Clinical Trial Management Associate - Inflammation

Clinical Trial Management Associate - Inflammation
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 Phase 1-3 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 commercialization of Gilead's products.

For the team based in our International Headquarters in Uxbridge, we have an exciting opportunity for a Clinical Trial Manager Associate to work within the Inflammation therapy area.

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, IMVs) 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, 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, CCF, Materials and Logistics (M&L), and Pharmacovigilance & Epidemiology (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 could be required up to 20-30% if no travel restrictions are in place.

Experience, knowledge and skills:

• Educated to degree level or above within a relevant scientific discipline
• Relevant clinical trial experience in the pharmaceutical or health care industry or equivalent.
• CRA experience preferred.
• Inflammation experience preferred but not essential.
• 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 EMEA Regulations, ICH Guidelines, and GCP governing the conduct of clinical trials.
• Must be able to participate in departmental or interdepartmental strategic initiative under general supervision.

Gilead Core Values

• Integrity (Doing What's Right)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• 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:
Please log onto your Internal Career Site to apply for this job.


To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-Kingdom---Uxbridge/Clinical-Trial-Management-Associate---Inflammation_R0016910-1





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