Clinical Trial Manager

Role Summary We are seeking a Clinical Trial Manager (CTM) to join our growing Clinical Operations team. In this newly created role, you will be accountable for the operational management and execution of global clinical trial programs (Phases I–III). Your responsibilities include ensuring adherence to GCPs, SOPs and regulatory guidelines, managing study planning and execution, partnering with CROs and other third‑party vendors to meet milestones and timelines, and maintaining data quality suitable for regulatory submission. You will regularly communicate project status, troubleshoot issues, and engage key internal and external stakeholders. Key Responsibilities Oversee study scope, quality, timelines, and budget with internal functional leads, CROs, and vendors to ensure overall project objectives are met. Initiate and build strong relationships with key opinion leaders and clinical site staff. Partner with CROs to develop and implement robust patient enrollment strategies on time and within budget for assigned regions. Partner with CROs to develop and implement robust ongoing data monitoring strategies to ensure delivery of high‑quality data. Proactively identify and manage study‑related risks. Develop and manage clinical trial documents, including protocols, case report forms (CRFs), and consents. Review and manage study‑related plans and processes including investigator agreements (CTA), site budget review, CRFs, CRF guidelines, statistical analysis plans, pharmacokinetic analysis plans, monitoring plan, data management plan, and safety monitoring plan. Collaborate with regulatory/CRO team members to assist with completion/review of regulatory submissions. Review CRO and vendor contracts/work orders and specifications to align with study objectives. Review specifications for systems build and participate in user acceptance testing (UAT) (e.g., IRT, eCOA, EDC). Participate in data cleaning and manage database lock activities with cross‑functional team. Oversee review and approval of essential document packages to enable timely site activations. Direct investigator performance and adherence to protocol, proactively addressing conduct issues and enrollment problems as necessary. Participate in TMF review and ensure quality and completeness throughout end of the study. Ensure the study is always “inspection ready.” Oversee and coach the functional activities of Clinical Trial Associates allocated to the project. Ideal Candidate Bachelor’s degree in life science or equivalent. Minimum of 5 years of clinical trial management experience in conducting international clinical trials in a sponsor pharma/biotech organization (biotech experience strongly preferred). Prior Phase II and III experience required. Solid understanding of the drug development process, ICH guidelines/GCP and specifically each step within the clinical trial process. Proven proficiency in overseeing complex studies managed in house and by a CRO. Demonstrated ability to lead teams and work in a fast‑paced, cross‑functional environment; critical and creative thinking. Experience selecting and managing clinical vendors to support study activities. Enjoys building relationships with KOLs and site personnel. Demonstrated ability to build and deliver on patient enrollment strategies. Innovative, energetic, and enthusiastic to deliver program objectives. Strong planning, time‑management, and coordination skills. Problem‑solving ability and clear judgment in relation to regulatory requirements, external interactions, timelines, and complex clinical programs. Excellent written and oral communication skills. Position requires up to 35% travel, including mandatory in‑person attendance at Apogee All Hands meetings twice per year, key Phase 3 meetings, and potentially U.S. and international travel to clinical sites and/or medical conferences. What We Offer Great culture grounded in our C.O.R.E. values: Caring, Original, Resilient, and Egoless. Opportunity to work in a fast‑paced, highly dynamic environment where you help shape culture, wear multiple hats, and learn quickly. Market‑competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare, and retirement benefits. Competitive time off, including three weeks PTO, two one‑week company‑wide shutdowns per year, and dedicated paid sick leave. Commitment to growing you professionally and providing access to resources to further your development. Apogee offers regular all‑team, in‑person meetings to build relationships and solve problems. E‑Verify participation as part of I‑9 verification of authorization to work in the U.S. Salary and Travel The anticipated salary range for this role will be $145,000–$160,000 per year. Final offer will depend on experience, education, and geography. Position requires up to 35% travel, including mandatory attendance at Apogee All Hands meetings twice per year, key Phase 3 meetings in San Francisco, and potentially U.S. and international travel to clinical sites and medical conferences. Compliance and Equal Opportunity Apogee Therapeutics is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. #J-18808-Ljbffr Apogee Therapeutics