Responsibilities 

  • Be accountable for the project management, oversight and timely delivery of clinical trial data and documentation to relevant industry data standards and according to agreed timelines, budget and quality requirements.
  • Plan and track content, format, quality, and timing of data management deliverables, including, but not limited to, eCRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival; ensures deliverables are on time and within budget.
  • Act as the main liaison between the clinical study team, the vendor and other functional partners for all issues related to data for assigned CAR T clinical trials.
  • Plan and manage data management aspects of global clinical trials through management and oversight of outsourced data management staff.
  • Be responsible for Inspection Readiness of all data management.
  • Be responsible for maintaining oversight on outsourcing supplier contracts in line with the role.
  • Create and report data management updates to management on a regular basis; report on performance to plan.
  • Ensure clean and valid clinical study data for delivery to clinical study teams and subsequent analysis.  
  • As a functional lead on the clinical study team, ensures timely study start up and database availability.
Background:
  • The successful candidate should hold a degree in a scientific discipline.
  • Proven experience of working with a Pharmaceutical/CRO/Biotechnology organisation, as Clinical Data Manager.
  • Experience in vendor oversight.
  • Good submissions experience.
  • Relevant professional experience in an Oncology clinical trials environment.
  • Ideally worked in both CRO and sponsor data management positions