Clinical Trial Manager

Hobson Prior is currently recruiting for two Clinical Trial Manager positions (Oncology/Cell Therapy and Inflammation) based in Uxbridge. This is an exciting opportunity to join the Clinical Operations team at a thriving research-based pharmaceutical company.

Job Responsibilities:

• Co-operates with Clinical Program Managers and Global Clinical Trial Leads to manage the European component of global clinical trials and/or the entire process of a local clinical trial, with the ability to identify and resolve issues.
• Communicates with cross-functional teams internally and externally to ensure trial progress.
• Incorporate study logistics and planning to accomplish study objectives.
• Leads European component of global Phases II-III outsourced studies.
• Be 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 RFPs and participate in selection of CROs/vendors.
• Manages CROs/vendors.
• Organises review of data listings and preparation of interim/final clinical study reports.
• May assist in the development of abstracts, presentations, and manuscripts.
• Ensures effectiveness of site budget/contract process.
• Conducts oversight monitoring visits as required.
• Assists in determining the activities to support a project’s priorities within functional area.
• Coordinates and supervises all aspects of a clinical study.
• Under supervision, may design scientific communications within the company.
• Contributes to Clinical Operations Europe team activities & initiatives.
• Under general supervision, can examine functional issues from an organizational perspective.

Key Skills:

• Be able to prioritize multiple tasks. 
• Teamwork player, communication, decision-making and organizational skills are required.

Requirements:

• Oncology/Cell Therapy experience is essential for cell therapy and desirable for oncology. 
• multinational (preferably EU) clinical trials experience including study management/coordination is essential.
• Monitoring experience due to site oversight monitoring visits will be required. 
• In-depth knowledge and understanding of FDA and EU Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable. 
• Must be able to generally understand, interpret, and explain protocol requirements to others. 
• Able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision. 
• Must have a general, functional expertise to support SOP development and implementation. 
• Capable of resolving problems using national and international regulations, guidelines, and investigator interaction. 
• International travel is required.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back 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.