Clinical Trial Manager - Oncology / Cell Therapy

The Clinical Operations team is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of our clients products. For the team based in our European Headquarters in Uxbridge, we are looking for a Clinical Trial Manager to work within the Oncology Disease/Cell Therapy therapeutic area.

Essential Duties and Job Functions:
• Manages European component of global Phases II-III outsourced studies.
• 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 study budget.
• 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,
• Ensures effectiveness of site budget/contract process.
• May be asked to train CROs, vendors, investigators, and study coordinators on study requirements and cell therapy logistics.
• 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.
• May assist Clinical Operations Europe Therapeutic Area Leads 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.
• Under general supervision, is able to examine functional issues from an organizational perspective.

Specific Responsibilities:
• Works 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 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.

Essential Functions:
• 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.
• 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.
• Must be able to generally understand, interpret, and explain protocol requirements to others.
• Must be able to prioritize multiple tasks.
• Must be 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.
• Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
• Excellent teamwork, communication, decision-making and organizational skills are required.
• International travel is required (up to approximately 20%)