Manager, Clinical Operations

Thermo Fisher Scientific • Miami, FL

23h • Onsite

About The Position

The Manager, Clinical Operations leads and oversees country-level clinical trial operations, manages a team of experienced clinical operations professionals, and is accountable for team performance, development, and operational delivery. The role supports quality patient care and service delivery by ensuring study execution aligns with operational requirements, regulatory standards, quality expectations, and business goals.

The manager oversees employee recruitment, onboarding, performance management, coaching, career development, training, administrative matters, and employee documentation. They support resource allocation and partner with project and functional leads to optimize delivery. The role also promotes risk-based monitoring, addresses quality concerns, supports audits, drives process improvement, and uses systems and tools to monitor KPIs, team performance, and study status. Travel is required, including visits to site locations and domestic and international travel.

Requirements

• Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
• Comparable to 5+ years of 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 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, including planning, prioritizing, and allocating 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 written and spoken English.
• Willingness and ability to travel as required.

Responsibilities

• Lead, support, and develop a team of Clinical Operations professionals.
• Manage the employee lifecycle, including interviews, recruitment, selection, onboarding, goal setting, performance management, coaching, and career development.
• Manage and conduct induction and orientation programs for new employees.
• Conduct structured performance and skills assessments to support high-quality study execution and continuous development.
• Identify development needs, address performance concerns, and implement appropriate actions.
• Review and approve time records, expenses, leave requests, and other administrative matters in line with company policies.
• Keep employee CVs, training records, position profiles, and experience profiles accurate and up to date.
• Drive successful delivery of clinical trials at the country level.
• 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 and 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 appropriate 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 overall study status.
• Interpret and administer policies, processes, and procedures that may affect sections and subordinate work units.

What This Job Offers

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