Clinical Trials Manager, Clinical Operations - Virology

Arbeitsbeschreibung

Clinical Trials Manager, Clinical Operations - Virology

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.