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…

ClinChoice 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 he operational execution, quality, and strategic alignment of clinical monitoring activities. This is a central liaison role between clinical trial teams and the monitoring organization.

ClinChoice 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 counter-parts.  

Main Job Tasks and Responsibilities:

• 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.
• Promote continuous improvement in monitoring processes and documentation.
• Provide consistent updates to sponsors, leadership, and study teams.
• Act as representative at meetings; facilitate CRA meetings and reporting.
• Escalate critical issues to ensure timely resolution.
• Build and maintain strong internal and external partnerships.
• Identify, track, and resolve risks and issues that may impact monitoring operations.
• Ensure efficient escalation pathways and timely mitigation.

Education, Experience and Skills:

• 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.
• Strong collaborator with excellent stakeholder and relationship management skills.
• Highly detail-oriented with a commitment to accuracy and compliance.
• Skilled in project planning and reporting technologies.
• Analytical thinker with strong problem-solving abilities.

The Application Process

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 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 successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Key words: Clinical Monitoring Operations Manager, Site Engagement, Monitoring Excellence, Freelance, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated