Clinical Trials Manager
Clinical Trials Manager
United Kingdom - Uxbridge
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and experimental drug candidate, we seek to improve the care of patients suffering from life-threatening diseases around the world. Gilead\'s therapeutic areas of focus include HIV/AIDS, hepatitis, serious respiratory, cardiovascular, and metabolic conditions, cancer and inflammation.
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 Gilead's products.
For the team based in our European Headquarters in Uxbridge, we are looking for a Clinical Trial Manager to work within Virology.
Essential Duties and Job Functions:
- Manages European component of global Phases II-III outsourced studies managed by a Clinical Program Manager.
- 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.
- Ensures effectiveness of site budget/contract process.
- May be asked to train CROs, vendors, investigators, and study coordinators on study requirements.
- Conducts oversight monitoring visits as required.
- Interacts with cross-functional teams internally and externally to ensure trial progress.
Experience, knowledge and skills:
- Educated to degree level or above within a scientific discipline
- Virology experience is highly desired.
- Must have multinational (preferably EU) clinical trials experience including study management/coordination.
- Monitoring experience highly desirable but not essential 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.
- Ability to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
- Must have a general, functional expertise to support SOP development and implementation.
Gilead Core Values
- Integrity (always doing the right thing)
- Teamwork (collaborating in good faith)
- Excellence (working at a high level of commitment and capability)
- Accountability (taking personal responsibility)
- Inclusion (encouraging diversity)
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-Kingdom---Uxbridge/Clinical-Trials-Manager_R0023026-1
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