Remote Trial Master File Jobs (NOW HIRING)

Clinical Trial Manager (CTM)

Location: Remote (U.S.)
Pay Rate: $64.23/hour

Position Summary

We are seeking an experienced Clinical Trial Manager (CTM) to oversee the operational execution of clinical studies from start-up through closeout. This fully remote role is responsible for ensuring clinical trials are delivered on time, within budget, and in compliance with ICH-GCP, FDA regulations, and study protocols. The ideal candidate will have prior clinical trial management experience, neurology clinical trial experience, and a strong background in clinical monitoring, study management, and cross-functional leadership.

Key Responsibilities

• Manage all operational and quality aspects of assigned clinical studies from study start-up through closeout.

• Ensure studies are conducted in compliance with ICH-GCP, FDA regulations, company SOPs, and study protocols.

• Develop and maintain clinical study tools, including Monitoring Plans, Monitoring Guidelines, and Data Quality Plans.

• Collaborate with cross-functional teams, sponsors, CRO partners, and study sites to achieve project milestones and deliverables.

• Lead clinical team meetings and provide ongoing communication regarding study timelines, risks, and project status.

• Monitor study progress through performance metrics, tracking tools, and monitoring reports to ensure contractual obligations are met.

• Review monitoring visit reports, trip reports, query resolution, and case report form (CRF) completion for quality and timeliness.

• Identify study risks, trends, and site performance issues and implement corrective actions or escalation plans as appropriate.

• Support Trial Master File (TMF) management by ensuring accurate, complete, and inspection-ready documentation.

• Coordinate study start-up activities, including ethics committee submissions, regulatory documentation, and essential document review.

• Assist with clinical resource planning, workload forecasting, and project budget management.

• Participate in sponsor meetings, bid defense presentations, and project handoff meetings as needed.

• May conduct accompanied field visits and provide mentoring and oversight to Clinical Research Associates (CRAs) or Site Managers.

Required Qualifications

• Bachelor's degree or equivalent combination of education and relevant experience.

• Minimum 5 years of clinical trial management, study management, or clinical monitoring experience.

• Experience managing neurology clinical trials is required.

• Strong understanding of clinical trial operations, monitoring, and study oversight.

• Knowledge of ICH-GCP, FDA regulations, and applicable global regulatory requirements.

Preferred Qualifications

• Experience managing rare disease clinical trials.

• Experience managing global or multi-site clinical trials.

• CRO or pharmaceutical industry experience.

• Experience with Trial Master File (TMF) management and inspection readiness.

• Familiarity with clinical trial management systems (CTMS), EDC systems, and electronic Trial Master Files (eTMF).

Knowledge, Skills & Abilities

• Strong leadership and team management skills.

• Excellent project planning, organization, and prioritization abilities.

• Experience leading cross-functional clinical teams.

• Strong analytical, problem-solving, and decision-making skills.

• Excellent verbal and written communication skills.

• Ability to manage multiple studies and competing priorities in a fast-paced environment.

• Financial awareness, including project budgeting and resource planning.

• Proficiency with Microsoft Office, including Excel, Word, Outlook, and PowerPoint.

• Ability to work independently in a fully remote environment while maintaining strong collaboration across teams.

Work Environment

• Fully Remote (U.S.)

• Monday–Friday schedule.

• Flexibility to work East Coast or West Coast business hours is required.

• Occasional travel may be required based on study needs.

• Potential opportunity for full-time conversion based on performance and business needs.

Pay Details: $64.23 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
Military connected talent encouraged to apply
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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: 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.