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Sr. CTMA - Late Phase Clinical Operations
Non-Client sponsored studies:
Sr. CTMA -Late Phase plays 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.
• Has ability to evaluate a scientific proposal or protocol to identify logistical, regulatory and safety 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 potential operational challenges and in collaboration with senior team members provides solutions to ensure study remains 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 timely manner.
• Acts as primary contact for study drug planning and shipping 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.
• Contributes to implementation and maintenance of the working processes to promote high quality, efficient, and compliant systems for Late Phase research management.
• In collaboration with the Clinical Program Manager (CPM), provides training for new hires, as applicable.
• Provide support and guidance, as required, to Affiliate Clin Ops & Medical Affairs personnel responsible for managing CO and ISR studies.
• Maintains a good understanding of industry standards for CO and ISR studies and keeps abreast of any new changes and developments which could impact Late Phase research operations.
• Organizes and leads review/approval meetings for CO proposal.
• Actively participates in 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 Client sponsored studies:
• With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.
• Assures site compliance with the routine protocol and regulatory requirements and quality of data.
• May resolve routine monitoring issues.
• Assists in the setting and updating of study timelines.
• Assists in CRO or vendor selection.
• With guidance from supervisor coordinates CROs or vendors.
• May assist in the review of protocols, informed consents, case report forms, monitoring plans, or clinical study reports.
• Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
• May participate in abstract presentations, oral presentations and manuscript development.
• Interfaces with individuals in other functional areas to address routine study issues.
• May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants.
• Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives.
• Travel is required.
Skills required demonstrating key Client core values of Integrity, Teamwork, Excellence, and Accountability
• Strong analytical, conceptual and business judgment skills.
• Excellent planning, organizational and administrative skills.
• Demonstrate core values of strong team work and accountability with ability to prioritize competing timelines and deliver excellent results while working independently
• Significant technical expertise and learning ability with demonstrated flexibility required to maintain pace with best practices in the industry
• Effective communication skills, both oral and written.
• Excellent problem solving ability.
• Effective project and time management 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 achievement of objectives and program execution.
• Good understanding of financial systems and contracting process (desirable, but not required).
• Ability to understand clinical study protocols and efficient project management skills
• Working knowledge of ICH/GCP required. Phase research experience preferred.
• Working knowledge of MS Word, PowerPoint, Outlook, and Excel.
• Working 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
• Bachelor's degree in Science with relevant project management experience, or equivalent/advanced Degree in science with relevant project management experience
• Minimum 3-5 years pharmaceutical industry experience with knowledge of drug development process.
• Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
• Ability to develop tools and processes that increase measured efficiencies of the project.
• Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
• Must have a general understanding of functional issues and routine project goals from an organizational perspective.
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