Senior Clinical Trials Manager
Senior 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
At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day - discoveries that include our own capabilities and our individual potential.
An exciting and challenging opportunity has arisen to join the European Headquarters based in Stockley Park, Uxbridge as a Senior Clinical Trials Manager.
Essential Duties and Job Functions:
- Manages component of global 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.
- 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.
- Assists in determining the activities to support a project's priorities within functional area.
- Partners with Clinical Program Managers and Managers in other functions, providing input where key decisions impacting business operations will be made.
- Works with Clinical Program Managers to manage processes of clinical trial and with latitude for independent judgment and decision-making within defined guidelines.
- Demonstrated success in managing members of the team and supporting their professional development.
- Excels in project management and demonstrates ability to take on more studies and/or studies of greater complexity by managing through others or delegation.
- Understands how the design and operations of clinical trials impact the goals of various functions.
- In partnership with CPMs, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines.
- Contributes to development of abstracts, presentations and manuscripts.
Experience, knowledge and skills:
- Educated to degree level or above within a scientific discipline
- Oncology experience is essential
- Must have previous study management experience at trial management level
- Previous monitoring experience is desired but not essential for the role
- Line management is desired but not essential
- 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 have a general, functional expertise to support SOP development and implementation
- Excellent teamwork, decision-making, communication and organisational skills
Gilead & Kite 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)
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system\'s ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
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 Kite Pharma Employees and Contractors:
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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-Kingdom---Uxbridge/Senior-Clinical-Trials-Manager_R0022919-1
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