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Clinical Project Manager - France, United States  

Company managed [?] Still accepting applications

Posted on : 08 May 2017

Project Description

Description:
  • The Clinical Project Manager is responsible for providing customer-focused leadership and project oversight. 
  • This position facilitates communication among team members, including study monitors, sponsor personnel and the company  Project Team.
  •  The Clinical Project Manager proactively solves issues, and oversees the successful implementation and monitoring of clinical studies to ensure that studies are conducted in accordance with ICH/GCP and applicable regulations.



Responsibilities:
Under the supervision of the Head of Clinical Operations, duties and responsibilities relative to the management of Clinical Research studies will include, but will not be limited to:
  • Manage and coordinate the activities of clinical trials with the company Project Team. 
  • Serve as the main point of contact and communicate with sponsors regarding project timelines, updates, needs and emerging issues. 
  • Develop study timelines based on protocols. 
  • Ensure project start-up activities by facilitating processes for preparation of regulatory documents, ensuring timely IRB approvals for clinical trials. 
  • Lead the internal project meetings including Kick-off meetings and Study Initiation meetings, etc. with sponsors/internal teams. 
  • Follow screening and recruitment activities to ensure timely enrollment in the studies.  
  • Organize and coordinate Safety Review Meetings with Investigator / sub-investigator / Medical and scientific affair members. 
  • Monitor and ensure that project scope and deliverables are fulfilled within timelines and budget. 
  • Support and coordinate with the Biometrics team to ensure completion of the Clinical Study Report, as applicable. 
  • Review and manage study contracts/budgets. Collaborate with Billing and Accounts Department to ensure billing is in agreement with pre-established milestones. 
  • Review and approve Vendor/Site contracts, budgets and invoices. 
  • Regularly and in a timely fashion, interact with management, sponsors, and/or functional team members on matters concerning resource allocation, project milestones, regulatory issues, and other relevant issues. 
  • Organize sponsors' visit of the Unit (Site qualification visits, Initiation Meetings, Monitoring visits and Close-out visits) 
  • Occasional travel may be required for bid defense, initiation or kick-off meetings, or other study-related activities. 



Requirements:
  • Requires a Bachelor's degree (Masters a plus) in life sciences or related field. 
  • Minimum 3-5 years of experience in clinical research and knowledge of GCP and FDA regulatory requirements is required. 
  • Good understanding of the drug development process. 
  • Must have previous experience managing projects and in monitoring clinical studies. 
  • Excellent written and verbal communication skills, as well as interpersonal skills. 
  • Exceptional time management and conflict resolution skills required. 
  • Ability to interact with all levels of management, sponsor and study site personnel. 
  • Detail-oriented and possess good trouble-shooting skills with the ability to prioritize and execute tasks in a high-pressure environment. 
  • CCRC certification preferred. 
  • Proficient computer skills in Microsoft Office Suite.