Senior Clinical Trials Management Associate

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Job Description

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.

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 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.

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.

Basic  Qualifications:

• Associates Degree and 5 years experience

OR

• Bachelor's Degree and 4  years experience

OR

• Master's Degree and 2  years experience

Preferred Qualifications:

• Experience managing the work of external vendors

• Demonstrated ability to be a fast learner.

• Demonstrated