CTM - FSP - Germany

thermofisher; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Clinical Operations Leader to manage trials of low to moderate complexity, ensuring timelines, quality, and budgets. The role coordinates a clinical team, maintains study documentation, and may take on study management duties for smaller projects.

Travel is frequent, domestically and internationally, and the office-based setup requires strong leadership, attention to detail, and the ability to mentor multicultural teams.

Qualifications

• Bachelor’s degree or equivalent qualification.
• 5+ years of relevant clinical monitoring or trial management experience.
• Strong knowledge of ICH-GCP and regulatory guidance.
• Leadership, planning, organization, and communication skills.
• Budgeting and forecasting with resource alignment.
• Proficiency with common office applications.

Responsibilities

• Oversee trial conduct in line with ICH-GCP and project requirements.
• Create or contribute to monitoring plans and TMF sections.
• Coordinate team communications, align resources and timelines.
• Track milestones, review monitoring visit reports, support CRF collection.
• Coordinate site communications and regulatory submissions when assigned.
• Support project and client meetings with forecasting and resource management.

Skills

Clinical monitoring

Leadership

Budgeting

Project coordination

Regulatory knowledge

Education

Bachelor’s degree

Tools

MS Office

Job description

Role overview

Manage the clinical operations and quality of assigned trials, generally of low to moderate complexity, and deliver study work to agreed timelines, quality standards, and budgets. The role coordinates a clinical team, maintains study documentation, and may take on study management duties for smaller or less complex projects.

Responsibilities

• Oversee trial conduct in line with ICH-GCP and project requirements; monitor progress and take recovery action when needed.
• Create or contribute to monitoring plans and other clinical tools, and maintain accurate local and central Trial Master File sections.
• Coordinate team communications and meetings, align resources and timelines, and train staff on study monitoring processes.
• Track clinical milestones and metrics, review monitoring visit reports, and support case report form collection and query resolution.
• Coordinate site communications and, where assigned, study start-up, ethics committee interactions, and regulatory submissions.
• Contribute to forecasts, manage clinical resource assignments, and support project and client meetings.

Requirements

• Bachelor’s degree or equivalent relevant academic or vocational qualification.
• Experience comparable to five or more years in relevant work; an equivalent combination of education, training, and directly related experience may be considered.
• Strong understanding of clinical monitoring practices and applicable requirements, including ICH-GCP and relevant regulatory guidance.
• Leadership, planning, organization, and communication skills, including the ability to mentor and coordinate multicultural teams.
• Sound judgment, attention to detail, and ability to manage changing or ambiguous situations.
• Budgeting and forecasting knowledge, with the ability to align workload and resources to project budgets; effective use of common office applications.

Benefits and work setup

The role is described as office-based and involves frequent travel to study sites, both within the country and internationally.