Clinical Trials Management Associate- LVD For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. Job Description Specific Responsibilities and Skills for Position: - Must meet all requirements for Clinical Project Assistant position and have demonstrated proficiency in all relevant areas -Under supervision serves as the key operational contact with external investigators and internal stakeholders, for successful implementation of Gilead (GS), Collaborative (CO), Investigator Sponsored Research (ISR) Studies, expanded access programs, and compassionate use programs

• Under supervision may serve as the key operational contact for Gilead (GS) studies, providing assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs -May take part in fair market evaluations ISRs in collaboration with Clinical Pricing department -May participate in coordination and input to periodic safety update reports and development safety update reports when requested -Communicates and collaborates with Medical Affairs, Clinical Research, Regulatory Affairs, CCF, Clinical Supply Management, and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities -Proactively identifies potential operational challenges and in collaboration with senior team members provides solutions to ensure study execution remains on track -Supports study drug planning and shipping activities -Ensures all protocol, budget, contract are appropriately approved, executed, and documented. -Forecasts, tracks and reports CO and ISR milestones and ensures invoice payment. -Provides monthly study updates to the appropriate internal stakeholders. -Maintains internal Clinical Operations databases and document repositories - Must be familiar with routine medical/scientific terminology - Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision - Assists in preparation of safety, interim and final study reports, including resolving data discrepancies - Under supervision may assist in review of protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports - May contribute to SOP development - For GS studies, may monitor or co-monitor 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 - May resolve routine monitoring issues - Travel may be required - Responsible for the oversight and management of investigator-sponsored and collaborative studies Knowledge: - Excellent verbal, written, interpersonal and presentation skills are required - Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies - Working knowledge and experience with Word, PowerPoint and Excel Experience and Skills: - At least 1+ year of relevant experience and a BS or BA in a relevant scientific discipline or - At least 1+ year of experience and an RN (2 or 3 year certificate)

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