Contract Clinical Trial Manager
A vacancy has arisen for a Human Resources Assistant with an internationally renowned pharmaceutical company, based in their London office. This organization 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.
- Manages global outsourced studies managed by an EU-based Clinical Program Manager.
- Maintains study timelines.
- Manages CROs/vendors.
- Coordinates review of data listings and preparation of interim/final clinical study reports.
- Ensures effectiveness of site budget/contract process.
- Conducts Monitoring/co-monitoring as required.
- Assists in determining the activities to support a project's priorities within functional area.
- Assists Clinical Operations Europe Therapeutic Area Lead in their duties
- Contributes to Clinical Operations Europe team activities & initiatives
- May serve as a resource for others within the company for clinical trials management expertise.
- Works with Clinical Program Managers to identify issues and adapt to changes.
- Interacts with cross-functional teams internally and externally to ensure trial progress.
- Will incorporate study logistics and planning to accomplish study objectives.
- Will serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems.
- Drafts and coordinates review of relevant documents including protocols, informed consents; case report forms, monitoring plans, investigator brochures, and clinical study reports.
- Contributes to development of study budget.
- Contributes to development of RFPs and participate in selection of CROs/vendors.
- May be asked to train CROs, vendors, investigators, and study coordinators on study requirements.
- Coordinates and supervises all aspects of a clinical study.
- Under supervision, may design scientific communications within the company.
- Under general supervision, is able to examine functional issues from an organizational perspective.
Skills and Requirements:
- Requires either a BSc/ BA (in a relevant scientific discipline) or a RN qualification.
- Therapeutic area (Oncology) experience preferred however not essential.
- Additional European language would be beneficial but not essential.
- Must have solid previous study management/coordination experience.
- Hands on experience of actively setting up and running clinical trial sites across multiple areas.
- Demonstrated project management skills.
- 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 is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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