Senior Clinical Trials Management Associate

Kite Pharma • Parsippany, NJ

2d • Onsite

About The Position

Kite is dedicated to curing cancer through the development of treatments, including pioneering personalized CAR T-cell therapies. The company aims to make significant advances in cancer therapies and shape the future of medical science. Gilead, the parent company, strives for a healthier world by developing treatments for hepatitis C, HIV, viral and inflammatory diseases, and certain cancers, confronting major public health challenges. The Clinical Operations department is responsible for the global execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. This department ensures that all clinical trials adhere to applicable SOPs, company policies, and regulatory guidelines to provide timely, high-quality clinical data supporting global registration and commercialization of Gilead’s products. In this role, you will support other Clinical Operations team members throughout the start-up, maintenance, and close-out phases of clinical studies. You may manage specific components of clinical studies, serve as a study team member, lead clinical studies at various sites, manage vendors, and/or oversee investigator-sponsored research. Additionally, you may contribute to the review of clinical study protocols and other study documents, participate in SOP development, and engage in special projects.

Requirements

• Associates Degree and 5 years experience OR Bachelor's Degree and 4 years experience OR Master's Degree and 2 years experience

Nice To Haves

• 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.
• Knowledge of full cycle clinical study management, from start-up to close-out, and has shown ability to effectively apply this knowledge to achieve targeted study outcomes.
• Significant industry knowledge.
• Complete knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools.
• 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.

Responsibilities

• May lead or manage components of Phase I, II, III or IV studies or manage investigator-sponsored research.
• Maintains internal Clinical Operations databases and document repositories.
• Assists in contract research organization (CRO) and vendor selection and, where applicable, coordinates all interactions and deliverables from CROs and vendors.
• Typically serves as the key operational contact for Gilead studies; provide oversight for the conducts site evaluation, initiation, and close-out visits in addition to routine monitoring visits, either directly or through CROs.
• Manages study timelines, including documentation and communications.
• Participates in and manages project meetings and conference calls with CROs, other vendors and cross-functional teams.
• Provides input into study protocols and case report forms, authors informed consents, study plans, and presentations.
• Contributes to SOP development and/or participates in special projects.
• Develops tools and processes that optimize project efficiencies and effectiveness.
• Provides oversight of study sites and reviews routine regulatory documents to ensure that CROs are in compliance with protocols, regulatory requirements, SOPs, and monitoring plans.
• 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.

Benefits

• discretionary annual bonus
• discretionary stock-based long-term incentives (eligibility may vary based on role)
• paid time off
• company-sponsored medical, dental, vision, and life insurance plans

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree
• Number of Employees: 501-1,000 employees