Associate Director of Clinical Operations (Hybrid) at Piper Companies

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
• Comprehensive Benefits: Medical, Dental, Vision, 401k, Paid Time Off (PTO), Holidays, sick leave as required by law, and hybrid work flexibility

Keywords:

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