Summary:
The Lead Specialist Clinical Operations plays a pivotal role in driving our growth and profitability by leading the planning and execution of complex clinical studies. This senior role involves enhanced responsibility for leadership and oversight of clinical operations, ensuring compliance with Sponsor SOPs, Good Clinical Practice, and other relevant clinical research regulations and guidelines including but not limited to FDA Code of Federal Regulations, ISO, and MDCG. The Lead Specialist Clinical Operations serves as a resource and mentor within the Global Clinical Affairs (GCA) department. Role will regularly collaborate with GCA study team members (Clinical Project Management, Biostatistics, Data Management, Clinical Scientist) and cross-functional team members (Regulatory, Quality, R&D, and others). Develops working relationships with and acts as the primary contact for study Investigators, Site Research Staff, ethics committees, and regulatory authorities.
Responsibilities:
Clinical Study Operations Leadership
- Acts as a member of the GCA study team and contributes strategic input on protocols and supporting essential study documentation as it relates to clinical operations, recruitment, and compliance topics.
- Develops and maintains strategic relationships with key external stakeholders to optimize clinical trial performance. Represents the company at major scientific meetings and contributes to scientific presentations and publications.
- Manages ethics submissions, correspondence, and close out. Responsible for coordinating with relevant GCA study team members to address queries within the required timeframe.
- Leads study recruitment, retention, and compensation efforts.
- Responsible for shipment of study devices and supplies to clinical sites and/or subjects. Also responsible for maintaining study device accountability throughout each study (initial, interim, and final).
- Oversees management of the GCA study product lab.
Clinical Study Compliance Oversight
- Leads the collection and storage of all required eTMF documents as required by Site, Sponsor, and/or CRO.
- Oversees eTMF internal processes are followed and leads GCA in conducting periodic internal review audits to ensure inspection readiness.
- Oversees study research staff and study progress to ensure protocol procedures are adhered, are complete, and maintain compliance with regulatory standards.
Advanced Site/Investigator Management
- Directs the operational aspects of assigned studies, implementing strategies to enhance site performance and compliance. Provides advanced training to site staff, oversees critical safety and efficacy trend analyses, and ensures rigorous adherence to protocol and GCP.
- Oversees contract development and negotiations for clinical sites, investigators, CROs, and other study vendors.
- Manages investigators, clinical sites, CRO, and other study vendor relationships.
- Leads clinical site and investigator pre-study qualification and re-qualification audits.
- Leads on-site and remote site monitoring visits (selection/qualification, initiation, interim, and close-out) to evaluate compliance in accordance with contracted scope of work and regulatory requirements.
- Completes monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies, and recommended action to secure compliance. Escalates issues.
Process Improvement
- Responsible for leading process improvements within clinical operations, ensuring compliance with relevant guidelines and contributing to the development and updating of clinical SOPs.
Mentorship and Training
- Provides guidance and professional development support to junior Clinical Operations staff, fostering professional growth within the team.
Essential Functions of the Role:
- Excellent oral communication skills, communication skills, and problem solving.
- Must be able to travel up to 25% of the time. Must maintain current driving license and passport.
Work Experience Requirements
- Number of Overall Years Necessary: 8-12
- Minimum of 4 years of clinical research monitoring experience.
- Extensive experience with clinical research studies and clinical operations tasks.
- Prior experience managing ethics submissions is required.
Education Requirements
- B.S. or B.A. degree in a scientific field.
- CRA certification preferred.
- Minimum of 4 years of clinical research monitoring experience.
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
Specialized Skills/Technical Knowledge:
- Expertise in clinical research processes, including comprehensive knowledge of FDA CFR, Good Clinical Practices, ICH, ISO, and MDCG.
- Proficiency in Microsoft Office Suite and project management tools.
- Advanced knowledge in medical device clinical research, particularly in areas such as wound care, ostomy, critical care, and/or continence care.
