Clinical Monitoring Operations Manager

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…

Clin Choice is searching for an experienced Clinical Monitoring Operations Manager to work with one of our biopharmaceutical partners. This is a full‑time, permanent position.

The Clinical Monitoring Operations Manager will be focused on alliance management, process optimization, and operational efficiency, playing a critical role in overseeing the operational execution, quality, and strategic alignment of clinical monitoring activities. This is a central liaison role between clinical trial teams and the monitoring organization.

Clin Choice is a global full‑service CRO with a strong focus on quality, professional development and supportive culture. As a client‑facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high‑trust environment with the client counterparts.

• Demonstrate strong understanding of study protocols and essential documents, including the Clinical Monitoring Plan, Investigator Brochure, ICFs and eCRFs.
• Align with Study Start‑Up and Clinical Trial Teams to coordinate Site Selection Visits, Site Initiation Visits and Close‑Out Visits.
• Serve as the primary contact for interim analysis, database locks, and major project milestones.
• Lead the monitoring operational strategy from study start‑up through to close‑out.
• Ensure monitoring deliverables progress on time, within scope and on budget.
• Oversee the design, development and maintenance of documents such as the Clinical Monitoring Plan, eCRFs, site letters, SOPs, WI’s, etc.
• Maintain an inspection‑ready TMF and ensure familiarity with the TMF Reference Model.
• Facilitate effective cross‑functional communication and drive timely issue resolution.
• Lead project meetings, managing agendas, minutes, and action item tracking.
• Create and manage monitoring‑related timelines, deliverables, and milestones.
• Track progress and provide structured updates to stakeholders.
• Identify operational risks and implement mitigation strategies.
• Conduct scenario‑based “what‑if” analyses to support planning and execution.
• Compile, analyze, and distribute monitoring metrics and reports to internal and external stakeholders.
• Establish, monitor, and improve KPIs that assess monitoring quality, efficiency, and compliance.
• Provide data‑driven insights to guide resource planning and process optimization.
• Maintain dashboards and reporting tools for transparency across teams.
• Ensure alignment with ICH‑GCP, FDA, and global regulatory requirements.
• Support audit and inspection readiness and contribute to CAPA development.

• Bachelor’s degree in business, life sciences, or related field.
• Minimum requirements include knowledge and skills developed through 5‑7 years of combined work experience in clinical research, project management, and monitoring operations. PMP certification preferred.
• Minimum 4 years managing clinical projects across full trial lifecycle.
• Deep knowledge of ICH‑GCP, FDA, and global regulatory standards.
• Proven analytical skills with expertise in monitoring data, KPIs, and reporting.
• Experience working in global, cross‑functional environments. Multi‑lingual is a plus.
• Strong communication, leadership, and organizational skills.
• Advanced proficiency with Microsoft Office, with expert‑level Excel, Word and PowerPoint skills; strong experience with Office® 365 and SharePoint.
• Proficiency in EDC, TMF, CTMS, and IRT systems.
• Demonstrated ability to solve complex problems with minimal guidance.
• Ability to mentor junior staff and begin developing people management capabilities.
• Works independently, escalating critical issues appropriately.

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not…