Clinical Study Manager / Associate (Phase I/Global Trials) – Contract to Start/Top $$

Job Type: 
Clinical Research and Development
Employment Category: 
Temp To Hire

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 Clinical Study Manager, with particular strength in Phase I development, to join its R&D team.   

This position will begin as contract.  Company will pay industry-leading wage to attract and retain an excellent candidate. 

This company is building.  This CSM will focus on Phase I studies and will oversee all aspects of study design, from analysis and reporting, document creation, vendor selection and oversight, to site monitoring 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:

  • Lead the start-up, execution, and closeout of multiple Phase 1 studies (US or overseas)
  • Participate in vendor selection for clinical research units, bioanalytical laboratories, statistical support and case report forms/data management services.  Manages vendors involved in studies.
  • Generate and/or review study plans and documents (e.g. Informed Consent Forms, CRFs, Monitoring Plan and associated tools, Patient Information Sheets,) and coordinate translations as needed.
  • Lead or contribute to integrated clinical study team meetings to ensure high scientific, ethical and regulatory standards, and expeditious registration submissions worldwide
  • Works efficiently with internal regulatory, CMC, and clinical trial supplies, project management, and quality personnel to seamlessly meet key study milestones
  • Oversee study related site management and monitoring activities
  • Ensure monitoring visits are scheduled and reports submitted and finalized, provide review of monitoring visits reports
  • Contribute to or provide proactive solutions to study-related issues
  • Works to ensure TMF and other study files are kept up-to-date and inspection ready for regulatory documents

Ideal candidate will offer a related degree (BS expected) and 3+ years of clinical study management experience including site, CRO and study oversight.  Phase I experience is required.  Monitoring background and global programs experience would both be desirable.

In addition, we seek a very sharp, knowledgeable and take-charge 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.