Clinical Trial Manager (CTM)

Описание вакансии

The Position

Careers within the Clinical Operations team offers individuals the opportunity to develop their knowledge & experience rapidly whilst enjoying a supportive and team-focused working environment. Kite and Gilead’s operational model allows each Clinical Operations professional to make a genuine impact on the business and ultimately our ability to deliver live changing therapeutics to those in need.

An exciting and challenging opportunity has arisen to join the European Headquarters based in Stockley Park, Uxbridge as a Clinical Trial Manager to be responsible for the management of European and/or global activities on assigned study(ies) within the Cell Therapy Area. This role is Hybrid and requires 3 days per week at our Uxbridge offices

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.
• 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. There might also be scope for global trial management.
• 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 highly preferable.
• 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%)
• 3 days per week at Stockley Park

Gilead/Kite Core Values

INTEGRITY – Doing What’s Right

INCLUSION – Encouraging Diversity

TEAMWORK – Working Together

EXCELLENCE – Being Your Best

ACCOUNTABILITY – Taking Personal Responsibility