Global Clinical Trial Manager: Lead Delivery & Compliance

ThermoFisher Scientific; Comisión de Fomento de Perú; Híbrido; ARS 122.300.000 - 168.162.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific is seeking a Clinical Trial Manager to lead the operational delivery of clinical studies, ensuring quality, timelines, and budgets are met with a strong focus on patient safety and data integrity.

You will work with sponsors, investigative sites, and cross-functional teams to drive programs from start-up through closeout, assume leadership of the study team, and promote regulatory compliance across global trials.

Formación

• Bachelor’s degree in Life Sciences, Nursing, Healthcare, or a related scientific field.
• Relevant experience in clinical research, clinical operations, study management, or clinical trial leadership within a pharmaceutical, biotechnology, CRO, or healthcare environment.
• Experience aiming for CTM, Sr. CTM, or Clinical Lead opportunities based on experience and leadership capabilities.

Responsabilidades

• Lead clinical operational activities for assigned studies from start-up through study closeout.
• Ensure studies are conducted in compliance with ICH-GCP, regulatory requirements, sponsor expectations, and company procedures.
• Develop and maintain key clinical study documents, including Monitoring Plans, Monitoring Guidelines, and other study-specific tools.
• Contribute to the development and execution of study management plans and clinical deliverables.
• Oversee Trial Master File (TMF) quality, completeness, and inspection readiness.
• Collaborate with project managers, sponsors, CRAs, start-up teams, and cross-functional stakeholders to ensure study objectives are achieved.
• Lead clinical team meetings and provide guidance, oversight, and support to study team members.
• Monitor study timelines, performance metrics, risks, and issue resolution activities.
• Review monitoring reports, study progress, query management, and overall site performance.
• Support study start-up activities, including ethics committee and regulatory submissions, where applicable.
• Manage clinical resources, workload distribution, and identification of additional resource needs.
• Provide project updates and operational insights to internal stakeholders and clients.
• Support financial oversight through resource planning, forecasting, and budget awareness.
• Participate in client meetings, hand-off meetings, bid defense activities, and sponsor-facing interactions as required.
• Drive continuous process improvement initiatives and promote operational excellence across clinical programs.

Conocimientos

Clinical trial operations

Leadership

Project planning

Regulatory compliance

Communication

English proficiency

Educación

Bachelor's degree in Life Sciences

Equivalent combination of education and experience

Herramientas

Microsoft Office

CTMS

Descripción del empleo

Thermo Fisher Scientific is seeking a Clinical Trial Manager to lead the operational delivery of clinical studies, ensuring quality, timelines, and budgets are met with a strong focus on patient safety and data integrity.

You will work with sponsors, investigative sites, and cross-functional teams to drive programs from start-up through closeout, assume leadership of the study team, and promote regulatory compliance across global trials.