Senior Clinical Trials Management Associate

Kite Pharma•Santa Monica, CA

22h

About The Position

At Gilead, our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention, as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. 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 support other Clinical Operations team members in the start-up, maintenance and close-out of clinical studies. You may manage certain components of clinical studies and act as a member of the study team. You may also lead clinical studies at certain sites, manage vendors and/or manage investigator-sponsored research. You may assist in the review of clinical study protocols and other study documents, contribute to SOP development and/or participate 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
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.