Sr Clinical Project Manager- Medical Affairs

Location
Cambridge, MA, United States
Posted
Nov 29, 2018
Ref
R-00984
Hotbed
Genetown
Required Education
Associate Degree
Position Type
Full time
Title:
Sr Clinical Project Manager- Medical Affairs

Company:
Ipsen Biopharmaceuticals Inc.

Job Description:

Responsibilities will include, but are not limited to, the following:
  • Has overall oversight for a given Clinical Study from an Operations perspective
  • 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
  • Prepare 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 alignment with the therapeutic area, high quality investigators and study sites for the conduct of clinical studies
  • Review and recommend amendments to the study protocols to ensure the study feasibility and to subsequently plan and organize work schedules
  • Ensure, in conjunction with the Regulatory, Pharmacovigilance and Data Management Departments, that the necessary regulatory, safety and data evaluation requirements are met to allow the conduct of clinical related activities
  • 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
  • As applicable, manage and train CRAs, co-monitor study, review and approve site visit reports, ensuring timely and appropriate follow up of issues raised by monitors; conduct site visits as required
  • Ensure regular and timely liaison with appropriate Medical & Regulatory entities and provide regular and timely reports on all site performance changes including scope, schedules and resources; provide guidance and support to other clinical operations support staff so that the administration activity/CRA activities are carried out efficiently
  • Ensure preparation of Confidentiality Agreements and site investigational contracts according to internal Ipsen guidelines and liaise with Legal as appropriate
  • Contribute proactively to the efficient operation of the Medical Affairs Group and to systems (eDC, CTMS) and processes being planned and implemented; participate in the training on and preparation, review, updating of SOP
  • 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
  • Ensure all the tasks related to the Ipsen Electronic Data Capture (EDC) systems are completed including the training and regular support of all users including external Monitors and Site Personnel
  • Supervises and/or Performs User Acceptance Testing of the eCRF
  • Prioritize and schedule all matters related to the clinical studies
  • Chair internal and external meetings (i.e. CRA/Investigator Meetings) related to the clinical study as designated
  • Supervise the schedule of work for Medical Affairs personnel and CROs within the company
  • Manage operational activities for Investigator Sponsored Studies (ISS)
  • Complies with all laws, regulations and policies that govern the conduct of Ipsen U.S. staff


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.