Clinical Team Manager/Sr. (CTM) - Internal Medicine

Thermo Fisher Scientific•Wilmington, NC

6d•Onsite

About The Position

The Senior Clinical Team/Trial Manager is accountable for delivering the final clinical study deliverable—usually clean data from evaluable patients as specified in the study protocol—within the customer contract timeframe. The role interprets complex data and makes business decisions with line-management support, ensuring clinical deliverables meet customer expectations for time, quality, and cost while maintaining profitability through efficient clinical-team management. The Senior Clinical Trial Manager typically works independently on projects of moderate to high complexity and may take on regional lead or Clinical Study Manager responsibilities. Therapeutic areas include Internal Medicine: Cardiovascular (stroke, cardiomyopathy, and heart failure), Dermatology (alopecia and atopic dermatitis), Nephrology, Metabolic (diabetes and obesity), and Women's Health. The role manages the clinical operational and quality aspects of allocated studies in compliance with ICH GCP. It may include regional lead CTM or Clinical Study Manager duties, process improvements, complex program management, and wider management or project coordination responsibilities. The manager develops clinical tools and contributes to study plans and documents, supports client meetings, coordinates with the clinical team and other departments, and oversees monitoring processes, study documentation, timelines, metrics, resources, and deliverables. The position may also involve study start-up, regulatory and ethics committee follow-up, financial oversight, and frequent travel to study sites, domestically and internationally. The position requires a bachelor's degree or equivalent relevant qualification and at least five years of relevant clinical research experience. Transferable healthcare, nursing, or medical experience may be considered alongside clinical trial experience when accompanied by significant clinical expertise, therapeutic-area knowledge, and direct patient-care responsibilities. The work is performed in an office environment, with frequent driving to site locations and domestic and international travel.

Requirements

Bachelor's degree or equivalent and a relevant formal academic or vocational qualification.
At least 5 years of relevant clinical research experience, including clinical trial operations, study management, clinical monitoring, or related clinical research activities.
Strong leadership skills, including mentoring, training, motivating, and integrating teams.
Strong planning and organizational skills to prioritize personal and team workloads.
Strong interpersonal and problem-solving skills for working in a multicultural matrix organization.
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 personal and team workloads against project budgets 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, such as ICH/GCP and FDA guidelines.
Strong computer skills, including use of Outlook, Excel, Word, and other automated systems and computerized applications.
Ability to independently manage clinical-only studies.
Ability to drive to site locations and travel domestically and internationally frequently.

Nice To Haves

Transferable experience in healthcare, nursing, medicine, or related disciplines may be considered in combination with clinical trial experience when the candidate demonstrates significant clinical expertise, therapeutic-area knowledge, and direct patient-care responsibilities.
A combination of appropriate education, training, and/or directly related experience may be considered equivalent to the stated requirements in some cases.

Responsibilities

Manage clinical operational and quality aspects of allocated studies of moderate to high complexity in compliance with ICH GCP.
As project-specific needs require, take on regional Lead CTM or Clinical Study Manager responsibilities, process improvements, complex program management, or broader management and coordination duties.
Develop clinical tools, such as monitoring plans and monitoring guidelines, in conjunction with the Data Quality Plan.
Contribute to the Master Action Plan for clinical documents and ensure timely setup, organization, content, and quality of relevant local and central Trial Master File sections.
Participate as required 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.
Coordinate 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 in accordance with study requirements and corporate policies.
Ensure timely archiving of departmental documents and study materials.
Deliver clinical outputs within contractual timelines by preparing and monitoring clinical activity timelines and metrics, updating the project manager, reviewing project tracking tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution.
Continuously monitor trial performance to ensure contractual obligations are met; conduct accompanied field visits as applicable and oversee project financials as applicable.
Communicate with study sites about protocol, patient participation, case report form completion, and other study-related issues.
As applicable, coordinate study start-up activities, ensure essential document quality meets Regulatory Compliance Review expectations, address timely regulatory submissions, and review and follow up on ethics committee questions.
Provide input to clinical activity forecast estimates.
Manage clinical resources, assign and delegate clinical responsibilities, and identify additional resource requirements.