Clinical Trials Manager - I
A vacancy has arisen for a Clinical Trials Manager - I with an internationally renowned pharmaceutical company, based in their UK office. This organisation is known for its solid commercial portfolio of life-saving drugs within a number of therapy areas, along with a growing pipeline of investigational drugs and an unmatched patient access program. This is an exciting opportunity to work with a leading pharmaceutical organization and support their innovative impact on the healthcare field.
- Support and oversee Investigator Sponsored Trials, including Fair Market Value and feasibility assessments, contract milestone advice, and tracking and publishing follow-up as required.
- Provide operational management of Post-Authorisation Studies.
- Manage aspects of assigned international post-authorisation studies within designated program budgets and timelines.
- Develop and maintain study budgets.
- Contribute to the development of RFPs and participate in selection of CROs/vendors.
- Manage CROs/vendors for assigned post-authorisation studies.
- Communicate project status and issues and ensure project team goals are met.
- Contribute to the writing of and coordinate reviews of relevant documents, including protocols, informed consents, case report forms, monitoring plans, and clinical study reports.
- Maintain study timelines and communicate adjustments where necessary.
- Develop good working relationships with the company's US late phase operational team and cross-functional staff internationally as required.
- Participate in the preparation of interim/final clinical study reports.
- Contribute to development of abstracts, presentations, and manuscripts.
- Keep study status in Clinical Trial Management System up to date for assigned studies.
- Under supervision, may participate in or lead departmental strategic initiatives.
- Conduct study feasibility in conjunction with internal Medical Affairs and Clinical Operations staff and/or external collaborators or CROs.
- Participate in CRO calls as necessary.
- Conduct Monitoring/co-monitoring as required.
- Contribute to Clinical Operations International team activities & initiatives.
- Serve as a resource for others within the company for clinical trials management expertise.
- Works with Clinical Program Managers to manage the European component of global post-authorisation studies and/or the entire process of an EU post-authorisation study, with the ability to identify issues and adapt to changes.
- Interact with cross-functional teams internally and externally to ensure study progress.
- Serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems.
Skills and Requirements:
- Typically requires a BSc in a relevant scientific discipline.
- Typically requires relevant clinical experience in the pharmaceutical or health care industry or equivalent.
- Previous experience in the management of Phase IV and Non-Interventional studies is essential.
- Experience in the review and oversight of Investigator Sponsored Trials desirable.
- Knowledge of post-marketing requirements and different types of post-authorisation safety and efficacy studies.
- Must be able to generally understand, interpret, and explain protocol requirements to others.
- Good knowledge and understanding of ICH GCP, GVP, FDA, and EMEA regulations and guidelines applicable to post-authorization studies.
- Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
- Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Matthew Pike at +44 207 440 0639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.