Sr. Manager - Clinical Trial Lead

Responsibilities Independently manage and ensure delivery of one or more clinical studies. Partner with cross-functional representatives to develop operationally feasible, robust protocol designs applying patient focus, risk management, quality, and scientific integrity; manage budget responsibility and endpoint-driven cost considerations. Develop and implement study-level operational plans, cascading key operational aspects from the Integrated Asset Plan (IAP) and Program Operational Plan (POP) to support protocol delivery. Manage day-to-day study operations to ensure successful delivery. Manage study execution activities to ensure GCP compliance, track milestones, and resolve operational risks. As a core Study Management Team (SMT) member, use available data to support informed SMT decisions and align execution with agreed strategy and plans. Support development of comprehensive clinical trial budgets reflecting all trial activity costs (patient care, research procedures, administrative expenses). What You’ll Do Chair the SMT to drive development of scientifically robust, operationally feasible protocol concepts/protocols. Collaborate with core SMT and program team members on phase/disease/therapeutic area direction aligned with IAP/POP to enable governance-approved protocol development. Evaluate study feasibility and support protocol development using operational expertise and scientific assessment. Align cross-functional perspectives to build operational plans using expertise and supporting data. Support day-to-day study operations with strong team building, clear communications, proactive risk identification/mitigation, and compliance with protocol, GCP, and regulatory guidelines. Participate in ongoing data review to mitigate patient safety, study design, data integrity, and conduct issues. Develop study budgets aligned to endpoint needs. Study Delivery / Execution Drive effective, efficient SMT operations (culture, communication, goal setting/management, strategy oversight). Ensure operational aspects support patient safety, endpoint integrity, and data validity. Demonstrate strong understanding of study design, rationale, endpoints, and patient population. Review outsourced study performance and partnership metrics to ensure milestones and deliverables. Develop project plans (e.g., Project Management Plan, Monitoring Plan, Study Risk Management Plan) and ensure required plans (e.g., Monitoring Plan, Quality Plan) are in place. Lead SMT to develop robust baseline plans for governance forums. Manage inflection points to enable course correction. Collaborate with Procurement for FMV transparency; monitor budget for overspending and cost drivers. Maintain data accuracy, completeness, and quality in study systems (e.g., Planisware, Veeva CTMS, Beacon). For outsourced studies, chair SMT with the CRO SMT Lead; ensure CRO risk mitigation plans and proactive issue identification/resolution. Process Improvement Champion best practices; seek innovation and efficiency. Identify synergies across studies/programs to enhance planning and execution. Improve and streamline processes supporting clinical trial outsourcing models. Advocate for the department and promote interaction with other teams/groups. Contribute SME expertise and promote a strong knowledge base. Required Skills / Qualifications B.A. or B. Sc. in a scientific discipline. 6+ years in clinical operations management overseeing outsourced clinical trials (quality, timeline, budget), preferably with sponsor and CRO experience. Scientific/clinical expertise; strong project management, risk assessment, contingency planning, and communication skills. Working knowledge of clinical development across one or more trial phases (I–IV) and cross-functional drug development. Expertise in Good Clinical Practices (GCP), ICH guidelines, and regulatory requirements. Ability to develop and execute operational plans supporting clinical trial delivery. Effective CRO management skills; ability to adapt to outsourcing strategies/models. Working knowledge of clinical trial financial aspects (budgeting, financial management, reporting, analysis). Benefits (as listed) Medical, Dental, Vision, & Life insurances Fitness & Wellness programs including fitness reimbursement Short- and Long-Term Disability insurance Paid vacation (minimum 15 days) and end-of-year shutdown (Dec 26–Dec 31) Up to 12 company paid holidays + 3 paid days off for Personal Significance 80 hours sick time per calendar year Paid Maternity and Parental Leave 401(k) with company matched contributions Employee stock purchase plan Tuition reimbursement up to $10,000 per calendar year Employee Resource Groups participation #J-18808-Ljbffr