Description
EXAMPLE RESPONSIBILITIES:
· Manages a geographical (region)s of assigned clinical studies or multiple components of larger studies .
· Collaborates with other functions on how to best achieve study goals and objectives and communicates cross-functionally to ensure project team goals are met.
· With guidance, may 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 oversight CRO conducted monitoring visits.
· Defines study logistics and oversees/ develops clinical study plans for assigned clinical studies.
· Manages study timelines, including documentation and communications.
· Participates and/or acts as a Business Lead in initiatives / projects 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.
· May be required to present at internal.
· 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 / PharmD / PhD with 3+ years’ relevant clinical experience in life sciences, or BA / BS / RN with 5+ years’ relevant clinical experience in life sciences.
· Minimum of 2 years of Post-Authorization Non-Interventionalstudy management experience at international level.
· Experience in managing sites activities as study coordinator, or in oversight site activities as Clinical Research Associate (CRA).
· Experience in working with cross-functional stakeholders as Medical Affairs and Real Word Evidence/Epidemiologist teams.
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.
· In deep knowledge of Good Pharmacovigilance Practice (GVP) and related key modules, as well as FDA RWE guidances.
· 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.
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 apply via the Internal Career Opportunities portal in Workday.