Senior Clinical Trial Management Associate - Virology
Senior Clinical Trial Management Associate - 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 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.
The Senior CTMA role will involve assisting global trial managers on Phase Ib-III clinical studies, with a strong emphasis on the EMEA region. The successful candidate will be a member of the Global Study team overseen by a Clinical Program Manager. 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.
Essential Duties and Job Functions:
- Provides administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
- Assist global trial managers with set-up of central labs and study vendors as required, including liaising with study management CRO to ensure site training and timely initiation.
- Performs accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs to ensure correct study procedures according to Gilead SOPs and protocol procedures, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
- Under supervision may assist in review of protocols, informed consents, and case report forms, monitoring plans, study plans, abstracts, presentations, manuscripts and clinical study reports. May assist in compilation of investigator brochures under close supervision.
- Review of trip reports generated by CRO CRAs
- Communicates and collaborates with other functional groups including but not limited to Clinical Research, Regulatory Affairs, Development Business Operations (DBO), Clinical Supply Management (CSM) and Pharmacovigilance (PVE) to ensure efficient management of study activities.
- Assists with the preparation and organization of international investigator meetings
- Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
- Performs administrative duties in a timely manner as assigned.
- Travel is required up to 20%.
Experience, knowledge and skills:
- Educated to degree level or equivalent within a relevant scientific discipline
- Relevant clinical trial experience in the pharmaceutical or health care industry or equivalent.
- CRA experience preferred.
- Excellent verbal, written, interpersonal and presentation skills are required.
- Must be familiar with routine medical/scientific terminology.
- Must be familiar with Word, PowerPoint, and Excel.
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
- Organised with systematic approach to prioritisation.
- Must be able to participate in departmental or interdepartmental strategic initiative under general supervision.
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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