Clinical Trial Manager, Clinical Operations- Virology

$143,225 - $185,350/Yr

Gilead Sciences - Parsippany-Troy Hills, NJ

Full-time - Mid Level

Parsippany-Troy Hills, NJ

Chemical Manufacturing

About the position

The Clinical Trial Manager in Clinical Operations at Gilead Sciences is responsible for managing clinical studies, particularly Phase I studies, ensuring they are executed in compliance with regulatory guidelines and company policies. This role involves overseeing study logistics, budgets, and timelines, collaborating with cross-functional teams, and providing operational oversight for clinical trials to support the development of life-changing therapies.

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.
• Leads contract research organization (CRO) and vendor selection and oversees interactions and deliverables from relevant CROs, subcontractors, and vendors.
• Serves as the key operational contact for Gilead studies, providing oversight for site evaluation, initiation, and close-out 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 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 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

• MA / MS / PharmD / PhD 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.
• 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 FDA, EMA, and other applicable national regulations, ICH guidelines and 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.

Nice-to-haves

• Ability to travel when needed.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.
• Discretionary annual bonus.
• Discretionary stock-based long-term incentives.
• Paid time off.