Position Summary

Manage the full operational execution of clinical trials for Puzzle Medical Class III medical devices, with primary responsibility for site management, monitoring, and inspection readiness. Responsible for end-to-end delivery of Early Feasibility Studies (EFS), acting as the primary CRA and performing all monitoring activities hands-on. Ensures trials are executed on time, within budget, and in compliance with ICH-GCP, ISO 14155, and applicable regulatory requirements.

Responsibilities

• Lead operational execution of clinical studies from SQV through close-out, including site selection, activation, enrollment, and monitoring.

• Perform monitoring activities for EFS studies, including SQVs, SIVs, IMVs, and COVs, acting as the primary CRA.

• Oversee and optimize site activation timelines, including feasibility, contracts, budgets, and IRB/EC approvals.

• Manage site performance, enrollment, and compliance; proactively identify and mitigate risks.

• Establish and execute risk-based monitoring strategies and ensure high-quality source data verification (SDV).

• Own the development, structure, and maintenance of TMFs and/or eTMFs, ensuring real-time completeness and inspection readiness.

• Define, create and implement TMF/eTMF processes, quality control procedures, and documentation standards.

• Drive data quality, query resolution, and protocol compliance to support timely database lock.

• Lead TMF reviews and support internal and external audits and regulatory inspections.

• Partner cross-functionally with Regulatory, Clinical, and Quality to ensure aligned execution.

• Identify operational risks and implement mitigation strategies; escalate critical issues with proposed solutions.

Qualifications & Experience

• Bachelor's degree required; advanced degree preferred.

• 5+ years of experience in clinical operations within the medical device industry.

• Proven experience with hands-on clinical monitoring (CRA-level).

• Experience working in multicenter studies.

• Strong experience with FDA-regulated trials (IDE) and/or international studies.

• Experience with BIMO audits.

Knowledge & Skills

• In-depth knowledge of ICH-GCP and ISO 14155.

• Strong understanding of the full clinical trial lifecycle (SQV → activation → monitoring → close-out).

• Expertise in risk-based monitoring methodologies.

• Comprehensive understanding of eTMF structure, documentation standards, and inspection readiness requirements.

• Familiarity with EDC systems and clinical data workflows.

• Strong execution focus with high attention to detail.

• Proven ability to manage multiple sites and vendors simultaneously.

• Excellent problem-solving and risk mitigation capabilities.

• Strong organizational and project management skills.

• Effective communication and stakeholder management across cross-functional teams.

• Ability to work in fast-paced, high-accountability environments.

Work Conditions

• Travel required (approximately 20–30%), including frequent on-site presence for EFS monitoring.

• Combination of office-based and field-based work.

• High level of accountability for study timelines, quality, and regulatory compliance.

• Role may require flexibility to support critical study milestones and site needs.

At Puzzle, we value our employees and offer a comprehensive benefits package

• Comprehensive group benefits including medical, dental, and vision coverage;

• Virtual healthcare access for you and your immediate family (Dialogue);

• 2 sick days + 3 personal days to support your work-life balance;

• 50% reimbursement on gym memberships to support your well-being;

• 3 weeks of vacation + Paid holiday closure in December so you can fully enjoy the festive season;

• Employee referral bonus program;

• Free coffee to keep you energized;

• Regular team activities and social events to foster a collaborative and fun work environment.