Clinical Team Manager / Sr. (CTM) – HemOnc

About the role

The Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time, quality, and cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. The position involves working on projects of low to moderate complexity and as part of a team of CTMs.

Responsibilities

• Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP.
• Assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects, in accordance to project specific requirements.
• Develop clinical tools (e.g., Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan.
• Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents.
• Ensure timely set up, organization, content, and quality of the relevant sections of the Trial Master File (local and central).
• Participate in the design and development of CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents as required.
• Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
• Collaborate with the clinical team and other departments as needed to meet deliverables of the project.
• Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained.
• Implement and train standardized clinical monitoring processes within the study and according to corporate standard policies.
• Ensure timely archiving of documents and study materials for the department.
• Prepare and monitor clinical activity 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 to ensure achievement of the final clinical deliverable within the contractual time period.
• Continuously monitor or co-monitor clinical trials to assess performance and ensure contractual obligations are met.
• Conduct Accompanied Field Visits (AFVs) in smaller regions and be accountable for project financials.
• Communicate with study sites regarding issues such as protocol, patient participation, case report form completion, and other study-related issues.
• Coordinate all start-up activities and ensure timely ethics committee and regulatory submissions (if appropriate).
• Ensure that essential document quality meets the expectation of Regulatory Compliance Review.
• Review and follow up on all questions raised by the ethics committees.
• Provide input into preparation of forecast estimates for clinical activities.
• Responsible for clinical resource management, assignment, delegation of clinical responsibilities, and identification of additional resource requirements.

Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
• 5+ years of relevant experience in clinical research, including clinical trial operations, study management, clinical monitoring, or related clinical research activities.
• Transferable experience in healthcare, nursing, medicine, or related disciplines may be considered in combination with clinical trial experience where the candidate demonstrates significant clinical expertise, therapeutic area knowledge, and direct patient care responsibilities.

Preferred Qualifications

• FSO/CRO experience.
• Global CTM experience managing global teams.
• Indication experience: Ovarian, Sickle Cell, Non-Hodgkins Lymphoma, Multiple Myeloma, Glioma, Head and Neck, Pancreas, Prostate, Non-Small Cell Lung, Breast, Colorectal, Radiopharmaceutical, Cell and Gene Therapy, and/or CART-T.

Skills

• Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams.
• Good planning and organizational skills to enable effective prioritization of workload.
• Solid interpersonal and problem-solving skills to enable working in a multicultural matrix organization.
• Capable of working effectively in a changing environment with complex/ambiguous situations.
• Familiarity with the practices, processes, and requirements of clinical monitoring.
• Good judgment and decision-making skills.
• Effective oral and written communication skills, including English language proficiency.
• Capable of evaluating workload against project budget and adjusting resources accordingly.
• Sound financial acumen and knowledge of budgeting, forecasting, and fiscal management.
• Strong attention to detail.
• Solid understanding of relevant regulations e.g., ICH/GCP, FDA guidelines, etc.
• Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.

Schedule

Standard (Mon-Fri)

Environmental Conditions

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequent driving to site locations and frequent domestic and international travel.

Benefits

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.