- 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.
- 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.
- 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
- 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
- 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)
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Senior Clinical Trial Manager Oncology - Uxbridge, United Kingdom - Gilead Sciences Europe Ltd.
Description
Description
Gilead has declared Oncology as one of the key therapeutic areas for future growth. Gilead is growing its pipeline in immune oncology through internal research, partnerships and acquisitions. We are now looking for an experienced Senior Clinical Trial Manager to join the team.
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 commercialisation of Gilead's products.
Essential Duties and Job Functions:
Specific Responsibilities:
Experience, knowledge and skills:
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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