Randstad Clinical Study Management in Bridgewater, New Jersey
Clinical Study Management
Thursday, September 29, 2016
Randstad Life Sciences
Job Title: Global Feasibility Lead
The Global Feasibility Lead is accountable for the coordination and conduct of the requisite assessments associated with determining the feasibility and operational implications of clinical trials proposed or to be performed by the Clinical & Sciences Operation Platform (CSO).
The objective of the feasibility assessment is to develop recommendations utilizing wide sources of data to support protocol development and overall ability to conduct the study in a manner conducive to patient recruitment/ participation within study milestone dates.
Protocol optimization and the ability to influence decision makers towards inclusion/ exclusion criteria, study procedures, and patient friendly data collection modalities.
Ensuring that all relevant personnel are anticipating the challenges facing development programs, the Global Feasibility Lead is responsible for the operational communication of the Phase I-IV portfolio across the operational platform.
Responsible for identifying risks associated with internal competition and proposing risk mitigation strategies to positively support all programs.
The Global Feasibility Lead is also accountable for identifying protocol specific nuances to be considered when developing robust recruitment and retention strategies to enable patient participation in the study.
These high level considerations will be the responsibility of Trial Operations and CSU personnel to refine for central, local and site specific recruitment plans
At least a Master s level degree in Health Care related field or Pharmacology related sciences
Minimum of 10 years experience within the Pharmaceutical industry with a strong emphasis in clinical trial operations and / or protocol design
Experience in Clinical Development, especially relevant experience in multinational study management in a medical specialization would be appreciated.
Knowledge in ICH, GCP and local regulations.
Knowledge in Epidemiology , Project & Data Management, Clinical Site Management is strongly desired
Coordinating and leading large, multi-departmental teams
Team leadership that promotes fact based decision making
Critical thinking & problem solving
Strong Proficiency in Powerpoint, Excel & public speaking
Strong Consumer Focus and industry knowledge
Medical, Dental, and Vision Insurance
401K Plan with Company Match
Life and AD&D Insurance