Global Clinical Trial Manager - Ops & Compliance Lead

ThermoFisher Scientific; Colombia; Remote; COP 120,000,000 - 180,000,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Clinical Trial Manager to lead the operational delivery of clinical studies, ensuring quality, timelines, data integrity, and safety while working with sponsors, investigative sites, and cross-functional teams.

The CTM will oversee study start-up through closeout, manage TMF quality, contribute to study management plans, and mentor study teams, with opportunities to advance to CSM or Clinical Lead based on performance.

Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Healthcare, or related field.
• Ability to travel as required for business and study-related activities.
• Experience in clinical research, operations, study management, or clinical trial leadership within pharma, biotech, CRO, or healthcare environments.

Responsibilities

• Lead clinical operational activities for assigned studies from start-up through study closeout.
• Ensure studies comply with ICH-GCP, regulatory requirements, sponsor expectations, and company procedures.
• Develop and maintain key study documents and tools (Monitoring Plans, Guidelines, etc.).
• Contribute to study management plans and clinical deliverables.
• Oversee TMF quality, completeness, and inspection readiness.
• Collaborate with project managers, sponsors, CRAs, and cross-functional teams to meet objectives.
• Lead clinical team meetings and provide guidance to study teams.
• Monitor timelines, performance metrics, risks, and issue resolution.
• Review monitoring reports, study progress, and site performance.
• Support start-up activities including ethics committee and regulatory submissions where applicable.
• Manage clinical resources and budgeting considerations.
• Provide updates to internal stakeholders and clients, and support financial oversight.

Skills

Clinical trial operations

ICH-GCP knowledge

FDA regulations

Leadership

Project planning

Stakeholder management

Communication skills

Microsoft Office & CTMS

Attention to detail

Problem solving

Education

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

Tools

CTMS

MS Office

Job description

Thermo Fisher Scientific is seeking a Clinical Trial Manager to lead the operational delivery of clinical studies, ensuring quality, timelines, data integrity, and safety while working with sponsors, investigative sites, and cross-functional teams.

The CTM will oversee study start-up through closeout, manage TMF quality, contribute to study management plans, and mentor study teams, with opportunities to advance to CSM or Clinical Lead based on performance.