About GCRI

GCRI is focused on delivering scientifically robust, regulatory-compliant clinical trials with strong operational governance across wound healing, dermatology, orthopaedics and related therapeutic areas.

The organisation conducts clinical trials and clinical investigations in accordance with applicable U.S. and European regulatory requirements, Good Clinical Practice (GCP), relevant international standards and applicable national requirements.

GCRI's operations are supported by a highly trained workforce, an SOP-driven quality framework and a commitment to scientific integrity, ethical study conduct and reliable data generation. The company works with investigators and sponsors through rigorous methodology, collaboration, governance and operational infrastructure.

The Role

The Director, Clinical Operations will provide senior operational and quality leadership across GCRI-supported clinical trials in the United States.

The role is responsible for the operational framework supporting studies from start-up through conduct, data delivery, close-out and archival. This includes study management, operational compliance, Quality, Data Management, resource and budget management, clinical systems, vendor oversight, and audit and inspection readiness.

The Director will work closely with and support the Chief Medical Officer in the execution of site management, monitoring and other clinical trial activities by ensuring appropriate operational processes, systems, documentation, resources, quality controls and escalation pathways are established and functioning effectively.

The role requires substantial experience delivering clinical trials in both the United States and Europe, including FDA-regulated pre-market/pre-approval and post-market/post-approval studies, as applicable.

The position will initially be part-time and remote at approximately 20–30 hours per week, with the expectation of transitioning to full-time within the next few months.

Key Responsibilities

Clinical Operations Leadership

• Provide senior operational leadership and direction across GCRI clinical trials.
• Ensure timelines, quality standards, budgets, contractual commitments and applicable regulatory requirements are consistently met.
• Lead, mentor and support Clinical Trial Management, Data Management, Quality and other assigned operational personnel.
• Establish and maintain operational plans, processes, systems, resources, controls and escalation pathways throughout the clinical trial lifecycle.
• Support operational delivery from study start-up through conduct, data delivery, close-out and archival.

Regulatory & Clinical Compliance

• Ensure U.S. clinical trials are operationally supported in accordance with applicable regulatory, ethical, GCP, quality and study-specific requirements.
• Provide operational governance for FDA-regulated pre-market/pre-approval and post-market/post-approval studies, as applicable.
• Maintain inspection readiness across clinical operations and quality functions.

Site Management & Monitoring

• Support the Chief Medical Officer in site management and monitoring activities.
• Ensure monitoring plans, tools, systems, documentation requirements, resources, communication pathways, escalation mechanisms and quality controls are established and maintained.
• Ensure monitoring activities are operationally compliant, consistent, well documented and followed up in a timely manner.

Data Management

• Lead and maintain oversight of Data Management activities.
• Oversee data entry, data quality processes, CRF design, database development, reconciliation workflows, data review, query management, data cleaning and database lock.

Quality Management

• Lead and oversee GCRI Quality activities.
• Maintain QMS oversight and training compliance.
• Manage internal audits, quality issues, CAPA, protocol deviations and vendor quality oversight.
• Maintain inspection readiness and drive continuous quality improvement.

Documentation & Records

• Ensure completeness, accuracy, contemporaneous maintenance and inspection readiness of the Trial Master File, Investigator Site File processes and other essential study records.

Vendor Management

• Lead vendor qualification, selection, contracting, onboarding, oversight and performance management.
• Ensure vendors and service providers meet GCRI's operational, quality, contractual and regulatory expectations.

Safety & Risk Management

• Oversee operational components of safety workflows.
• Ensure timely collection, documentation, reconciliation, reporting, tracking and escalation of safety information.
• Identify and manage operational and quality risks across supported studies.

Budget & Resource Management

• Manage operational budgets, resource planning, capacity and forecasting.
• Ensure efficient allocation of internal and external resources.
• Identify scope, budget and resource changes in a timely manner.

Sponsor & Business Support

• Serve as the senior operational point of contact for sponsors.
• Provide visibility into study progress, operational performance, timelines, risks, quality issues, resources and delivery against commitments.
• Provide operational input into proposals, budgets, feasibility assessments, bid-defence activities, scopes of work and change orders.

Audit & Inspection Readiness

• Maintain operational and quality readiness for sponsor audits and regulatory authority inspections.
• Coordinate documentation, systems, processes, staff preparation, responses, corrective actions and follow-up.
• Support the Chief Medical Officer where clinical, scientific, GCP or site-related input is required.

Process Improvement

• Support the Chief Medical Officer in the development, refinement, implementation and continuous improvement of operational and quality processes and SOPs.
• Promote operational excellence, quality, accountability, collaboration, professional development and continuous improvement.

Qualifications

• Bachelor's or Master's degree in life sciences, clinical research, healthcare administration or a related field.
• Advanced qualifications in project management, quality management, regulatory affairs or a related discipline are an asset.

Experience

• Minimum 10 years of experience in clinical operations.
• Significant experience within a CRO environment.
• Demonstrated success in senior clinical operations leadership.
• Substantial hands-on experience delivering clinical trials in both the United States and Europe.
• Experience with FDA-regulated pre-market/pre-approval and post-market/post-approval studies, as applicable.
• Experience with European clinical trials or clinical investigations conducted under relevant regulatory requirements.
• Demonstrated experience overseeing Clinical Trial Operations, Quality, Data Management, vendor management, regulatory compliance, operational risk management and audit and inspection readiness.
• Strong experience in wound care clinical trials is highly desirable.

Skills

• Strong operational leadership, governance and decision-making skills.
• Strong problem-solving and risk-management capabilities.
• Ability to manage multiple clinical programmes and maintain visibility across functions.
• Ability to identify and manage operational and quality risks.
• Excellent sponsor management and communication skills.
• Strong resource planning and budgeting abilities.
• Process optimisation and cross-functional leadership experience.
• Ability to support organisational scalability.

Language

• Fluency in English with strong written and verbal communication skills.
• Additional languages are an asset.

Work Arrangement & Travel

The role is based remotely in the United States.

Travel to U.S. clinical sites, vendors, internal teams, audits, investigator meetings or sponsor meetings may be required up to 30%, with occasional travel to Europe.

The successful candidate will join an international team spanning Denmark, the UK, the USA, Spain and Switzerland.

Application Process

Applications will remain open until the right candidate has been found.

For questions, contact Dr. Mark Cregan, Chief Medical Officer, via markc@gcri-cro.com or LinkedIn.

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