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About the Role

The Senior Clinical Trial Manager is accountable for achieving final clinical deliverables within the specified time period, ensuring all clinical activities meet customer expectations for time, quality, and cost, and maintaining profitability through efficient team management. The role involves independent work on moderately to highly complex projects, with potential for regional lead or Clinical Study Manager responsibilities.

Responsibilities

Manage all clinical operational and quality aspects of allocated studies of moderate to high complexity in compliance with ICH GCP.
Develop clinical tools such as Monitoring Plans and Monitoring Guidelines in conjunction with the Data Quality Plan.
Contribute to the development of the Master Action Plan (MAP) for clinical documents.
Ensure timely setup, organization, content, and quality of the Trial Master File.
Collaborate with the project manager to prepare and present at client meetings, including bid defense and hand-off meetings.
Collaborate with the clinical team and other departments to meet project deliverables.
Lead team meetings to ensure timelines, resources, interactions, and quality are maintained.
Implement and train on standardized clinical monitoring processes and corporate standard policies.
Ensure timely archiving of documents and study materials.
Ensure achievement of final clinical deliverable within the contractual time period by preparing and monitoring timelines and metrics.
Provide status updates to the project manager and regularly review projects using tracking and management tools.
Implement recovery actions and review monitoring visit reports.
Manage CRF collection and query resolution.
Continuously monitor clinical trials to assess performance and ensure contractual obligations are met.
Routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
Communicate with study sites regarding protocol, patient participation, case report form completion, and other study-related issues.
Coordinate all start-up activities and ensure essential document quality meets Regulatory Compliance Review expectations.
Ensure timely regulatory submissions are addressed.
Review and follow up on all questions raised by ethics committees.
Provide input into preparation of forecast estimates for clinical activities.
Manage clinical resource assignment, delegation of clinical responsibilities, and identification of additional resource requirements.
May have limited line management responsibilities for Government & Public Health Studies (GPHS) projects in North America.

Requirements

Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
Previous experience comparable to 8+ years that provides the knowledge, skills, and abilities to perform the job.
An equivalency consisting of a combination of appropriate education, training and/or directly related experience will be considered sufficient.

Skills

Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams.
Strong planning and organizational skills.
Strong interpersonal and problem-solving skills.
Solid understanding of change management principles.
Comprehensive understanding of clinical monitoring practices, processes, and requirements.
Strong judgment, decision making, escalation, and risk management skills.
Effective oral and written communication skills, including English language proficiency.
Ability to evaluate own and team members workload against project budget and adjust resources accordingly.
Strong financial acumen and knowledge of budgeting, forecasting, and fiscal management.
Strong attention to detail.
In-depth understanding of relevant regulations (e.g., ICH/GCP, FDA guidelines).
Strong computer skills (Outlook, Excel, Word).
Ability to independently manage clinical-only studies.

Location

Office

Work Type

Standard (Mon-Fri)

Experience Level

8+ years

Education Level

Bachelor's degree or equivalent

About the Company

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence.
You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.