Clinical Trials Manager, Clinical Operations

2 weeks ago

Foster City CA United States Gilead Sciences, Inc. Full time
Clinical Trials Manager, Clinical Operations - Virology

United States – Remote, United States - California - Foster City Clinical Development & Clinical Operations Regular

Job Description

At Gilead, we’re creating a healthier world for all people. 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.

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.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

POSITION OVERVIEW:
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 typically manage Phase I studies or other smaller studies. You will define and incorporate study logistics and study plans to accomplish clinical study objectives. You may also participate in strategic initiatives.

EXAMPLE RESPONSIBILITIES:

  • Manages all components of small clinical studies, including Phase I studies.
  • Manages actively clinical study budgets and exercises proactive financial oversight.
  • Collaborates with other functions on how to best achieve their study goals and objectives and communicates cross-functionally to ensure project team goals are met.
  • With guidance, may lead contract research organization (CRO) and vendor selection and, where applicable, oversees and/or manages interactions and deliverables from relevant CROs, subcontractors, 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 conducting oversight monitoring visits.
  • Defines study logistics and oversees/ develops clinical study plans for assigned clinical studies.
  • Manages study timelines, including documentation and communications.
  • Participates in and manages project meetings and conference calls with CROs, other vendors and cross-functional teams as appropriate.
  • Contributes to SOP development and/or participates in special projects. Develops tools and processes that optimize project efficiencies and effectiveness.
  • Provides input into study protocols, case report forms, and informed consents, oversees/authors study plans, and presentations.
  • Provides oversight of study sites/region and reviews routine regulatory documents to ensure that CROs /vendors are in compliance with protocols, regulatory requirements, SOPs, and monitoring plans.
  • Responsible for Clinical Operations activities conducted by the affiliate that are required by local regulations and/or usual practice to support clinical trials.
  • May be required to present at internal or external meetings (i.e., investigator meetings).
  • Leads or otherwise assists in the preparation of safety, interim and final study reports, including resolving any data discrepancies.
  • Proactively identifies potential operational challenges and collaborates with other Clinical Operations’ colleagues to provide solutions to ensure study execution remains on track to defined protocols, budgets and timelines.
  • Assists in training new or less experienced colleagues.
  • Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

  • MA / MS with 3+ years’ relevant clinical or related experience in life sciences.
  • BA / BS / RN with 5+ years’ 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 managing the work of external vendors.

Knowledge & Other Requirements

  • Demonstrated ability to be a fast learner.
  • Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
  • Ability to manage any component of full cycle study management, from start-up to close-out.
  • Advanced knowledge of study management best practices and tools and has shown ability to apply these to improve study efficiencies and effectiveness.
  • Fully understands protocol requirements and effectively articulates and interprets these.
  • 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.
  • Ability to communicate in a clear and concise manner.
  • Ability to support a team-oriented, highly-matrixed environment.
  • Ability to execute multiple tasks as assigned.
  • When needed, ability to travel.
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