Manager
Senior-Clinical Trial Manager Full-time
Repare Therapeutics (Nasdaq: RPTX) is a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. The Company utilizes its genome-wide, CRISPR-enabled SNIPRx® platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The Company’s pipeline includes its lead product candidate RP-3500, a potential leading ATR inhibitor, as well as a CCNE1-SL inhibitor and Polθ inhibitor programs. Repare is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives. We are seeking a Clinical Trial Manager/Senior Clinical Trial Manager with the passion and desire to become part of a fast-based, innovative team committed to developing breakthrough cancer therapies. The individual will be a self-starter that is effective in working independently as well as a collaborative team member. The successful candidate will ensure the Company’s clinical trial(s), in support of its innovative clinical pipeline, are managed to the highest quality to ensure safety and effectiveness of products in adherence with all applicable regulations. RESPONSIBILITIES Leads cross-functional trial team to ensure delivery of complex clinical trials and manages protocol execution. Oversees CROs and vendors to ensure timelines, goals and deliverables are met with quality, within budget, and in accordance with SOPs, GCP and all applicable laws and regulations. Provides input to the clinical development plan and operational aspects of the clinical trial protocol (e.g., develops and/or reviews operational plans for trials). Prepares/reviews site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments). Identifies and/or anticipates operational risks and mitigation plans within assigned clinical trials and escalates issues and recommends contingency plans to Head of Clinical Operations as necessary. Establish study milestones and ensure accurate tracking and reporting of study metrics, timelines, update of trial information in all trial databases and tracking systems. Provide monitoring oversight including authoring of oversight plan, reviewing monitoring visit reports and perform periodic oversight visits to sites and/or vendors to assess progress and compliance. Manage clinical trial budgets, providing ongoing financial reporting and projections to the finance group and facilitate the development of clinical trial agreements, insurance and other relevant documents in conjunction with legal. Ensure the Trial Master File (TMF) is maintained throughout the trial and performs inspection readiness checks throughout the lifecycle of the trial. Serves as functional area reviewer of global clinical / regulatory submissions. Present study status reports of operational execution activities to senior management. Provide study specific mentor and training for in-house Clinical Research Associate(s). Participates in operational process improvement initiatives (including, training, SOP review and development of work instructions/tools/templates). Performs other duties as assigned QUALIFICATIONS Bachelor’s degree in a life science or a health-related field is preferred, Advanced degree highly preferred Five (5) years or more of progressive clinical management experience with the biotech / pharmaceutical industry or in a clinical research organization (oncology experience highly preferred), global trial experience highly preferred Solid understanding of the clinical trial database life cycle including, data collection, review and analysis, CRF design, database development and testing, discrepancy management, data quality review and database close and lock procedures Strong understanding of FDA/ICH guidelines and industry standard practices regarding clinical trial management Excels in a fast-paced, high-growth company environment with minimal direction and a high-degree of independence and able to adjust workload based on changing priorities Collaborative team player who is also an independent thinker; ability to develop a strong point of view combined with the openness to evolving that view based on new data and analysis Excellent communication skills. Ability to communicate in an open, clear, timely and consistent manner Ability to handle multiple projects and utilize judgement to prioritize tasks Ability to contribute as a team member in a dynamic, fast-paced biotech environment