Job Title: Clinical Operations Manager – Clinical Trials
Job Description
This role manages and coordinates clinical trials in alignment with trial protocols, FDA regulations, and ICH/GCP guidelines. The Clinical Operations Manager oversees workflows, processes, clinical study coordinators, and data support teams across multiple therapeutic areas, with a strong focus on patient-facing activities. The position partners closely with business development teams and Study Intake Program Managers to ensure research projects are high quality, operationally feasible, and responsive to the needs of investigators and patients. The role is accountable for meeting accrual metrics and execution timelines and works horizontally with Core Managers and facility leaders to deliver seamless clinical trial execution. Through collaboration with the Office of Sponsored Programs, Office of Research Integrity, and the Institutional Review Board (IRB), this position ensures smooth, compliant, and ethically sound clinical research operations.
Responsibilities
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Manage and coordinate clinical trials in accordance with trial protocols, FDA regulations, and ICH/GCP guidelines.
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Oversee workflows, processes, clinical study coordinators, and data support teams for patient-facing aspects of clinical trials across multiple therapeutic areas, including oncology and Phase I oncology.
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Collaborate with business development teams and Study Intake Program Managers to ensure research projects are high quality, operationally feasible, and aligned with investigator and patient needs.
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Meet clinical trial accrual metrics and execution timelines by working closely with Core Managers and facility leaders.
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Provide daily management, annual evaluations, coaching, and mentorship to clinical study coordinators and data teams to support long-term team sustainability.
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Develop and implement approaches to monitor and evaluate the quality of clinical operations, ensuring continuous improvement.
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Work with regulatory specialists to implement steps necessary to maintain compliance with external regulatory agencies and internal policies.
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Manage the delivery of safe, patient-centered care with respect for the dignity and rights of all research participants.
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Plan, organize, and manage all activities related to clinical research operations, ensuring effective and compliant study coordination across multiple therapeutic areas.
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Collaborate with Research Services, Study Intake, Portfolio Management, and clinical study coordinators to develop study budgets for all research projects within supported therapeutic areas.
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Partner with the Senior Clinical Operations Manager and Core Managers to design and implement processes that optimize workflow and scheduling for clinical operations.
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Work collaboratively with peer Clinical Operations Managers to resource and staff all projects within the portfolio, including studies outside of primary therapeutic areas.
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Provide leadership for research participant recruitment, data entry, and data management, ensuring optimal recruitment strategies and standardization across research teams.
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Perform managerial duties related to the selection, onboarding, supervision, development, and appraisal of research staff.
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Collaborate with other research departments to ensure compliance with federal, state, local, and institutional regulations and policies.
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Assist in establishing and maintaining Standard Operating Procedures (SOPs) for clinical operations, research training, and staff certification.
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Assess situational needs and stakeholder input to make informed staffing and resourcing decisions that drive optimal research participant enrollment and timely trial completion.
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Ensure that clinical operations adhere to best practices in clinical research, including documentation, data quality, and participant safety.
Essential Skills
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10+ years of experience as a lead research coordinator or research manager with increasing people management responsibilities.
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5+ years of experience as a research nurse/registered nurse or non-nurse coordinator in a healthcare setting or research site.
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5+ years of experience in a healthcare or research setting with demonstrated experience managing teams.
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Proven ability to manage and coordinate clinical trials in compliance with FDA regulations and ICH/GCP guidelines.
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Demonstrated experience in clinical operations and clinical research, including oncology and Phase I oncology.
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Strong project management skills, including planning, organizing, and executing clinical research timelines.
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Experience overseeing clinical study coordinators and data support teams in a patient-facing research environment.
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Ability to collaborate effectively with cross-functional teams, including business development, Study Intake, Portfolio Management, and regulatory specialists.
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Demonstrated capability to develop, monitor, and improve clinical operations workflows and processes.
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Strong leadership skills in staffing, resourcing, scheduling, and performance management of clinical research teams.
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Proficiency in ensuring regulatory compliance and working with offices such as Sponsored Programs, Research Integrity, and IRBs.
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Excellent communication, stakeholder management, and problem-solving skills.
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Bachelor’s degree in Healthcare Administration, Business, or a related field.
Additional Skills & Qualifications
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Master’s degree in Healthcare Administration, Business, or a related field is preferred.
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7+ years of experience as a research nurse/registered nurse or non-nurse coordinator in a healthcare setting or research site is preferred.
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Demonstrated experience staffing, resourcing, and scheduling clinical study coordinator and data teams to support a diverse portfolio of research studies is preferred.
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Experience leading research operations across multiple therapeutic areas, including oncology and Phase I oncology.
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Registered Nurse (RN) license is preferred.
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Basic Life Support (BLS) – CPR certification is preferred.
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Certified Clinical Research Coordinator (CCRC) certification is preferred.
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Membership or certification through the Association of Clinical Research Professionals (ACRP) is preferred.
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Membership or certification through the Society of Clinical Research Associates (SOCRA) is preferred.
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Experience establishing and maintaining Standard Operating Procedures (SOPs) for clinical operations and research training.
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Ability to interpret and apply federal, state, local, and institutional regulations to clinical research operations.
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Strong organizational skills and attention to detail in managing complex clinical trial portfolios.
Work Environment
The role is primarily onsite at a clinical research facility located at the Celebration site, with one day per week based at a corporate research office in downtown Orlando. The work environment involves close collaboration with clinical research teams, including clinical study coordinators, data support staff, and cross-functional partners such as Research Services, Study Intake, Portfolio Management, and regulatory offices. The position operates within a structured clinical research setting that emphasizes compliance with FDA, ICH/GCP, and institutional standards. The environment is fast-paced and deadline-driven, requiring coordination across multiple therapeutic areas and concurrent research studies. Professional attire appropriate for a clinical and corporate research setting is expected, and the role involves regular interaction with patients, investigators, and internal stakeholders to support safe, high-quality clinical trial execution.
Job Type & Location
This is a Permanent position based out of Kissimmee, FL.
Pay and Benefits
The pay range for this position is $120000.00 - $140000.00/yr.
Benefits from Day One: Medical, Dental, Vision Insurance, Life Insurance, Disability Insurance Paid Time Off from Day One 403-B Retirement Plan 4 Weeks 100% Paid Parental Leave Career Development Whole Person Well-being Resources Mental Health Resources and Support Pet Benefits
Workplace Type
This is a fully onsite position in Kissimmee,FL.
Application Deadline
This position is anticipated to close on Jul 31, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
