AbbVie

Program Lead I, Clinical Data Strategy and Operations, Aesthetics

Employer
AbbVie
Location
Madison, New Jersey
Posted
May 09, 2022
Ref
2208089
Required Education
Bachelors Degree
Position Type
Full time
  • Oversee the production of all Data Sciences timelines and deliverables for assigned clinical trials and all DSS-related cross-functional meetings with clinical teams, safety teams and physicians
  • Oversee all EDC,and IRT vendor contracts for assigned clinical trials
  • Supervise all Data Sciences staff (including equivalent CRO staff) for assigned clinical trials
  • Co-represent Data and Statistical Sciences at any meetings with FDA and regulatory agencies regarding assigned clinical trials
  • Lead clinical study team in the development of key clinical trial systems, study conduct and study close-out as related to Data and Statistical Sciences (DSS) operational activities. Create and manage Data Sciences communications plan for all assigned clinical trials. Exercises real, but informal authority over Data Sciences study team members’ daily tasks and timelines.
  • Manages 4 to 7 clinical trial startups concurrently
  • Plan and manage all Data Sciences timelines and deliverables for assigned clinical trials
  • Complete trial-specific Statement of Work (SoW) based on parameters supplied by Master Service Agreement (MSA) for Electronic Data Capture (EDC), electronic Patient Reported Outcomes (ePRO) and Interactive
  • Response Technology (IRT) vendors for assigned clinical trials
  • Manage and maintain vendor budgets for assigned clinical trials and process flows and data exchanges with global pharmacovigilance for clinical trial serious adverse events. Manage any internal quality assurance audit for assigned clinical trials