Manager Clinical Research Business and Regulatory Operations - Akron, OH
2 days ago
Job description
Full-time, 40 hours/week
Monday- Friday 8am-5pm
Hybrid remote, 3 days/week onsite
Summary:
The Manager, Clinical Research Business & Regulatory Operations provides strategic and operational leadership across the financial, regulatory, and systems infrastructure that supports clinical research. This role oversees clinical trial budgeting and fiscal stewardship, manages the Clinical Trial Management System (CTMS) governance and optimization, and directs regulatory documentation workflows to ensure compliance, efficiency, and high-quality execution of research activities. The manager serves as a central operational hub, aligning business processes, regulatory standards, and system functionality to support a high performing clinical research portfolio.
Responsibilities:
- Lead development, negotiation, and management of clinical trial budgets, financial tracking, and variance analysis.
- Monitor revenue, expenses, and contract alignment to ensure fiscal accuracy and financial sustainability.
- Oversee CTMS administration, configuration, optimization, and integration with financial and regulatory workflows.
- Develop and enforce CTMS governance standards, data quality processes, and user training programs.
- Direct regulatory documentation workflows, ensuring high‑quality preparation, submission, and maintenance of essential documents.
- Ensure compliance with federal regulations, ICH GCP, institutional policies, and sponsor requirements.
- Manage IRB submissions, amendments, continuing reviews, safety reporting, and document control processes.
- Lead cross‑functional coordination between clinical operations, regulatory teams, finance, investigators, and leadership.
- Drive process improvement initiatives and develop SOPs, work instructions, and training materials.
- Promote quality, compliance, audit readiness, and operational transparency by monitoring KPIs and guiding corrective actions.
Other information:
Technical Expertise
- Demonstrated experience with CTMS platforms (preferably ENCOR) and clinical trial budgeting.
- Strong knowledge of GCP, FDA regulations, and institutional research requirements.
- Leadership experience with the ability to supervise, mentor, and develop staff.
- Excellent analytical, organizational, and communication skills.
Education and Experience
- Education Bachelor of Science, healthcare, finance or related field or 10 years relevant experience, Master's degree preferred.
- Licensure: NA
- Certification: NA
- Years of relevant experience: minimum 5 years of experience in clinical research operations, regulatory affairs, research finance, or related areas.
- Years of supervisory experience Minimum 2 years
Full Time
FTE:
Status: Fixed Hybrid
Similar jobs
Manager Clinical Research Business and Regulatory Operations
Only for registered members
Full-time, 40 hours/week · Monday- Friday 8am-5pm · Hybrid remote, 3 days/week onsite · Summary · The Manager, Clinical Research Business & Regulatory Operations provides strategic and operational leadership across the financial, regulatory, and systems infrastructure that suppor ...
2 days ago
This position serves a dual role with the potential for responsibilities and assignments in both the Rates Department and Regulatory Reporting within State Finance & Regulatory organization. · This position will provide support for the development of certain rate filings and comp ...
2 weeks ago
This is an open position with the FirstEnergy Service Company.The State Regulatory Attorney works directly with business units, · department lawyers and outside counsel on regulatory matters... ...
1 month ago
Airswitf is currently recruting for a Lead Business Development to work with one of our major clients in a direct-hire contract. As the Lead Business Development, you will guide market strategy and drive growth within the Gas Distribution & Storage (GDS) industrial segment in Ohi ...
3 days ago
This position reports to the Supervisor, Compliance Field Support & Physical Security. The selected candidate may be offered a position within the same job family, at a level that is lower than what was posted. This will be determined based on the results of the interview process ...
4 weeks ago
This is an open position with the FirstEnergy Service Company. We are a forward-thinking electric utility powered by a diverse team of employees committed to making customers' lives brighter. · FirstEnergy (NYSE:) is dedicated to integrity, safety, reliability and operational exc ...
1 month ago
The company is seeking an experienced Safety & Quality Manager to lead plant-wide initiatives that ensure safe operations. · ...
1 month ago
About the RoleOur client is seeking an experienced Safety & Quality Manager to lead plant-wide initiatives that ensure safe operations, high-quality output, · a strong process discipline.You will partner closely with production, maintenance, engineering, · and leadership teams to ...
1 month ago
The Manager, Regulated Settlements leads critical financial and operational processes related to PJM market participation. · Manage the daily, monthly, and annual submission of aggregated energy, capacity, and transmission data to PJM. · Monitor compliance with Sarbanes-Oxley (SO ...
1 week ago
The Manager Regulated Settlements leads critical financial and operational processes related to PJM market participation. · Manage daily monthly and annual submission of aggregated energy capacity and transmission data to PJM ensuring accuracy and timeliness. · Monitor compliance ...
1 week ago
We are seeking a dedicated Travel Registered Respiratory Therapist in Akron OH offering exceptional respiratory care to patients in various healthcare settings Perform patient assessments administer treatments and monitor respiratory statuses Operate and troubleshoot respiratory ...
1 month ago
Job Title: Travel Nurse RN - Acute Care · Vibra Travels offers travel nursing opportunities in various locations across the country. · Benefits of working with Vibra Travels include competitive pay rates tax-free stipends no pay cuts mid-contract referral bonuses license reimburs ...
1 day ago
A world-renowned organization is seeking a Senior Associate Counsel to support its enterprise technology, digital health, and artificial intelligence initiatives. This role offers the opportunity to elevate your practice within a world-class organization. · The position reports t ...
3 weeks ago
LHH Recruitment Solutions is seeking a Food Safety Manager responsible for leading all food safety and quality programs within a USDA-regulated manufacturing environment. · ...
1 month ago
The Sterile Processing Technician is responsible for decontamination cleaning assembly and sterilization of all instruments inventory control of Sterile Processing and Operating Room supplies. · ...
1 month ago
Under the general guidance of the District Service Manager, the Service Center General Manager will lead a team of people operating in a Service Center I (large centers with 30+ employees, including Lab Pack and/or HHW and/or onsite Technical Services teams) to drive operational ...
2 days ago
The Sterile Processing Technician is responsible for decontamination, cleaning, assembly and sterilization of all instruments, · Responsible for decontamination, correct assembly and sterilization of all instruments and equipment · Responsible for inventory control of Sterile Pro ...
1 month ago
Travel MRI Tech Job - 12,318 per Month (2 Years Experience Needed)
Only for registered members
We are seeking a qualified Travel MRI Tech in Akron, OH. · Perform high-quality MRI scans adhering to safety protocols and patient care standards. · Operate MRI equipment, optimize imaging parameters, and troubleshoot technical issues. · ...
4 weeks ago
Travel MRI Tech Job - 11,871 per Month (2 Years Experience Needed)
Only for registered members
We are seeking a skilled Travel MRI Tech in Akron, · OH, · operating $11,871/month. · Perform high-quality MRI scans ensuring patient safety and comfort.Operate and maintain MRI equipment following safety protocols. · Collaborate with healthcare teams to deliver accurate imaging ...
4 weeks ago
+We are seeking a dedicated Site Chief of Neurosurgery in Akron to lead clinical operations and oversee neurosurgical services. · + · ,+Provide expert neurosurgical care, ensure quality patient outcomes, and coordinate multidisciplinary teams. · ,+,+Manage clinical staff, facilit ...
1 month ago