Senior CTM Associate
Senior CTM Associate
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1 Vacancy
Job Description
At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads 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 were 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 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/Gileads 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 a hybrid working structure of 3 days per week in the office.
Essential Duties and Job Functions:
- Assist global 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 CROs and vendors 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 is required 1 or 2 times per year
- 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 presentation skills are required.
- Must be familiar with routine medical/scientific terminology.
- Must be proficient with Word PowerPoint and Excel.
- Knowledge of FDA and/or EMEA Regulations ICH Guidelines and GCPs governing the conduct of clinical trials is desirable. -
- The candidate should be skilled in communication time management organization and prioritization. - Previous experience in clinical research sites/hospitals CROs or pharmaceutical companies is desirable. - Knowledge of European regulations for clinical trials is desirable. Gilead Core Values Integrity (always doing the right thing) Teamwork (collaborating in good faith) Excellence (working at a high level of commitment and capability) Accountability (taking personal responsibility) Inclusion (encouraging diversity
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs company-sponsored training education assistance social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Senior IC
Employment Type
Full-Time
