Clinical Trials Management Associate

3 weeks ago

Uxbridge, United Kingdom Gilead Sciences Full time

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

**For Current Gilead Employees and Contractors:
**Job Description**:**Gilead has declared Oncology as one of the key therapeutic areas for future growth. Gilead is growing its pipeline in immune oncology through internal research, partnerships and acquisitions.**
**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 /Gilead’s products.**

**We are now looking for an experienced Clinical Trials Management Associate (CTMA) to join the team.**
**Essential Duties And Job Functions**:

- **Provide assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.**:

- **Assist global/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 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 up to 20%.**
**Experience, Knowledge & 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 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.**:

- **Must be able to participate in departmental or interdepartmental strategic initiative under general supervision
**_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 individual’s 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:

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