Senior Clinical Trials Manager - Observational Research
Senior Clinical Trials Manager - Observational Research
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
An exciting position has arisen to join the Clinical Operations team based in our International Headquarters in Stockley Park, Uxbridge, as a Senior Clinical Trial Manager to be responsible for the management of post-authorisation studies and Investigator Sponsored Research across different therapeutic areas.
The role works with Clinical Program Managers to manage the European component of global post-authorisation studies and/or the entire process of an EU post-authorisation study, with the ability to identify issues and adapt to changes.
- Provide support and oversight of Investigator Sponsored Trials including Fair Market Value and feasibility assessment, contract milestone advice, tracking and publication follow-up as required.
- Manages aspects of assigned international post-authorisation studies within designated program budgets and timelines.
- Interacts with cross-functional teams internally and externally to ensure trial progress.
- Will serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems.
- Contributes to development and maintenance of study budgets.
- Contributes to development of RFPs and participate in selection of CROs/vendors.
- Manages CROs/vendors for assigned post-authorisation studies.
- Communicates project status and issues and ensure project team goals are met.
- Contributes to the writing and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans and clinical study reports.
- Maintains study timelines and communicates adjustments where necessary.
- Develops good working relationships with Gilead US late phase operational team and cross-functional staff internationally as required.
- May participate in the preparation of interim/final clinical study reports.
- May contribute to development of abstracts, presentations, and manuscripts.
- Conduct study feasibility in conjunction with internal Medical Affairs and Clinical Operations staff and/or external collaborators or CROs.
- Participate in CRO calls as necessary.
- Contributes to Clinical Operations International 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.
Experience, knowledge and skills:
- Educated to degree level or above in a relevant scientific discipline and relevant clinical experience in the pharmaceutical or health care industry or equivalent.
- Previous experience in the management of Phase IV and Non-Interventional studies essential.
- Experience in the review and oversight of Investigator Sponsored Trials.
- Knowledge of post-marketing requirements and different types of post-authorisation safety and efficacy studies.
- Must be able to generally understand, interpret, and explain protocol requirements to others.
- Good knowledge and understanding of ICH GCP, FDA and EMEA regulations and guidelines applicable to post-authorization studies.
- Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
- 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.
- Occasional International travel may be required.
Gilead Core Value
- Integrity (always doing the right thing),
- Inclusion (encouraging diversity)
- Teamwork (collaborating in good faith),
- Excellence (working at a high level of commitment and capability)
- Accountability (taking personal responsibility).
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation.
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:
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