Senior Clinical Trials Management Associate

Kite Pharma•Foster City, CA

1d•$126,820 - $164,120

About The Position

Kite Pharma is a biopharmaceutical company focused on developing innovative cancer immunotherapies. The company is dedicated to creating personalized CAR T-cell therapies to combat cancer. This role is part of the Clinical Operations team, which is responsible for the global execution of clinical trials across all therapeutic areas. The team ensures trials are conducted according to SOPs, company policies, and regulatory guidelines to provide high-quality data for product registration and commercialization. The Senior Clinical Trials Management Associate will support the Clinical Operations team in various stages of clinical studies, potentially managing specific study components, acting as a study team member, leading studies at certain sites, managing vendors, and overseeing investigator-sponsored research. The role may also involve reviewing study protocols and documents, contributing to SOP development, and participating in special projects.

Requirements

Associate's degree and 5 years' experience
Bachelor's Degree and 4 years' experience
Master's Degree and 2 years' experience
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.

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.
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.