Clinical Trials Manager
6 months ago
For Current Gilead Employees and Contractors:
At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
**Job Description**:
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.- 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.- Manages study timelines, including documentation and communications.- 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 input into study protocols and case report forms, authors informed consents, study plans, and presentations.- 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.- 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- PharmD / PhD with 2+ years’ relevant clinical or related experience in life sciences.- 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.- Meets all requirements for Senior Clinical Trial Management Associate (Senior CTMA) grade 26 position with demonstrable proficiency.
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.-
- Fully understands protocol requirements and effectively articulates and interprets these.- Thorough 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.
For Current Gilead Employees and Contractors:
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