Senior Ctma Late Phase
2 weeks ago
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**Job Description**:
An exciting opportunity has arisen to join the expanding Late Phase Clinical Operations team based in our International Headquarters in Stockley Park, Uxbridge, as a Senior Clinical Trial Manager Associate within the Non-Gilead Sponsored (Non-GS) Research Group.
Essential Duties and Job Functions
A SCTMA - Late Phase plays a vital role in successful implementation and support of important Collaborative (CO) and Investigator-Sponsored Research (ISR) projects:
- Serves as the key operational contact with external investigators and internal stakeholders.
- Evaluates scientific proposals or protocols to identify logístical, regulatory and safety elements and implications.
- Manages assigned studies by establishing strong partnerships with external investigators and collaborators to ensure CO and ISR Agreements for financial or Gilead product support are processed in a timely manner and to a high quality.
- Proactively identifies operational challenges and in collaboration with senior team members provides and implements solutions to ensure studies remain on track.
- Maintains efficient collaboration with Gilead Clinical Pricing and Finance teams and external investigator/study representative to ensure contracts are executed in a timely manner.
- Supports study drug planning and shipping activities with Gilead Clinical Supply Chain Management (CSCM) teams.
- Communicates and collaborates with other Gilead functional groups, including but not limited to; Medical Affairs, Regulatory Affairs, Clinical Pricing, Clinical Supply Chain Management (CSCM), and Patient Safety to ensure efficient management of study activities.
- Forecasts, tracks and reports CO and ISR milestones within Gilead Clinical Trial Management Systems (CTMS), as well as verifies completeness of the study milestones prior to invoice payment.
- Provides monthly study updates to the appropriate internal stakeholders.
- Ensures all budget or drug supply modifications are appropriately approved, documented and tracked.
- Implements working processes to promote high quality, efficient, and compliant systems for Late Phase research management.
- Supports and implements Clinical Operations Quality Initiatives.
- Maintains internal Clinical Operations and Medical Affairs databases, tracking systems and clinical study data and document repositories.
- Performs administrative duties in a timely manner as assigned.
Knowledge, Skills and Experience
- Typically requires a BSc in a relevant scientific discipline and relevant clinical experience in the pharmaceutical or health care industry or equivalent.
- Excellent planning, time management, organizational, and administrative skills.
- Demonstrates core values of strong teamwork and accountability with ability to prioritize competing timelines and deliver excellent results.
- Learning ability with demonstrated flexibility required to maintain a fast pace.
- Excellent verbal, written, interpersonal and presentation skills are required.
- Tenacity and perseverance to ensure a high level of customer service.
- Able to maintain internal/external networking and cross-functional collaboration.
- Demonstrates a high sense of urgency and commitment to excellence in the successful execution of deliverables.
- Must be able to prioritize multiple tasks and accomplish goals using well-defined instructions and procedures.
- Good knowledge and understanding of ICH GCP, FDA and EMEA regulations
- Must be proficient with MS Word, PowerPoint, Outlook, and Excel.
- Must be familiar with routine medical/scientific terminology.
- Must be able to participate in departmental or interdepartmental strategic initiative under general supervision.
- Must be able to contribute to SOP development as required.
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
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