Clinical Trial Data Program Manager
Job Description
At Cleveland Clinic Health System, we believe in a better future for healthcare. And each of us is responsible for honoring our commitment to excellence, pushing the boundaries and transforming the patient experience, every day.
We all have the power to help, heal and change lives — beginning with our own. That’s the power of the Cleveland Clinic Health System team, and The Power of Every One.
Job Title
Clinical Trial Data Program Manager
Location
Cleveland
Facility
Cleveland Clinic Main Campus
Department
HVTI Research and Registries-Heart Vascular & Thoracic Institute
Job Code
T31030
Shift
Days
Schedule
8:30am-5:30pm
Job Summary
Job Details
Join Cleveland Clinic’s Main Campus where research and surgery are advanced, technology is leading-edge, patient care is world class and caregivers are family. Here, you will work alongside a passionate and dedicated team, receive endless support and appreciation, and build a rewarding career with one of the most respected healthcare organizations in the world.
The Lead Clinical Trial Data Program Manager is responsible for leading and overseeing all clinical data management activities to ensure the accurate, consistent, and high-quality collection, processing, analysis, and reporting of clinical trial data. This role ensures compliance with Good Clinical Practice (GCP), applicable regulatory requirements, including 21 CFR Part 11 and HIPAA, and organizational standards.
The Lead Clinical Trial Data Program Manager provides strategic leadership for data management operations, overseeing a team of data managers and database developers while fostering a culture of quality, collaboration, and continuous improvement. Working closely with Clinical Operations, Biostatistics, Quality Assurance, and other cross-functional stakeholders, this individual drives the development and execution of data management strategies, database design standards, process optimization initiatives, and data governance practices to support successful clinical trial execution and regulatory submissions.
A caregiver in this position works Mon-Fri| 8:00am—5:00pm| hybrid: in office 2 days per week.
A caregiver who excels in this role will:
Develop, implement, manage, and maintain operational systems and activities.
Serve as a liaison with all levels of the organization and outside the community.
Manage multiple priorities and projects with competing deadlines.
Allocate time to meet completion requirements.
Serve as a coach and mentor for other positions in the department.
Review and monitor adherence to Human Resources policies and corporate compliance procedures.
Oversee end-to-end data management activities from
database design through database lock.
Ensure eCRF design and data collection comply with
protocol, and regulatory requirements.
Review and approve critical deliverables such as data
management plans (DMPs), edit check specifications,
test scripts, and data validation reports.
Ensure adherence to 21 CFR Part 11–compliant
systems
Manage issue escalation and resolution across data
queries, discrepancies, and protocol deviations.
Drive continuous improvement and standardization of
processes and templates.
Ensure data integrity, security, and traceability across
all studies
Other duties as assigned.
Minimum qualifications for the ideal future caregiver include:
Bachelor's Degree in Business Administration, Healthcare Administration or related field and 5 years of related experience
OR Master’s degree and 4 years of experience
Knowledge of statistical and financial analysis, primary research and business plan development
Strong presentation, communication and training skills
Preferred qualifications for the ideal future caregiver include:
Master’s Degree
Healthcare settings
Physical Requirements:
- Ability to communicate and exchange accurate information.
- Ability to perform work in a stationary position for extended periods.
- Ability to work with physical records or operate a computer or other office equipment.
- In some locations, ability to travel throughout the hospital system.
- In some locations ability to move up to 25 lbs.
Personal Protective Equipment:
- Follows Standard Precautions using personal protective equipment as required for procedures.
The policy of Cleveland Clinic Health System and its system hospitals (Cleveland Clinic Health System) is to provide equal opportunity to all of our caregivers and applicants for employment in our drug free environment. All offers of employment are followed by testing for controlled substances.
Cleveland Clinic Health System administers an influenza prevention program. You will be required to comply with this program, which will include obtaining an influenza vaccination on an annual basis or obtaining an approved exemption.
Decisions concerning employment, transfers and promotions are made upon the basis of the best qualified candidate without regard to color, race, religion, national origin, age, sex, sexual orientation, marital status, ancestry, status as a disabled or Vietnam era veteran or any other characteristic protected by law. Information provided on this application may be shared with any Cleveland Clinic Health System facility.
If applying for a Florida position, please see the following website for more information on the background screening requirements required by the Agency of Health Care Administration: https://info.flclearinghouse.com/
Please review the Equal Employment Opportunity poster.
Cleveland Clinic is pleased to be an equal employment opportunity employer.