Reconciliation plans, SAE Reconciliation Guidelines, Coding Guidelines, Database Lock, Checklists and Plans.
  • Coordinate with vendors to guarantee that data collection is compatible with clinical databases and meets SDTM requirements.
  • Accountable for coordination with other functional groups for submission related activities.
  • Manage strategic input into the design of data flow across EDC and non-EDC data sources across vendor networks.
  • Ensure filing, archival and inspection readiness of all Data Management Trial Master File (TMF) activities.
  • Review and manage external Data Management Budgets, ensure accuracy, and understand trends to support Budget planning and forecasting.
  • Support the development of Clinical Data Management Standard Operating Procedures and Work Instructions.
  • Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and CDM guidance documents.

Preferred Qualifications

    No preferred qualifications provided.