Senior Clinical Trial Management Associate Late Phaseスペイン - マドリード臨床開発・クリニカルオペレーション正社員
Senior Clinical Trial Management Associate Late Phase
An exciting opportunity has arisen to join the expanding European Clinical Operations team as a Senior Clinical Trial Management Associate (SCTMA) working on post-authorisation studies and Investigator Sponsored Research across different therapeutic areas.
This position is based in our Gilead office in Madrid, Spain.
Essential Duties and Job Functions
Senior CTMA-Late Phase plays a vital role in successful implementation and support of important Gilead Sponsored, Collaborative (CO) and Investigator-Sponsored Research (ISR) projects.
For CO and ISR with supervision:
- Serves as the key operational contact with external investigators and internal stakeholders.
- Evaluates scientific proposals or protocols to identify logistical, 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 company’s Development Business Operations (DevBusOps) team and external investigator/study representative to ensure contracts are executed in a timely manner.
- Supports study drug planning and shipping activities with Clinical Supply Management.
- Communicates and collaborates with other functional groups including but not limited to Medical Affairs, Regulatory Affairs, DevBusOps, Clinical Supply Management (CSM), and Global Patient Safety (GLPS) to ensure efficient management of study activities.
- Forecasts, tracks and reports CO and ISR milestones, 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.
- Maintains internal Clinical Operations and Medical Affairs databases and clinical study data and document repositories.
For Gilead Sponsored non-interventional trials:
- Provides administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
- May monitors fairly routine study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
- Under supervision may assist in development and review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports.
- Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
- Travel might be required.
Knowledge, Skills and Experience
- Educated to degree level or above within a scientific discipline and relevant clinical experience in the pharmaceutical or health care industry or equivalent.
- Previous experience of working on Investigator Sponsored Research (ISR) and Non-Interventional studies is highly desired
- Excellent planning, time management, organisational, and administrative skills.
- Able to maintain internal/external networking and cross-functional collaboration.
- 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 and guidelines applicable to post-authorization studies.
- Must be proficient with MS Word, PowerPoint, Outlook, and Excel.
- Must be able to contribute to SOP development.
- Check on country specification/regulation re posting required years of experience and/or adjust wording accordingly.
- SCTMA: at least 3+ year of experience and a BS/BA in a relevant scientific discipline [or 2 or 3 year certificate as Research Nurse (UK specific-please adjust to local wording as possible)]
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)
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation.