Clinical Trial Manager AssociateUnited States - California - Foster CityClinical Development & Clinical OperationsRegular
CLINICAL OPERATIONS: Clinical Operations 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 Development Operations functions, ensures that all clinical trial activities are performed in accordance with all 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.
Clinical Trials Management Associate (CTMA)
Specific Responsibilities and Skills for Position:
CTMA-Late Phase plays a vital role in successful implementation and support of important Gilead Sponsored non-interventional, Collaborative (CO) and Investigator-Sponsored Research (ISR) projects.
For Gilead Sponsored non-interventional trials:
- Must be familiar with routine medical/scientific terminology
- Maintains internal Clinical Operations databases and document repositories
- 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 assist to set up, organize and maintain clinical study documentation (e.g. Trial Master Files) including preparation for internal/external audits, final reconciliation and archival
- Under supervision may assist in preparation and development of protocols, informed consents, monitoring plans and other study related plans.
- Under supervision may assist in review of case report forms, abstracts, presentations, manuscripts and clinical study reports.
- 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
- Proactively identifies potential operational challenges and in collaboration with senior team members provides solutions to ensure study execution remains on track
- Assists in preparation of safety, interim and final study reports, including resolving data discrepancies
- Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision
- May contribute to SOP development
- Travel may be required
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 Clinical Contracts and Finance (CCF) team and external investigator/study representative to ensure contracts are executed in a timely manner.
- Supports study drug planning and shipping activities with Materials & Logistics.
- Communicates and collaborates with other functional groups including but not limited to Medical Affairs, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) 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.
- Supports and implements Clinical Operations Quality Initiatives.
- Maintains internal Clinical Operations and Medical Affairs databases and clinical study data and document repositories.
- 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 2+ year of relevant experience and a BS or BA in a relevant scientific discipline or
- At least 2+ year of experience and an RN (2 or 3 year certificate)
- Prior oncology clinical trials experience is preferred