Piper Health and Sciences seeks a highly experienced and strategic Associate Director of Clinical Operations (Hybrid) to join a leadership team at a well-established research organization in Bethesda, MD. The Associate Director of Clinical Operations will be a senior leader responsible for overseeing and advancing our centralized monitoring processes, ensuring efficient and compliant clinical operations.
Responsibilities of the Associate Director (AD) of Clinical Operations:
Lead and oversee centralized monitoring activities across clinical trials. Ensure effective implementation and maintenance of centralized monitoring processes, including Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs). Develop and present proposals for new clinical trials. Participate in bid defense meetings to secure new projects. Collaborate with cross-functional teams to design and plan clinical studies. Ensure study designs are robust, compliant, and capable of meeting regulatory requirements. Oversee the management and maintenance of Trial Master File (TMF) and Clinical Trial Management Systems (CTMS). Prepare and present reports to senior management on clinical operations performance, including centralized monitoring metrics and study progress. Manage and oversee various clinical operations functions, including clinical project management, clinical site management), and clinical systems management. Ensure proactive identification and mitigation of risks through centralized monitoring. Review clinical trial protocols to ensure they align with centralized monitoring and reporting requirements. Provide technical guidance and oversight for central monitoring activities. Qualifications of the AD of Clinical Operations:
10+ years of experience working in clinical operations with extensive experience in centralized monitoring 5+ years of experience in a Senior Leadership position, providing oversight to various teams Bachelor's degree or Advanced degree (Master's or Ph.D.) in a related field (e.g., life sciences, clinical research). Benefits of the AD of Clinical Operations:
Salary: Between $155,000 - $175,000 annually, commensurate with experience Comprehensive Benefits: Medical, Dental, Vision, 401k, Paid Time Off (PTO), Holidays, Sick leave as required by law, and hybrid work flexibility This job opens for applications on 01/17/2025. Applications for this job will be accepted for at least 30 days from the posting date.