Clinical Team Manager / Sr. (CTM) - Neuro

Thermo Fisher Scientific•Wilmington, NC

3d•Onsite

About The Position

The Clinical Trial Manager (CTM) is accountable for achieving the final clinical deliverable—usually clean data from evaluable patients, as specified in the study protocol—within the period specified in the customer contract. The CTM interprets project issues and makes business decisions with support from experienced team members or a line manager. The role ensures clinical deliverables meet customer expectations for time, quality, and cost while maintaining profitability by conducting clinical activities within contract scope and efficiently managing the clinical team. The position focuses on low- to moderate-complexity projects and may be part of a team of CTMs. The CTM manages clinical operational and quality aspects of allocated studies in compliance with ICH GCP and may assume Clinical Study Manager responsibilities on small or less complex projects. The role develops clinical tools and contributes to study plans and documents, coordinates and communicates with project teams and other departments, monitors study progress and deliverables, supports site and start-up activities, and manages clinical resources. The work is performed in an office environment and involves frequent domestic and international travel, including driving to site locations.

Requirements

Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
At least 5 years of relevant experience in clinical research, including clinical trial operations, study management, clinical monitoring, or related clinical research activities.
Experience in end-to-end study management.
Good leadership skills, including mentoring, training, motivating, and integrating teams.
Planning and organizational skills to prioritize workload effectively.
Interpersonal and problem-solving skills for working in a multicultural matrix organization.
Ability to work effectively in changing environments and complex or ambiguous situations.
Familiarity with clinical monitoring practices, processes, and requirements.
Good judgment and decision-making skills.
Effective oral and written communication skills, including English proficiency.
Ability to evaluate workload against project budgets and adjust resources accordingly.
Financial acumen and knowledge of budgeting, forecasting, and fiscal management.
Strong attention to detail.
Understanding of relevant regulations, including ICH/GCP and FDA guidelines.
Computer skills for using automated systems and applications such as Outlook, Excel, and Word.

Nice To Haves

Early Phase and study start-up experience.
Experience in psychiatry, particularly depression or schizophrenia.
Experience in Parkinson's disease, sleep disorders, epilepsy, or hearing loss.
Experience in rare diseases, including Charcot-Marie-Tooth disease, myasthenia gravis, Huntington's disease, ALS, Duchenne muscular dystrophy, chronic inflammatory demyelinating polyneuropathy, myotonic dystrophy type 1, or facioscapulohumeral muscular dystrophy.
CAR-T experience.

Responsibilities

Manage clinical operational and quality aspects of allocated low- to moderate-complexity studies in compliance with ICH GCP; may assume Clinical Study Manager responsibilities on small or less complex projects.
Develop clinical tools such as Monitoring Plans and Monitoring Guidelines in conjunction with the Data Quality Plan, and contribute to the Master Action Plan for clinical-related documents.
Ensure timely set-up, organization, content, and quality of relevant local and central Trial Master File sections.
Participate as needed in the design and development of CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents.
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 to meet project deliverables; communicate regularly and lead team meetings to maintain timelines, resources, interactions, and quality.
Implement and train teams on standardized clinical monitoring processes according to study requirements and corporate policies.
Ensure timely archiving of departmental documents and study materials.
Achieve final clinical deliverables within contractual timelines by preparing and monitoring clinical activity timelines and metrics, providing status updates, reviewing projects with tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution.
Continuously monitor or co-monitor clinical trials to assess performance and ensure contractual obligations are met.
In smaller regions, routinely conduct Accompanied Field Visits and be accountable for project financials, as applicable.
Communicate with study sites about protocol, patient participation, case report form completion, and other study-related issues, as needed.
Coordinate study start-up activities and ensure timely ethics committee and regulatory submissions, where appropriate.
Ensure essential document quality meets Regulatory Compliance Review expectations and review and follow up on questions from ethics committees.
Provide input into clinical activity forecast estimates, as needed.
Manage clinical resources, assign and delegate clinical responsibilities, and identify additional resource requirements.