Clinical Trial Manager

Job title:

Medical Trial Supervisor

Firm

Gilead

Job description

For Present Gilead Workers and Contractors:Please log onto your to use for this job.At Gilead, we’re making a more healthy world for all folks. For greater than 35 years, we’ve tackled illnesses comparable to HIV, viral hepatitis, COVID-19 and most cancers – working relentlessly to develop therapies that assist enhance lives and to make sure entry to those therapies throughout the globe. We proceed to struggle towards the world’s greatest well being challenges, and our mission requires collaboration, willpower and a relentless drive to make a distinction.We empower our leaders to step up, share concepts, pay attention, be taught, and lead. We’re welcoming vivid, numerous, and imaginative minds; we’re nurturing them to foster an atmosphere of inclusion and development the place innovation is inspired. We count on our folks leaders to mannequin that atmosphere, and to give attention to creating inclusion, creating expertise, and enabling groups.Each member of Gilead’s crew performs a vital position within the discovery and growth of life-changing scientific improvements. Our workers are our best asset as we work to attain our daring ambitions, and we’re on the lookout for the following wave of passionate and bold folks able to make a direct affect. Be part of Gilead and assist create attainable, collectively.Job DescriptionMedical Trial Supervisor (CTM)Gilead Sciences, Inc. is a research-based biopharmaceutical firm based in 1987, that has pursued and achieved breakthroughs in medication for greater than three a long time, with the purpose of making a more healthy world for all folks.Collectively we ship life-saving therapies to sufferers in want. With the dedication and drive you carry to the office day-after-day, you may be a part of a crew that’s altering the world and serving to tens of millions of individuals reside more healthy, extra fulfilling lives. Our worldwide workers is a detailed neighborhood the place you’ll be able to see the tangible outcomes of your contributions, the place each particular person issues, and everybody has an opportunity to boost their expertise by means of ongoing growth.This place is predicated in our workplaces in Stockley Park, UK.POSITION OVERVIEW:Medical Operations is accountable for the worldwide execution of all Section I – IV medical trials throughout all Gilead therapeutic areas. Medical Operations performs a key position in guaranteeing all Gilead medical trials are carried out in accordance with relevant SOPs, firm insurance policies and regulatory tips to offer well timed and high-quality medical information that helps international registration and commercialization of Gilead’s merchandise.You’ll handle a geographical area(s) of assigned medical research or a number of parts of bigger research. You’ll usually handle Section I research or different smaller research. You’ll outline and incorporate research logistics and research plans to perform medical research goals. You may additionally take part in strategic initiatives.EXAMPLE RESPONSIBILITIES:Manages all parts of small medical research, together with Section I research.With steerage, might lead contract analysis group (CRO) and vendor choice and, the place relevant, manages all interactions and deliverables from related CROs and distributors.Sometimes serves as the important thing operational contact for Gilead research, offering oversight for the positioning analysis, initiation, and close-out visits along with routine monitoring visits, both straight or by means of CROs.Defines and develops the research logistics and medical research plan for assigned medical research.Manages research timelines, together with documentation and communications.Participates in and manages mission conferences and convention calls with CROs, different distributors and cross-functional groups.Contributes to SOP growth and/or participates in particular tasks. Develops instruments and processes that optimize mission efficiencies and effectiveness.Supplies enter into research protocols and case report kinds, authors knowledgeable consents, research plans, and displays.Supplies oversight of research websites/area and critiques routine regulatory paperwork to make sure that CROs are in compliance with protocols, regulatory necessities, SOPs, and monitoring plans.Could also be required to current at inner or exterior conferences (i.e., investigator conferences).Leads or in any other case assists within the preparation of security, interim and last research studies, together with resolving any information discrepancies.Proactively identifies potential operational challenges and collaborates with different Medical Operations’ colleagues to offer options to make sure research execution stays on observe to outlined protocols, budgets, and timelines.Assists in coaching new or much less skilled colleagues.Ensures personal work complies with established practices, insurance policies and processes, and any regulatory or different necessities.REQUIREMENTS:We’re all completely different, but all of us use our distinctive contributions to serve sufferers. Please see the next for the {qualifications} and expertise we look for this position.Minimal Schooling & ExpertiseBA / BS / MA / MS / PharmD / PhD or equal with vital related medical or associated expertise in life sciences.A number of years’ medical or associated expertise in life sciences, together with expertise main or managing much less advanced research and mission groups.Expertise managing the work of exterior distributors.Information & Different NecessitiesExpertise particular to the working of a FIH (First In Human) research throughout the EMEA.Expertise of the regulatory and web site begin up necessities for medical websites with ideally hands-on expertise with submitting a medical trial software in key EMEA international locations like UK, EU large 5 and IsraelDemonstrated capacity to be a quick learner.Demonstrated capacity to be versatile and adaptable to vary, to maneuver between tasks simply and supply help/experience the place wanted.Capability to handle any part of full cycle research administration, from start-up to close-out.Superior data of research administration greatest practices and instruments and has proven capacity to use these to enhance research efficiencies and effectiveness.Totally understands protocol necessities and successfully articulates and interprets these.Information of Meals & Drug Administration (FDA), European Medicines Company (EMA), and different relevant nationwide rules, Worldwide Council for Harmonisation of Technical Necessities for Prescription drugs for Human Use (ICH) tips and Good Medical Apply (GCP) governing the conduct of medical research.Conversant in customary medical / scientific terminology.Capability to speak in a transparent and concise method.Capability to help a team-oriented, highly-matrixed atmosphere.Capability to execute a number of duties as assigned.When wanted, capacity to journeyThe Gilead DistinctionEverybody at Gilead is motivated by our overarching mission to find and ship modern therapies that enhance affected person care in areas of unmet medical wants. However it’s simply what we do that offers us an edge, it’s how we do it. We count on everybody at Gilead to steer by instance, guided by our core values:Integrity (at all times doing the precise factor)Teamwork (collaborating in good religion)Excellence (working at a excessive degree of dedication and functionality)Accountability (taking private accountability)Inclusion (encouraging variety)Equal Employment Alternative (EEO)It’s the coverage of Gilead Sciences, Inc. and its subsidiaries and associates (collectively “Gilead” or the “Firm”) to recruit choose and make use of essentially the most certified individuals accessible for positions all through the Firm. Besides if in any other case offered by relevant regulation, all employment actions referring to points comparable to compensation, advantages, transfers, layoffs, returns from layoffs, company-sponsored coaching, schooling help, social and leisure applications are administered on a non-discriminatory foundation (i.e. with out regard to protected traits or prohibited grounds, which can embrace a person’s gender, race, coloration, nationwide origin, ancestry, faith, creed, bodily or psychological incapacity, marital standing, sexual orientation, medical situation, veteran standing, and age, until such safety is prohibited by federal, state, municipal, provincial, native or different relevant legal guidelines). Gilead additionally prohibits discrimination primarily based on another traits protected by relevant legal guidelines.For Present Gilead Workers and Contractors:Please log onto your to use for this job.

Anticipated wage

Location

Uxbridge, Better London

Job date

Thu, 04 Apr 2024 22:22:49 GMT

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