Senior Manager, Clinical Operations Quality Compliance

Job Description
Bicycle Therapeutics, Inc. is seeking a knowledgeable, resourceful and collaborative Clinical Quality Compliance Manager within Clinical Operations. The Senior Manager, Clinical Operations Quality Compliance collaborates with Clinical Operations, Clinical Quality, Clinical Development, Medical Affairs, Safety, and other functions to help maintain compliance with processes, ensure regulatory compliance and promote the highest standards of quality and integrity in Clinical Operations. They will support delivery of Clinical Operations activities by participating in Clinical Operations process improvement and development and supporting implementation of function-wide initiatives. They will lead investigations of GCP quality issues and ensure effective risk mitigations are established. In addition, they will support the oversight of Clinical Operations processes, training, and inspection readiness activities and tools and participate in regulatory inspection activities
Provide ICH/GCP clinical compliance support to Clinical Operations and their stakeholders. Maintain current knowledge related to ICH/GCP guidelines and regulations and Bicycle standard operating procedures.
Collaborate and develop strong relationships with personnel from Clinical Operations, Clinical Quality, and other cross functional stakeholders to facilitate and support process improvement, risk management, and inspection readiness activities.
Collaborate with Clinical Quality to ensure that Clinical Operations written standard operating procedures, forms, and templates reflect appropriate business practices and meet the changing needs of the organization.
Establish standards for excellence in GCP investigation documentation, inspection preparation and responses, CAPAs, and effectiveness checks to optimize effective and consistent performance. Assist with resolution of quality events, deviations, audit and inspection findings.
Support the clinical operations team in root cause analysis and facilitating closure/evidence of completion of assigned Clinical Operations corrective action commitments;
confirm that all actions and commitments related to inspections are implemented in accordance to plan and support effectiveness checks
Support Clinical Operations initiatives (including lessons learned process) to develop innovative processes and technologies to advance compliant operations
Facilitate and support inspection readiness activities in Clinical Operations
Provide support before, during and following regulatory inspections and internal audits involving clinical operations
Identify and escalate significant quality and compliance risks to leadership within Clinical Operations, Clinical Development and Clinical Quality.
Participate in due diligence activities and process improvement initiatives as requested by management
Other duties and responsibilities as required