Clinical Trials Management Associate - II
CTMA -Late Phase plays vital role in successful implementation and support of important Collaborative (CO) and Investigator-Sponsored Research (ISR) projects. With supervision:
• Serves as the key operational contact with external investigators and internal stakeholders.
• Able to evaluate a scientific proposal or protocol 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 and financial or Gilead product support are processed in a timely manner and to high quality.
• Proactively identifies operational challenges and in collaboration with senior team members provides and implements solutions to ensure study remains on track.
• Maintains efficient collaboration with companys Clinical Contracts and Finance (CCF) team and external investigator/study representative to ensure contracts are executed in 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.
• Performs administrative duties in a timely manner as assigned.
May contribute to Gilead sponsored studies:
• 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.
• May assist in compilation of investigator brochures under close supervision. Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
• Travel might be required.
Skills required demonstrating key Gilead core values of Integrity, Teamwork, Excellence, and Accountability
• Excellent planning, time management, organizational, and administrative skills.
• Demonstrates core values of strong team work and accountability with ability to prioritize competing timelines and deliver excellent results
• Learning ability with demonstrated flexibility required to maintain a fast pace
• Effective communication skills, both oral and written and interpersonal and presentation skills.
• Tenacity and perseverance to ensure high level customer service.
• Teamwork is a mandatory requirement as it involves building and maintaining internal/external networking and cross-functional collaboration.
• 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.
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials, and ability to understand clinical study protocols a plus
• 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.
• Typically requires a BS or BA in a relevant scientific discipline and minimum 2 years relevant clinical experience in the pharmaceutical or health care industry or equivalent.