Clinical Trial Manager

Location
Somerville, NJ
Posted
Apr 28, 2017
Institution Type
Outside Academe


Job Description

SUMMARY:

The Clinical Trial Project Manager is responsible for the overall management and oversight of phase I-III clinical trials from start up through CSR, including but not limited to: development of project documentation, training project staff, monitoring study progress, assessing protocol adherence, administration and oversight of study budgets, management of third-party vendors for clinical services, management of project timelines and deliverables. Reporting to the Sr. Director, Clinical Operations, the Clinical Trial Project Manager will be assigned responsibility for managing individual studies and the staff assigned to them, as well as participating in development and review of department Standard Operating Procedures (SOPs) and process improvement initiatives.

RESPONSIBILITIES:
  • Manage assigned clinical studies in compliance with corporate SOPs and relevant regulations with high quality and within the study timelines and budget
  • Effectively manage the cross-functional study team through information-sharing, ongoing study team meetings/discussions and ensuring effective risk management planning
  • Oversee and track progress of site identification, start-up, monitoring, and study close-out activities, including managing third-party vendors
  • Manage projects in accordance with contracts, proactively recognizing changes in scope and collaborating with senior management to ensure timely completion of change orders
  • Monitor metrics to ensure quality and performance standards are met by vendors and assigned project staff
  • Develop and maintain detailed project plans, and oversee the maintenance of the internal project Trial Master File
  • Provide coaching/mentoring to assigned project staff (Clinical Research Associates and Clinical Trial Associates) by demonstrating leadership competencies
  • Proactively identify potential resource needs to management
  • Provide regular updates on study status to senior management
  • Participate in staff recruitment activities
  • Participate in the development and review of SOPs and process improvement initiatives as requested

Qualifications
  • Requires a Bachelor's degree in the life sciences, healthcare or related field
  • 7+ years of clinical trial management experience within the pharmaceutical/biotechnology industry managing the logistics of clinical trial execution
  • Experience managing large and/or complex studies and project teams is preferred
  • Experience in pulmonary/respiratory indications is preferred
  • Demonstrated experience managing CROs and other specialty vendors is essential
  • Thorough understanding of the drug development process and clinical trial execution, including ICH/GCP requirements and local regulations
  • This position requires approximately 20% business travel, both domestic and international



Somerville, NJ

e4e65a4714

Thu, 20 Apr 2017 14:43:51 PDT

PI97648679