Clinical Trial Manager

2 weeks ago

Uxbridge Greater London, United Kingdom Gilead Sciences, Inc. Full time

Clinical Trial Manager
United Kingdom - Uxbridge Clinical Development & Clinical Operations Regular Job Description
For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together. Clinical Trial Manager (CTM)
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987, that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.
Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development.
Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead’s products.
You will manage a geographical region(s) of assigned clinical studies or multiple components of larger studies. You will define and incorporate study logistics and study plans to accomplish clinical study objectives. Manages all components of small clinical studies, including Phase I studies.
With guidance, may lead contract research organization (CRO) and vendor selection and, where applicable, manages all interactions and deliverables from relevant CROs and vendors.
Typically serves as the key operational contact for Gilead studies, providing oversight for the site evaluation, initiation, and close-out visits in addition to routine monitoring visits, either directly or through CROs.
Defines and develops the study logistics and clinical study plan for assigned clinical studies.
Participates in and manages project meetings and conference calls with CROs, other vendors and cross-functional teams.
Contributes to SOP development and/or participates in special projects. Develops tools and processes that optimize project efficiencies and effectiveness.
Provides oversight of study sites/region and reviews routine regulatory documents to ensure that CROs are in compliance with protocols, regulatory requirements, SOPs, and monitoring plans.
Leads or otherwise assists in the preparation of safety, interim and final study reports, including resolving any data discrepancies.
Assists in training new or less experienced colleagues.
Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
BA / BS / MA / MS / PharmD / PhD or equivalent with significant relevant clinical or related experience in life sciences.
Multiple years’ clinical or related experience in life sciences, including experience leading or managing less complex studies and project teams.
Experience specific to the running of a FIH (First In Human) studies within the EMEA.
Experience of the regulatory and site start up requirements for clinical sites with preferably hands-on experience with filing a clinical trial application in key EMEA countries like UK, EU big 5 and Israel
Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
Knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies.
Familiar with standard medical / scientific terminology.
When needed, ability to travel
Everyone at Gilead is motivated by our overarching mission to discover and deliver innovative therapies that improve patient care in areas of unmet medical needs. Inclusion (encouraging diversity)

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
We promote and support individual differences and diversity of thoughts and opinion.
Full Time/Part Time Full-Time

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