Position Summary

Manage the full operational execution of clinical trials for Puzzle Medical Class II and III medical devices, with primary responsibility for site management, monitoring, and inspection readiness. Responsible for end-to-end delivery of studies from Early Feasibility Studies (EFS) through pivotal trials, including hands-on monitoring in early phases and scaling clinical operations through CRA and CRO management for later-stage studies. Ensures trials are executed on time, within budget, and in compliance with ICH-GCP, ISO 14155, and applicable regulatory requirements.

Responsabilities

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

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

• Build and scale clinical operations infrastructure for pivotal trials, including hiring, training, and managing CRAs (internal and/or CRO-based).

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

• Conduct co-monitoring visits and ensure consistency and quality across monitoring activities.

• Own the development, structure, and maintenance of the eTMF, ensuring real-time completeness and inspection readiness.

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

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

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

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

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

Qualification & Experience

• Bachelor’s degree required; advanced degree preferred.

• Minimum 10+ years of experience in clinical operations within the medical device industry.

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

• Demonstrated progression into leadership of pivotal trials and clinical operations teams.

• Experience managing CRAs and CROs in global or multicenter studies.

• Strong experience with FDA-regulated trials (IDE/PMA) 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.

• Ability to operate both hands-on (EFS) and in a leadership capacity (pivotal trials).

• Proven ability to manage multiple sites, CRAs, 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 and oversight visits for pivotal studies.

• 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.