Manager, Clinical Operations

Thermo Fisher Scientific • Miami, FL

6d • Onsite

About The Position

The Manager, Clinical Operations leads a team of experienced clinical operations professionals and is accountable for team performance, development, and operational delivery within the assigned scope. The role oversees country-level clinical trial delivery, team resource allocation, quality and regulatory compliance, training, performance monitoring, and continuous improvement. It interprets and administers policies and procedures affecting its area and works with project and functional leads to support study objectives and business goals.

The manager leads employee recruitment, onboarding, performance management, coaching, career development, and administrative processes. The role also monitors study and team performance using applicable systems and tools, addresses operational risks, and supports quality audits and risk-based monitoring. Work is primarily office-based, with travel required for work-related tasks, including site visits and domestic and international travel.

Requirements

• Bachelor's degree or equivalent and a relevant formal academic or vocational qualification.
• At least 5 years of comparable relevant experience.
• At least 1 year of leadership responsibility.
• Strong leadership presence and ability to coach, motivate, and develop high-performing teams.
• Excellent people management, mentoring, and supervisory skills.
• Ability to build engaged teams and foster collaboration.
• Strong interpersonal, written and oral communication, and influencing skills.
• Strong expertise in clinical trial operations and monitoring.
• Strong knowledge of risk-based monitoring and quality management principles.
• Comprehensive knowledge of applicable ICH/GCP, company SOPs/WPDs, FDA guidelines, and relevant regulatory requirements.
• Solid knowledge of therapeutic areas and medical terminology.
• Ability to critically evaluate medical and clinical research data.
• Strong organizational skills and ability to plan, prioritize, and allocate resources in a dynamic environment.
• Ability to anticipate risks, solve complex problems, and escalate appropriately.
• Continuous improvement mindset and ability to drive operational excellence and process optimization.
• Quality-focused, with sound negotiation and decision-making skills.
• Proficiency in clinical systems and performance management tools.
• Advanced computer skills, including data entry, documentation management, and information retrieval.
• Excellent command of English, written and spoken.
• Willingness and ability to travel as required.

Responsibilities

• Lead, support, and develop a team of Clinical Operations professionals.
• Manage recruitment and staff selection, onboarding, goal setting, performance management, coaching, and career development.
• Conduct induction and orientation programs for new employees.
• Conduct structured performance and skills assessments, including MAST, RAP, and PAFR assessments.
• Identify development needs, address performance concerns, and implement appropriate actions.
• Review and approve time records, expenses, leave requests, and other administrative matters in accordance with company policies.
• Maintain accurate and up-to-date employee documentation, including CVs, training records, and position and experience profiles.
• Drive successful country-level clinical trial delivery.
• Align team objectives and individual contributions with study deliverables, quality expectations, and business goals.
• Support staff allocation according to local resourcing processes and study priorities.
• Partner with project and functional leads to optimize operational performance.
• Escalate risks or issues that may affect timelines, quality, or deliverables.
• Deliver training on SOPs, WPDs, local regulatory requirements, and other operational topics.
• Identify training gaps and ensure development plans are implemented.
• Contribute to training program development and knowledge-sharing initiatives.
• Promote and support implementation of risk-based monitoring principles.
• Identify quality concerns, request QA audits when appropriate, and support teams in preparing audit responses.
• Contribute to process improvement and operational excellence initiatives.
• Use applicable systems and tools to monitor KPIs, team performance, and study status.
• Interpret and administer policies, processes, and procedures affecting the relevant sections and subordinate work units.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager