Director Clinical Operations for USA

Application Deadline: Until we have found the right profile

Company Description

GCRI is dedicated to delivering scientifically robust, regulatory-compliant clinical trials with strong operational governance in wound healing, dermatology, orthopedics, and related therapeutic areas. We design and conduct clinical trials and clinical investigations in accordance with applicable US and European regulatory requirements, GCP, relevant international standards, and applicable national requirements.

Our mission is supported by a highly trained workforce, a strong SOP-driven quality framework, and a commitment to scientific integrity, ethical study conduct, and reliable data generation. Through rigorous methodology, effective collaboration with investigators and sponsors, and robust governance and infrastructure, GCRI aims to advance high-quality clinical research that improves patient outcomes and strengthens industry confidence.

Role Description

You provide senior operational and quality leadership across all GCRI-supported clinical trials in the US, ensuring that operational functions, systems, processes, and vendors support high-quality, compliant, efficient, and timely clinical trial delivery.

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

The Director Clinical Operations works closely with and supports the CMO in the execution of site management, monitoring, and other clinical trial activities by ensuring that appropriate operational processes, systems, documentation, resources, quality controls, and escalation pathways are in place and functioning effectively.

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

Initially, this will be a part-time, remote role of approximately 20-30 hours per week, with the expectation that it will transition to a full-time position within the next few months.

You will join an international team, with colleagues from Denmark, UK, USA, Spain and Switzerland. The applicant should be based in USA.

Duties and Responsibilities

• Provide senior operational leadership and direction across GCRI clinical trials, ensuring 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 to ensure cohesive, efficient, and compliant study delivery.

• Ensure appropriate operational plans, processes, systems, resources, controls, and escalation pathways are established and maintained throughout the clinical trial lifecycle, from study start-up through conduct, data delivery, close-out, and archival.

• Ensure clinical trials conducted in the United States are operationally supported in accordance with applicable regulatory, ethical, GCP, quality, and study-specific requirements. This includes appropriate operational governance of FDA-regulated pre-market/pre-approval and post-market/post-approval studies, as applicable.

• Support the CMO in the execution of site management and monitoring activities by ensuring appropriate operational processes, monitoring plans and tools, systems, documentation requirements, resources, communication pathways, escalation mechanisms, and quality controls are established and maintained. Ensure the operational compliance, consistency, documentation quality, and timely follow-up of monitoring activities.

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

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

• Lead and oversee GCRI Quality activities, including QMS oversight, training compliance, internal audits, quality issue management, CAPA management, protocol deviation processes, vendor quality oversight, inspection readiness, and continuous quality improvement.

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

• Oversee the operational components of safety workflows, ensuring appropriate processes for timely collection, documentation, reconciliation, reporting, tracking, and escalation of safety information.

• Manage operational budgets, resource planning, capacity, and forecasting across GCRI-supported studies, ensuring efficient allocation of internal and external resources and timely identification of scope, budget, or resource changes.

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

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

• Support the CMO in the development, refinement, implementation, and continuous improvement of operational and quality processes and SOPs.

• Promote a culture of operational excellence, quality, accountability, collaboration, professional development, and continuous improvement across GCRI operational functions.

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’ experience in clinical operations, including significant experience within a CRO environment and demonstrated success in senior clinical operations leadership. Must have substantial hands-on experience in the operational delivery of clinical trials in both the United States and Europe, including FDA-regulated pre-market/pre-approval and post-market/post-approval studies, as applicable, and European clinical trials or clinical investigations conducted in accordance with relevant regulatory requirements.

Demonstrated experience overseeing clinical trial operations, Quality, Data Management, vendor management, regulatory compliance, operational risk management, and audit and inspection readiness is required. Strong experience working in wound care clinical trials highly desirable.

Skills

Strong operational leadership, governance, decision-making, and problem-solving skills. Demonstrated ability to manage multiple clinical programs, maintain visibility across functions, identify and manage operational and quality risks, and support organizational scalability. Excellent communication, sponsor management, resource planning, budgeting, risk management, process optimization, and cross-functional leadership abilities.

Language

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

Travel

Travel to US clinical sites, vendors, internal teams, audits, investigator meetings, or sponsor meetings up to 30%. Occasional travel to Europe may be required.

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

We are looking forward to your application.