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Manager, Clinical Operations

ThermoFisher Scientific

Alachua, FLJobSeen 2 days agoSeen in employer's feed 2 days ago

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At a glance

Compensation
No compensation found
Location
Alachua, FL
Work Authorization
Not specified

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Job overview

The Manager, Clinical Operations leads a team of clinical operations professionals and oversees country-level clinical trial delivery. The role covers employee development, resource allocation, training, quality oversight, performance monitoring, and process improvement. It manages team performance and operational delivery, partners with project and functional leads, and supports compliance with applicable regulatory requirements and quality expectations.

Skills & qualifications

RequiredNice to have

Skills

LeadershipCoachingPeople ManagementMentoringTeam CollaborationCommunicationInfluencingClinical Trial OperationsClinical Trial MonitoringRisk-Based MonitoringQuality ManagementICH/GCPCompany SOPs/WPDsFDA GuidelinesRegulatory RequirementsTherapeutic AreasMedical TerminologyClinical Research Data EvaluationOrganizational SkillsPlanningPrioritizationResource AllocationRisk AnticipationProblem SolvingContinuous ImprovementProcess OptimizationNegotiationDecision-MakingClinical SystemsPerformance Management ToolsComputer SkillsData EntryDocumentation ManagementInformation RetrievalEnglishTravel

Qualifications

Bachelor's Degree or Equivalent5+ Years Related Experience1+ Year Leadership ExperienceExcellent Command of English

Full job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join us as a Manager, Clinical Operations - And take on a leadership role in overseeing clinic operations, driving process improvements, managing a team of healthcare professionals, ensuring compliance with regulatory standards, and enhancing patient care and service quality.

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

What You’ll Do:

Team Leadership & Development

  • Lead, support, and develop a team of Clinical Operations professionals.

  • Manage the full employee lifecycle, including interviews, recruitment and staff

selection, onboarding, goal setting, performance management, coaching, and

career development.

  • Manage and conduct induction/orientation programs for all new employees,

ensuring their smooth integration into the company

  • Conduct structured performance and skills assessments (e.g., MAST – remote

or on-site, RAP, PAFR) to ensure high-quality study execution and continuous

growth.

  • Identify development needs, address performance concerns constructively,

and implement appropriate actions when required.

  • Review and approve time records, expenses, leave requests, and other

administrative matters in line with company policies.

  • Ensure employee documentation (CVs, training records, position and

experience profiles) remains accurate and up to date.

Study Delivery & Resource Management

  • Drive the successful delivery of clinical trials conducted at the country level.

  • Ensure team objectives and individual contributions are aligned with study

deliverables, quality expectations, and business goals.

  • Support staff allocation in line with local resourcing processes and study

priorities.

  • Partner with project and functional leads to optimize operational

performance.

  • Proactively escalate risks or issues that may impact timelines, quality, or

deliverables.

Training, Capability & Standards Oversight

  • Deliver training on SOPs, WPDs, local regulatory requirements, and other

operational topics.

  • Identify training gaps and ensure appropriate development plans are

implemented.

  • Contribute to the development and enhancement of training programs and

knowledge-sharing initiatives.

Quality & Continuous Improvemen t

  • Promote and support the implementation of risk-based monitoring principles.

  • Identify quality concerns, request Quality Assurance (QA) audits when

appropriate, and support teams in preparing audit responses.

  • Actively contribute to process improvement and operational excellence

initiatives.

Performance Monitoring & Oversight

  • Leverage applicable systems and tools to monitor KPIs, team performance,

and overall study status.

Education and Experience:

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification

  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).

  • 1+ year of leadership responsibility

Years of experience refer to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Required Knowledge, Skills, Abilities:

  • Strong leadership presence with the ability to coach, motivate, and develop high-performing teams.

  • Excellent people management, mentoring, and supervisory skills.

  • Demonstrated ability to build engaged teams and foster collaboration.

  • Strong interpersonal, communication (written and oral), 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 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 with the ability to plan, prioritize, and allocate resources effectively in a dynamic environment.

  • Proven ability to anticipate risks, solve complex problems, and escalate appropriately.

  • Continuous improvement mindset with the 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.

Policy and Strategy:

  • Interprets and administers policies, processes, and procedures that may affect sections and subordinate work units.

  • Requires full knowledge of own area of functional responsibility.

Management Role:

  • Manages a team of experienced clinical operations professionals and is accountable for overall team performance, development, and operational delivery within the assigned scope.

Physical Requirements / Work Environment:

  • Standing: Remaining on one’s feet in an upright position – Occasionally

  • Walking: Moving about on foot – Occasionally

  • Sitting: Remaining seated to perform tasks – Constantly (6-8 hours per day)

  • Repetitive Motions: Performing the same hand, finger, arm, wrist or body movement

repeatedly – Frequently

  • Talking: Expressing or exchanging information orally (Ability to communicate information and

ideas so others will understand; with the ability to listen to and understand information and

ideas presented through spoken words and sentences) – Frequently

  • Stooping/Bending: Bending the body downward and forward by bending the spine at waist –

Occasional

  • Lifting: Raising or lowering objects – E.g. luggage, laptop computer etc. (15-20 lbs) -

Occasional

  • Communication: Ability to communicate information and ideas so others will understand; with

the ability to listen to and understand information and ideas presented through spoken words

and sentences. Interacts with others to obtain or relate information to diverse groups –

Frequently

  • Travel: Required to travel for work-related tasks (including driving to site locations as well as domestic & international travel) – Frequently

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthrough.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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