Clinical Program Manager

Reference:

363950

Sector:

Account Manager, Marketing

Salary:

£80,000 to £85,000 Per Annum

Town/City:

Uxbridge

Contract Type:

Permanent

Date Posted:

13/03/2020 14:57:00

Clinical Program Manager - Late Phase

An exciting opportunity has arisen to join our leading Bio-tech client in their Clinical Operations Late Phase team based in West London as a Clinical Program Manager to be responsible for the management of post-authorisation studies, investigator sponsored research and compassionate use programs across different therapeutic areas.

Job Requirements

  • Successfully manages all aspects of assigned post-authorisation studies within designated program budgets and timelines with primary focus on studies detailed in the product Risk Management Plan.
  • Maintain current knowledge of both local & regional legislation regarding execution of post-authorisation studies.
  • Responsible for development and monitoring of study budgets and timelines and managing adjustments as necessary.
  • Actively lead Study Management Teams for assigned studies and provide strategic and operational advice as required.
  • Actively participate in CRO study calls as appropriate.
  • Conduct study feasibility in conjunction with internal Medical Affairs and Clinical Operations staff and/or external collaborators or CROs.
  • Develops RFPs, select CROs/vendors, and manages external resources.
  • Communicates project status and issues and ensure project team goals are met.
  • Anticipates moderately complex obstacles and client difficulties and implements solutions to achieve project goals.
  • Contributes to development of abstracts, presentations, and manuscripts.
  • Co-monitoring may be required.
  • Provide support to Investigator Sponsored Trials including Fair Market Value and feasibility assessment, contract milestone advice, tracking and publication follow-up as required
  • Identify any "best practice" opportunities to share across Therapeutics Areas and sites.
  • Ensure local consistency & alignment with GSI global process & procedure, whilst providing regional perspective & expertise.
  • Participate in the development of SOPs, Clinical Study Reports, INDs, NDAs, and other clinical, regulatory and safety documents as required.
  • With limited supervision may participate in or lead departmental strategic initiatives.
  • Develop good working relationships with the Global Late Phase operational team and cross-functional staff internationally as required.
  • Participate as an active member of the Global Clinical Operations Late Phase extended Leadership team and other team meetings.
  • Serve as an ambassador for Clinical Operations internally and externally.
  • Provide training to colleagues on process changes/improvements as necessary.
  • Recruit, hire, mentor, and manage direct reports as required and support their professional development.
  • Occasional travel is required.

Knowledge, Experience And Skills

  • BSc Life Sciences. A MSc or PhD would be advantageous (or international equivalent).
  • Relevant clinical experience in the pharmaceutical industry.
  • Experience in managing staff as well as mentoring and developing junior staff.
  • Experience in clinical study management including the delivery of Phase IV and non-interventional studies is essential.
  • Experience in the review and oversight of Investigator Sponsored Research.
  • Knowledge of post-marketing requirements and different types of Drug Utilisation Studies and Post Authorisation Safety and Efficacy Studies.
  • Experience in the provision of compassionate use would be beneficial.
  • Knowledge of regulatory affairs and drug safety.
  • Experience in developing RFPs and selection and management of CROs/vendors.
  • Ability to write study protocols, plans, study reports and regulatory documents (e.g. IND, DNA, etc.) with little supervision.
  • Excellent interpersonal skills, and demonstrated ability to lead is required.
  • Strong communication and influence skills and ability to create a clear sense of direction is necessary.
  • Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
  • Extensive knowledge of ICH GCP, FDA, EMEA regulations & guidelines.
  • Knowledge of drug development & commercialisation processes.
  • Functional expertise to initiate, author, or contribute to SOP development, implementation, and training.
  • Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision.

Parkside Recruitment Ltd is acting as an Employment Agency in relation to this vacancy. Parkside Recruitment is an Equal Opportunities Employer.