Clinical Study Manager, Phase I Global Trials – Contract to Start/RTP Pharma

Life Sciences
Job Type: 
Life Sciences
Clinical Research and Development
Other Life Science Positions
Employment Category: 

Our client, a growing RTP-area pharmaceutical company with marketed products as well as numerous products in development, is actively recruiting for a highly capable Phase I Clinical Study Manager to join its R&D team.   

This position will begin as a 1 year contract with the possibility of converting over to direct hire.  Company will pay industry-leading wage to attract and retain an excellent candidate. 

This company is building.  This CSM will drive global clinical development programs, with particular focus on early development.   The selected candidate with be involved in and oversee aspects of the study design and reporting, document design, vendor selection and oversight, as well as investigator selection, study conduct, site monitoring, data collection, clinical supplies and study budget development and tracking. 

We seek a versatile Study Manager whose clinical research knowledge is complemented by practiced and proven project management capabilities.  A lot is happening and we seek a candidate who thrives in a “hub” role.

Specific duties will include:

  • Oversee and manage vendors (CRO, CRAs, central laboratory, IXRS, etc.), as well as review and approve invoices
  • Contribute to Clinical Development plans and budgets
  • Coordinate and manage production of key deliverables for clinical trials, including protocols, case report forms, statistical analysis plans, data management plans and clinical study reports
  • Ensure monitoring visits and reports are meeting clinical monitoring plan expectations
  • Ensure regulatory documents and monitoring reports tracking/submissions are kept up to date
  • Generate and/or review study plans and documents
  • Ensure supplies are maintained at sites

Ideal candidate will offer a related degree (BS expected) and 5+ years of clinical study management / coordination experience including site, CRO and study oversight. Experience managing Phase I clinical studies will be required.  Global experience and Pharma side experience is desired.

In addition, we seek a very sharp, knowledgeable and organized professional who will work exceedingly well in a dynamic and collaborative setting; One who can gain the respect and cooperation of all stakeholders in order to achieve shared success.

This is an immediate need.  Please forward Word resume for prompt consideration.  Local candidates only.