Account Manager, Marketing
£80,000 to £85,000 Per Annum
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.
- 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.