Sr. CTM Associate

Sr. CTM Associate page is loaded## Sr. CTM Associate remote type:
Onsite Required locations:
United Kingdom - Uxbridgetime type:
Full time posted on:
Posted Todayjob requisition :
R0049924

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

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 Gilead and help create possible, together.

** Job Description
** Kite, a Gilead Company, is a biopharmaceutical company that is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies.
The Clinical Operations team is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Kite/Gilead’s products.

For the team based in our European Headquarters in Uxbridge, we are looking for a Senior Clinical Trials Management Associate to work within the Oncology Disease/Cell Therapy therapeutic area. This is an onsite working structure with a minimum of 3 days per week in the office.

Essential Duties and

Job Functions:

Assist global and regional trial managers with set-up of central labs and study vendors as required, including liaising with study management CRO to ensure site training and timely initiation.  Performs accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs to ensure correct study procedures according to Gilead SOPs and protocol procedures, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.  

Under supervision may assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports. May assist in compilation of investigator brochures under close supervision Review of trip reports generated by CRO CRAs.  Communicates and collaborates with other functional groups including but not limited to Clinical Research, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities.  

Assists in the Management of the CRO’s and vendor’s as required.  Assists with the preparation and organization of international investigator meetings  Assists in preparation of safety, interim and final study reports, including resolving data discrepancies. Performs administrative duties in a timely manner as assigned.  Travel may be required 1 or 2 times per year (a few days)
Experience, knowledge and skills:  Educated to degree level or equivalent in a scientific discipline  Previous experience of pharmaceutical clinical trial experience  CRA experience is highly desired  Oncology experience is required / CAR-T Cell Therapy would be desirable

Excellent verbal, written, interpersonal and…