Job Title: Clinical Trial Manager – Cell Therapy (Europe)
Job Description
This role is based at our European Headquarters in the UK and is responsible for managing the European component of global and local clinical trials within the Cell Therapy area. The Clinical Trial Manager works closely with Clinical Program Managers and Global Clinical Trial Leads, interacts with cross‑functional teams, and serves as the primary point of contact for Contract Research Organisations (CROs) on site oversight and data deliverables.
Essential Duties and Job Functions
* Manages the European component of global Phase I‑III outsourced studies.
* Drafts and coordinates the review of protocols, informed consents, case report forms, monitoring plans, investigator brochures, and clinical study reports.
* Maintains study timelines.
* Contributes to development of study budget, RFPs and vendor selection.
* Manages CROs/vendors and coordinates review of data listings and preparation of interim/final study reports.
* Contributes to the preparation of abstracts, presentations, and manuscripts.
* Ensures effectiveness of site budget/contract process.
* Trains CROs, vendors, investigators, and study coordinators on study requirements and cell‑therapy logistics.
* Conducts oversight monitoring visits as required.
* Assists in determining activities to support project priorities within the functional area.
* Coordinates and supervises all aspects of a clinical study.
* Under general supervision, designs scientific communications within the company.
* Contributes to Clinical Operations Europe team activities and initiatives.
* Serves as a resource for clinical‑trials management expertise within the company.
* Examines functional issues from an organizational perspective under general supervision.
Specific Responsibilities
* Collaborates with Clinical Program Managers and Global Clinical Trial Leads to manage the European component of global trials and/or the entire process of a local trial, identifying issues and adapting to changes.
* Interacts with cross‑functional teams internally and externally to ensure trial progress.
* Integrates study logistics and planning to accomplish study objectives.
* Serves as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems.
Essential Functions
* Oncology/Cell Therapy experience highly preferable.
* Experience in multinational (preferably EU) clinical trials, including study management and coordination.
* Monitoring experience highly desirable.
* Thorough knowledge of FDA and EU regulations, ICH guidelines, and GCPs governing clinical trials.
* Ability to understand, interpret, and explain protocol requirements.
* Strong prioritisation skills and ability to manage multiple tasks.
* Capability to participate in multiple departmental or inter‑departmental initiatives under limited supervision.
* Functional expertise to support SOP development and implementation.
* Problem‑solving skills using national and international regulations, guidelines, and investigator interaction.
* Excellent teamwork, communication, decision‑making, and organisational skills.
* International travel may be required.
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively “Gilead” or the “Company”) to recruit and employ the most qualified persons available for positions throughout the Company. All employment actions are administered on a non‑discriminatory basis with regard to protected characteristics. Gilead prohibits discrimination based on any characteristic protected by applicable laws.
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