Clinical Project Manager, Rare Disease

Location
Cambridge, MA, United States
Posted
Jan 01, 2021
Ref
R-06528
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time
Title:
Clinical Project Manager, Rare Disease

Company:
Clementia Pharmaceuticals USA, Inc.

Job Description:

Are you an experienced Clinical Project Manager looking for an opportunity to work on a global team focused in Rare Disease?

As Clinical Project Manager-Rare Disease, you will oversee and drive all aspects of the assigned global international clinical study(ies) outsourced to a CRO in respect of planning/timelines, quality, budget and defined goals. You will drive execution and report activities in conjunction with Clinical Development Program Directors (CDPDs), Medical Dev. Directors (MDDs), and other Ipsen team members and ensure the Global clinical studies are managed according to Good Clinical Practice (GCP), local regulations, guidelines and SOPs in the required standard of quality. Additionally, as Clinical Project Manager you will lead, manage and drive the cross-functional Clinical Study Team and Contract Research Organization (CRO) in collaboration with the CDPDs and Ipsen team members responsible of the study.

Your role will involve:

Ensuring study team management and communication
  • Oversee and drive cross-functional leadership and expertise to ensure effective contribution, execution and delivery of study activities as per quality, plan/timelines and budget for one study or more within a clinical program
  • Foster a team approach to all activities associated with the implementation, conduct and closing of clinical studies including Ipsen clinical study team members (TA, Biometry, Pharmacovigilance, Finance controlling, Global Regulatory Affairs, CMC Supply chain…) and SPs
  • Establish and maintain excellent professional relationships with Services Providers, clinical study team through regular communication, between company, investigators and experts in conjunction with Medical Dev. Director (MDD) and other relevant Ipsen team members


Lead clinical project execution
  • Lead cross-functional clinical study teams focused on conduct of assigned projects
  • Interact with CDPD to define strategic operational direction
  • Review status reports provided by Service Provider/CRO and highlight issues to facilitate decision making
  • Manage and lead all operational aspects for implementation and conduct of global clinical trial activities from study start-up to CSR, in respect of GCPs and relevant SOPs


Key accountabilities and activities
  • Set-up study team before Services Provider are on board and lead and manage regular internal Study Team meetings during the course of the study.
  • Contribute to study protocol development including study concept where applicable
  • Develop and control planning and study timelines in collaboration with all other Ipsen supportive functions/SPs
  • Provide expertise to clinical outsourcing specifications and purchasing to facilitate RFP documents and selection of Services Provider
  • Participate in the selection of Services Providers and other external vendors in collaboration with purchasing department, study team, finance controller and Corporate Legal Affairs
  • Accountable for the development, management and tracking of trial budget working closely with the finances and service provider representative - financial management of the clinical trial including budget planning and preparation of quarterly reports
  • Ensure appropriate oversight of Services Providers) and other external vendors activities and develop the oversight manual in accordance with the services providers Technical Specifications document
  • Review final draft and approve major study documents as described in the Services Providers /CROs Technical Specification documents (e.g. oversight manual, communication plan, project plan, instruction manuals….)
  • Supervise country feasibility and site selection processes in collaboration with CDPD, MDD, GMA, CRO and Ipsen Affiliates (if needed) to identify and gain approval for high quality investigators and study sites


In return, you will bring:
  • Minimum of 3 years working in clinical research with management of clinical activities for the set up and running of international registrational studies, for at least 2 years
  • Experience in managing and developing relationships with Contract Research Organizations (CROs/SPs)
  • Experience in working with multidisciplinary groups (internal & external), flexibility, adaptability and ability skills to work within a matrix environment.
  • Life science or medical graduate or other relevant qualifications.
  • English: Very good English language knowledge (oral and written)


If this sounds like an exciting opportunity to apply your clinical project management skills on our Rare Disease Clinical 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.","datePosted":"2020-12-01T00:00:00.000Z