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About the Role

The Senior Clinical Team (Trial) Manager is accountable for achieving final clinical deliverables within the contractual time period, ensuring quality and profitability through efficient team management. This role involves independent work on complex projects and may include 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, organize, and present at client meetings.
• Collaborate with the clinical team and other departments to meet project deliverables.
• Communicate regularly with the team and lead team meetings to ensure timelines, resources, interactions, and quality are maintained.
• Implement and train standardized clinical monitoring processes.
• Ensure timely archiving of documents and study materials.
• Ensure achievement of final clinical deliverables 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, review monitoring visit reports, and manage CRF collection and query resolution.
• Continuously monitor clinical trials to assess performance and ensure contractual obligations are met.
• 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 and follow up on questions raised by ethics committees.
• Provide input into preparation of forecast estimates for clinical activities.
• Manage clinical resources, including assignment, delegation of responsibilities, and identification of additional resource requirements.

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
• In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
• Preferred experience: experience in STM role and/or previous experience in non-interventional / Phase IV studies / RWE studies.

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, etc.
• Strong computer skills (Outlook, Excel, Word).
• Capable of independently managing 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.