Senior, Clinical Trial Manager, CTM - FSP (North America, EAST COAST)

Thermo Fisher Scientific Inc.; Bethesda (MD); Remote; USD 90,000 - 130,000; Full time

Job summary

A leading company in life sciences is seeking a Senior Clinical Trial Manager. This role focuses on coordinating and overseeing clinical monitoring activities for Phase 3 studies, ensuring compliance with regulations and maintaining quality and budget adherence. Ideal candidates will have a solid background in clinical research along with strong organizational skills and a degree in life sciences.

Qualifications

• Minimum 3 years as a Field CRA, with experience in Oncology and/or Neuroscience.
• At least 1-2 years as Lead CRA.
• Knowledge of GCP and ICH, ability to travel 20-25%.

Responsibilities

• Oversee study start-up and ensure clinical activities coordination.
• Conduct co-monitoring visits and verify data.
• Contribute to SOP updates and training.

Skills

Proficiency in MS Office

Organizational skills

Financial acumen

Excellent communication skills

Education

Life sciences or medical degree

CRA certification

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Summary

Take responsibility for coordinating clinical monitoring activities, overseeing CRO clinical/site management activities, and co-monitoring assigned international Phase 3 clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP), and SOPs to ensure quality, timely delivery, and budget adherence. Assist in delivering Clinical Development objectives and achieving clinical excellence. Coordinate the achievement of study deliverables within a matrix organization under the leadership of Clinical Project Managers (CPM). Act as a client representative at sites and build relationships with investigators.

Role: Senior CTM, Clinical Trial Manager, FSP Dedicated

Location: US, Remote — candidate MUST be located on the East Coast; CST location is also considered but East Coast is highly preferred.

Main Responsibilities/Job Expectations

1. Ensure clinical activities coordination & oversight
   • Oversee study start-up, working with CROs and relevant team members (DM, reg, CMC, etc.); review feasibility reports; support site selection; verify collection of essential documents; ensure activities are completed prior to site initiation as per oversight plan.
   • Support and ensure completion of Client/CRO EDC system tasks; train CRAs; organize monitor and investigator meetings; evaluate timelines and establish milestones to ensure quality and timeliness.
   • Prepare and oversee documents such as monitoring oversight plans; customize site KPIs; validate final clinical study documents; review site visit reports; support and guide Internal CRAs; coordinate CRO relationships; participate in RFP and BID processes; liaise with Medical Science Liaisons.
   • Contribute to the operation of the TA Group and cross-departmental initiatives.
2. Ensure monitoring oversight activities
   • Conduct co-monitoring visits, verify data, report in CTMS, ensure data collection timelines, coordinate sample flow, review TMF, prepare for audits, and act as a site CRA or backup as needed.
3. Additional activities
   • Contribute to SOP updates, training, and cross-departmental initiatives.
   • Follow EHS regulations, report risks, participate in EHS training.

Knowledge, Abilities, and Experience

• Education: Life sciences or medical degree; CRA certification required.
• Experience: Minimum 3 years as a Field CRA; experience in Oncology and/or Neuroscience; at least 1-2 years as Lead CRA; experience with global, multi-site studies; knowledge of GCP, ICH, and clinical documentation; ability to travel 20-25%; proficiency in English.

Key Technical Competencies

• Strong understanding of regulated environments, proficiency in MS Office, organizational skills, financial acumen, knowledge of R&D, and excellent communication skills.
• Proactive, flexible, team-oriented, with a pragmatic approach and integrity.

All activities must comply with client SOPs and documentation standards.