Junior CTM (FSP)

ProPharma; United States; On-site; USD 110,000 - 150,000; Full time

Job summary

ProPharma is seeking a Clinical Trial Manager to lead and oversee clinical studies in a collaborative Clinical Operations team.

The role focuses on study-level delivery, partnering with internal stakeholders, and ensuring compliance with ICH-GCP and regulatory standards. The CTM will drive timelines, risk management, and TMF readiness across multiple sites.

Qualifications

• Bachelor's degree in Life Sciences, Nursing or related field.
• 5+ years of clinical research experience in pharma/biotech/CRO.
• Experience as in-house Senior CRA, Associate CTM or CTM.
• Strong knowledge of ICH-GCP and regulatory requirements.
• Experience supporting multicenter trials.
• Excellent organizational and project management skills.
• Strong communication and relationship-building abilities.
• Ability to manage multiple priorities with attention to detail.

Responsibilities

• Manage assigned clinical trials from start-up through closeout.
• Coordinate day-to-day study activities and timelines to meet milestones.
• Serve as operational contact for investigative sites and stakeholders.
• Partner with Clinical Operations, Data Management, Biostatistics, Medical Monitoring, Regulatory Affairs, Clinical Supply, and other teams.
• Lead study team meetings and provide updates on progress, enrollment, risks, and actions.
• Track enrollment, site activation, study metrics, and overall performance.
• Review monitoring visit reports, protocol deviations, and site issues to identify trends.
• Support development and maintenance of study plans, tools, and documents.
• Ensure inspection readiness through oversight of TMF activities.
• Identify operational risks and implement mitigation strategies.
• Contribute to process improvements and best practices in Clinical Operations.

Skills

Clinical Trial Management

ICH-GCP

Regulatory Compliance

Cross-functional Collaboration

Study Start-up & Closeout

Multicenter Trials

Project Management

CTMS

eTMF

EDC

Education

Bachelor's degree in Life Sciences, Nursing, or related field

Tools

CTMS

eTMF

EDC

Job description

We are seeking a Clinical Trial Manager (CTM) to support the execution and oversight of clinical studies within a collaborative Clinical Operations team. The CTM will be responsible for managing day-to-day study activities, partnering with internal stakeholders, supporting investigative sites, and ensuring studies are conducted in compliance with applicable regulations and quality standards.

This position is ideal for an experienced in-house Senior CRA, Lead CRA, or early-career CTM looking to transition into an internal study management role. The successful candidate will work closely with experienced Clinical Trial Managers and Clinical Operations leadership while taking ownership of study-level deliverables and operational execution.

Key Responsibilities

• Manage assigned clinical trials from study start-up through closeout.
• Coordinate day-to-day study activities and timelines to ensure operational milestones are achieved.
• Serve as a key operational contact for investigative sites and study stakeholders.
• Partner with Clinical Operations, Data Management, Biostatistics, Medical Monitoring, Regulatory Affairs, Clinical Supply, and other cross-functional teams to support study execution.
• Lead study team meetings and provide routine updates on study progress, enrollment, risks, and action items.
• Track enrollment, site activation, study metrics, and overall study performance.
• Review monitoring visit reports, protocol deviations, and site issues to identify trends and drive resolutions.
• Support development and maintenance of study plans, study tools, and operational documents.
• Ensure inspection readiness through appropriate oversight of study documentation and Trial Master File activities.
• Identify operational risks and proactively implement mitigation strategies.
• Contribute to process improvements and best practices within Clinical Operations.

Qualifications

Required

• Bachelor's degree in Life Sciences, Nursing, or a related field.
• 5+ years of clinical research experience within a pharmaceutical, biotechnology, or CRO environment.
• Prior experience as an in house Senior CRA, Associate CTM, or Clinical Trial Manager.
• Strong knowledge of clinical trial conduct, ICH-GCP guidelines, and regulatory requirements.
• Experience supporting multicenter clinical trials.
• Excellent organizational and project management skills.
• Strong communication and relationship-building abilities.
• Ability to manage multiple priorities while maintaining attention to detail.

Preferred

• Experience supporting global clinical trials.
• Experience in rare disease, endocrinology, or specialty therapeutic areas.
• Working knowledge of CTMS, eTMF, EDC, and clinical trial technologies.