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CTM / Sr CTM

Thermo Fisher Scientific -
Desde casa

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Detalles del empleo

Tiempo completo

Descripción completa del empleo

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Clinical Trial Manager

Make an Impact at the Forefront of Innovation

At Thermo Fisher Scientific, our Clinical Research team supports leading pharmaceutical, biotechnology, and emerging biopharma companies in advancing innovative therapies worldwide. Having contributed to thousands of clinical trials across more than 100 countries, we are committed to accelerating research that improves patient lives.

As a Clinical Trial Manager (CTM), you will play a critical role in leading the operational delivery of clinical studies, ensuring quality, compliance, and execution excellence. Working closely with sponsors, investigative sites, and cross-functional teams, you will help drive clinical programs from study start-up through closeout while maintaining a strong focus on timelines, patient safety, data integrity, and business objectives.

Position Summary

The Clinical Trial Manager (CTM) is responsible for overseeing the clinical operational and quality aspects of assigned studies, ensuring delivery of clinical milestones and final study deliverables within agreed timelines, budget, and quality expectations. This role provides leadership to cross-functional clinical teams, manages study performance metrics, supports resource planning, and ensures compliance with ICH-GCP, applicable regulations, and company procedures. Depending on project requirements, the CTM may also assume Clinical Study Manager (CSM) or Clinical Lead responsibilities.

Key Responsibilities:

Lead and manage 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 other sponsor-facing interactions as required.
Drive continuous process improvement initiatives and promote operational excellence across clinical programs.

Minimum Qualifications:

Bachelor’s degree in Life Sciences, Nursing, Healthcare, or a related scientific field, or an equivalent combination of education and experience.
Ability to travel as required for business and study-related activities.

Experience:

Relevant experience in clinical research, clinical operations, study management, or clinical trial leadership within a pharmaceutical, biotechnology, CRO, or healthcare environment.
Candidates may be considered for CTM, Sr. CTM, or Clinical Lead opportunities based on their experience, qualifications, leadership capabilities, and demonstrated expertise in clinical trial management.

Preferred Skills & Competencies:

Strong knowledge of clinical trial operations, monitoring processes, and study management principles.
Solid understanding of ICH-GCP guidelines, FDA regulations, and other applicable global regulatory requirements.
Demonstrated leadership, mentoring, and team management skills.
Strong project planning, prioritization, and organizational capabilities.
Excellent problem-solving, critical thinking, and decision-making skills.
Experience managing study timelines, resources, budgets, and performance metrics.
Strong interpersonal and stakeholder management skills in a global matrix environment.
Effective written and verbal communication skills, including English proficiency.
Ability to work successfully in a fast-paced and evolving clinical research environment.
Proficiency with Microsoft Office and clinical trial management systems.
Strong attention to detail and commitment to quality.

Working Conditions and Environment
Work is performed in an office environment with exposure to electrical office equipment.

Frequently drives to site locations and frequently travels both domestic and international.

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Join Us as a Clinical Trial Manager

Make an Impact at the Forefront of Innovation

Position Summary

Key Responsibilities:

Lead and manage 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 other sponsor-facing interactions as required.

Drive continuous process improvement initiatives and promote operational excellence across clinical programs.

Minimum Qualifications:

Bachelor’s degree in Life Sciences, Nursing, Healthcare, or a related scientific field, or an equivalent combination of education and experience.

Ability to travel as required for business and study-related activities.

Experience:

Relevant experience in clinical research, clinical operations, study management, or clinical trial leadership within a pharmaceutical, biotechnology, CRO, or healthcare environment.

Candidates may be considered for CTM, Sr. CTM, or Clinical Lead opportunities based on their experience, qualifications, leadership capabilities, and demonstrated expertise in clinical trial management.

Preferred Skills & Competencies:

Strong knowledge of clinical trial operations, monitoring processes, and study management principles.

Solid understanding of ICH-GCP guidelines, FDA regulations, and other applicable global regulatory requirements.

Demonstrated leadership, mentoring, and team management skills.

Strong project planning, prioritization, and organizational capabilities.

Excellent problem-solving, critical thinking, and decision-making skills.

Experience managing study timelines, resources, budgets, and performance metrics.

Strong interpersonal and stakeholder management skills in a global matrix environment.

Effective written and verbal communication skills, including English proficiency.

Ability to work successfully in a fast-paced and evolving clinical research environment.

Proficiency with Microsoft Office and clinical trial management systems.

Strong attention to detail and commitment to quality.