Clinical Trials Manager II

Hobson Prior are currently looking for a Clinical Trials Manager II to join a research-based biopharmaceutical company. Our client is very patient-focused, whose scientific research has benefitted hundreds of thousands of people by ensuring medications are available to those who could otherwise not afford them. This is a contract role located in Uxbridge.

Job Responsibilities:

• Accountable to manage European component of global Phases II-III outsourced studies.
• Contributes to development of study budget.
• Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.
• Maintains study timelines.
• Contributes to development of RFPs and participate in selection of CROs/vendors.
• Manages CROs/vendors.
• Coordinates review of data listings and preparation of interim/final clinical study reports.
• May contribute to development of abstracts, presentations, and manuscripts,
• You will ensure effectiveness of site budget/contract process.
• May be asked to train CROs, vendors, investigators, and study coordinators on study requirements and cell therapy logistics.
• Any other assigned tasks.

Key Skills:

• Ability 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.
• Strong teamwork, communication, decision-making and organizational skills are required.
• Ability to generally understand, interpret, and explain protocol requirements to others.

Requirements:

• Oncology/Cell Therapy experience is essential for cell therapy and desirable for oncology.
• Must have multinational (preferably EU) clinical trials experience including study management/coordination.
• Previous monitoring experience highly desirable as site oversight monitoring visits will be required.
• Thorough knowledge and understanding of FDA and EU Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
• International travel is required (up to approximately 20%)
• Must have a general, functional expertise to support SOP development and implementation.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.