Senior Clinical Trials Manager - Virology
Senior Clinical Trials Manager - Virology
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
The Senior Clinical Trial Manager role will involve global management of Phase Ib-III clinical studies with an emphasis on the EMEA region and/or regional management of highly demanding and complex Phase Ib-III studies. The role will also entail line management responsibilities for personnel within the International Head Office Clinical Operations group.
The successful candidate will be a member of the Global Study Management team overseen by a Clinical Program Manager, and will manage other clinical operations team members to perform regional or vendor lead roles. The candidate will likely work across several studies, including involvement from study start-up through study close-out activities, and will work with the CRO to execute the study to agreed timelines and budget. The successful candidate will have the ability to work successfully with cross-functional team members globally and to manage stakeholders accordingly.
Essential Duties and Job Functions
- Leads global PIb-III studies managed by 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 participates in selection of CROs/vendors.
- Manages CROs/vendors
- Coordinates review of data listings and preparation of interim/final clinical study reports
- May contribute to development of abstracts, presentations, and manuscripts
- Ensures effectiveness of site budget/contract process
- Train CROs/vendors/investigators/study coordinators on study requirements.
- Conducts Monitoring/co-monitoring as required
- Assists in determining the activities to support a project's priorities within functional area
- Coordinates and supervises all aspects of a clinical study
- Assists Clinical Operations International Therapeutic Area Leads in their duties
- Contributes to Clinical Operations International team activities & initiatives
- Collaborates with local medical affairs colleagues on country specific studies and initiatives
- Provides knowledge and expertise on country specific regulations and site experience and suitability for development studies
- 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
- Delegate tasks to direct reports, with the ability to coordinate and allocate responsibilities based on complexity of work and skill set of CTMs, CTMAs and CPAs
- Some International travel is required.
- Works with Clinical Program Managers to manage Virology clinical trials and/or the entire process of a local clinical trial, with the ability to identify issues and adapt to changes
- Interacts with cross-functional teams internally and externally to ensure trial progress
- Will incorporate study logistics and planning to accomplish study objectives
- Will serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems
Knowledge, Experience and Skills
- Significant relevant experience and a BSc or nursing qualification in a relevant scientific discipline
- Previous experience in Virology areas would be advantageous but not essential
- Must have previous study management/coordination experience at CTM level
- Must have monitoring experience as co-monitoring 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
- Must be able to prioritize multiple tasks
- Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
- Must have a general, functional expertise to support SOP development and implementation
- Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction
- Excellent teamwork, decision-making and organizational skills are key to success
- Strong communication skills
- Line Management or mentoring experience would be advantageous but is not essential.
- Curious with a strong learning agility (the ability to rapidly study, analyse and understand new situations and problems)
- Operationally excellent and resilient in the context of a rapidly changing environment
- Organised with systematic approach to prioritization
- Exhibit Gilead's Core Values.
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)
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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