Clinical Trial Manager
- Remote
- Contract
About the role
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Trial Manager based in the United States.
As a Clinical Trial Manager, you will lead and oversee clinical research operations across multiple studies, ensuring high standards of quality, regulatory compliance, and patient safety. You will manage the full clinical trial lifecycle, from feasibility assessments and study start-up to execution, monitoring, and closeout activities. Working closely with Principal Investigators, Sponsors, CROs, and clinical teams, you will ensure studies are delivered efficiently and in accordance with applicable regulations. You will also oversee research staff, budgets, recruitment strategies, and operational performance. This role offers the opportunity to shape and strengthen a growing clinical research program while contributing to meaningful medical research. It is a remote, US-based position with periodic travel to clinical sites, particularly in the Midwest.
Accountabilities:
As Clinical Trial Manager, you will be responsible for the end-to-end management of clinical research activities, ensuring operational excellence, regulatory compliance, and effective coordination across all stakeholders. Your main responsibilities will include:
- Study Start-Up and Feasibility
Evaluate new clinical studies with Principal Investigators (PIs), assessing protocol feasibility, patient populations, staffing requirements, equipment, and facilities.
Complete Sponsor and CRO feasibility questionnaires and participate in pre-study and site qualification visits.
Prepare and submit Institutional Review Board (IRB) applications, informed consent forms, amendments, continuing reviews, and safety reports.
Coordinate Clinical Trial Agreement (CTA) and Confidentiality Agreement reviews with clinic leadership and legal counsel.
Develop and negotiate study budgets, including per-patient costs, start-up fees, and pass-through expenses.
Lead site initiation visits and ensure all necessary approvals, training, and supplies are in place before activating studies.
- Study Conduct and Oversight
Oversee the daily execution of active clinical studies, ensuring compliance with protocols, Good Clinical Practice (GCP), FDA regulations, HIPAA, and clinic policies.
Manage participant recruitment, screening, informed consent, enrollment, scheduling, and retention strategies.
Ensure informed consent is properly obtained and documented before any study-related procedures.
Monitor source documentation, Electronic Data Capture (EDC) entries, and query resolution to maintain accurate and timely study data.
Ensure adverse events, serious adverse events, and protocol deviations are documented and reported to the PI, Sponsor, and IRB within required timelines.
Oversee investigational product accountability, including receipt, storage, dispensing, temperature monitoring, returns, and destruction.
Supervise specimen collection, processing, storage, and shipment in accordance with laboratory manuals and applicable procedures.
Serve as the primary point of contact for Sponsors, CROs, and clinical monitors, hosting monitoring visits and addressing findings promptly.
- Regulatory and Quality Management
Maintain complete, accurate, and inspection-ready regulatory binders and electronic study files, including FDA Form 1572s, delegation logs, financial disclosures, CVs, licenses, and training records.
Ensure research staff maintain current GCP, human subjects protection, and protocol-specific training.
Verify appropriate delegation of responsibilities by Principal Investigators.
Develop, maintain, and update research Standard Operating Procedures (SOPs), templates, and work instructions.
Coordinate preparation for Sponsor audits and FDA or other regulatory inspections.
Lead the development, implementation, and tracking of Corrective and Preventive Actions (CAPAs).
Ensure applicable clinical studies are registered and maintained on ClinicalTrials.gov as directed.
- Financial and Administrative Management
Monitor study budgets, invoiceable activities, and Sponsor payments, ensuring timely invoicing and financial reconciliation.
Support research billing compliance by distinguishing routine-care charges from research-related expenses in coordination with billing teams.
Prepare enrollment, financial, and operational performance reports for Principal Investigators and clinic leadership.
Manage study supplies, equipment calibration and maintenance records, and vendor relationships.
- Team Leadership and Process Improvement
Recruit, train, schedule, supervise, and evaluate Clinical Research Coordinators and other research personnel.
Allocate workloads across studies and assess team capacity before accepting additional trials.
Promote collaboration between research personnel and clinical teams, including physicians, nurses, medical assistants, front desk staff, and billing professionals.
Identify and recommend improvements to research operations, participant recruitment, and overall efficiency.
Take on additional responsibilities as needed to support the clinic's clinical research program.
Requirements:
The ideal candidate combines substantial clinical research experience with strong regulatory knowledge, operational management capabilities, and proven leadership skills. You should be comfortable managing multiple studies, coordinating diverse stakeholders, and ensuring compliance with complex clinical research requirements. Key qualifications include:
Bachelor's degree in life sciences, nursing, healthcare, or a related field, or an equivalent combination of education and relevant professional experience.
At least 5 years of clinical research experience, including a minimum of 2 years coordinating studies at a clinical research site.
At least 1 year of experience supervising or leading research staff; equivalent informal leadership experience is also considered.
Working knowledge of Good Clinical Practice (GCP), ICH guidelines, FDA regulations (21 CFR Parts 50, 54, 56, and 312/812), and HIPAA requirements.
Experience preparing IRB submissions, managing informed consent processes, and maintaining regulatory documentation.
Strong organizational and project management skills, with the ability to oversee multiple studies, deadlines, and competing priorities.
Excellent written and verbal communication skills, particularly when interacting with Sponsors, clinical monitors, patients, and healthcare professionals.
Proficiency in Microsoft Office and the ability to quickly learn and use EDC, Clinical Trial Management Systems (CTMS), eRegulatory, and Electronic Health Record (EHR) platforms.
Preferred Qualifications:
Current ACRP certification (CCRC or CCRP) or SOCRA certification (CCRP).
Experience with clinical study budgeting, contract reviews, and Sponsor negotiations.
Knowledge of clinical research billing compliance and Medicare coverage analysis.
Experience in relevant therapeutic areas, with rare disease or pediatric clinical research experience considered an advantage.
Clinical skills such as phlebotomy, vital signs measurement, or ECG administration, where permitted by professional licensure and scope of practice.
Previous experience preparing for or participating in FDA inspections and Sponsor audits.
Benefits:
Full-time, 12-month contract-to-hire opportunity.
Fully remote working arrangement within the United States, with no specific home location requirement.
Opportunity to lead and shape a clinical research program across multiple studies.
Exposure to a broad range of clinical research activities, including study start-up, regulatory affairs, financial management, and team leadership.
Collaboration with Principal Investigators, Sponsors, CROs, and multidisciplinary healthcare professionals.
Periodic travel to clinical research sites, particularly in the Midwest, with flexibility required during study start-up.
Opportunity to contribute to impactful clinical research and support the development of new medical treatments.