Clinical Project Manager, Medical Affairs

Location
Cambridge, MA, United States
Posted
Aug 04, 2021
Ref
R-08212
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
Clinical Project Manager, Medical Affairs

Company:
Ipsen Biopharmaceuticals Inc.

Job Description:

Are you looking for an opportunity to use your clinical project management experience in a patient-focused organization?

As Clinical Project Manager (CPM) you will be responsible for studies (Phase IV and Patient Registry) conducted for Ipsen-US Medical & Regulatory Affairs with respect to: planning, implementation, coordination, reporting, and overall resource definition. The CPM ensures that clinical studies are completed according to the Protocol, Good Clinical Practice (GCP) guidelines and Ipsen's or the Contract Research Organization's (CRO) SOPs while ensuring timely delivery and budget adherence in order to assist in the delivery of US Medical & Regulatory Affairs objectives.

Your role will involve:
  • Overall responsibility for assigned Clinical Studies from an Operations perspective
  • Responsible for the direct oversight of all outsourced providers, i.e. CROs, CRAs, central laboratories, Electronic Data Capture (EDC), etc.
  • Responsible for organizing and delivering relevant Clinical Study training to other Clinical Operations / CRO staff
  • Foster and develop a team approach to all activities associated with the implementation of clinical studies; the team includes CROs' Monitors/Clinical Research Associates (CRAs
  • Establish and maintain excellent professional relationships between the company and external experts in conjunction with Project Physicians
  • Lead the feasibility and site selection processes for the Medical Affairs Studies with the support of the Ipsen Medical Science Liaisons (MSL) and CROs
  • Responsible for preparing detailed timelines and establishing clinical study milestones for assigned projects, ensuring they are performed according to the Protocol, Good Clinical Practice guidelines, and SOPs and further ensuring timely delivery and budget adherence
  • Identify, in conjunction with the medical Therapy area, high quality investigators and study sites for the conduct of clinical registration studies
  • Review and recommend amendments to the study protocols to ensure the study feasibility and to subsequently plan and organize work schedules
  • Participate in the selection of CROs and other external vendors and take responsibility for ensuring that CROs/vendors deliver in accordance with the specification, quality standard and timeframe set; manage CRO/CRA relationship as required
  • Prepare and/or manage the production of all documents necessary to implement and monitor the study in a professional, high quality and timely manner
  • Ensure preparation of confidentiality agreements and site investigational contracts according to internal Ipsen guidelines and liaise with legal as appropriate
  • Participate in the preparation and review of clinical study reports as assigned
  • Participate in the preparation and review of regulatory submission documents as needed, including IND/NDA submissions, and IND/NDA update and supplements
  • Ensure the completeness of the Clinical Trial Management Systems
  • Supervises and/or Performs User Acceptance Testing of the eCRF


In return, you will bring:
  • Bachelor's degree required, advanced degree preferred
  • Substantial relevant experience of pharmaceutical drug development including project management of domestic and international clinical studies for at least 5 years (Pharma or CROs)
  • Two or more years of experience managing Phase IV and / or Registry trials is preferred
  • Experience with expanded access programs is a plus
  • Excellent knowledge of Good Clinical Practice (GCP)/ICH regulations.
  • Experience preparing clinical study documentation.
  • Experience managing and developing relationships with Contract Research Organizations (CROs).
  • Experience compiling and managing clinical study budgets


If this sounds like an exciting opportunity to apply your clinical project management skills on our Medical Affairs Operations team, apply today!

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.