Clinical Team Manager/Sr. (CTM) - Internal Medicine
About The Position
The Senior Clinical Team/Trial Manager is accountable for achieving the final clinical deliverable—usually clean data from evaluable patients as specified in the study protocol—within the contractual timeline. The role interprets complex data and makes sound 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. The therapeutic scope includes Internal Medicine: cardiovascular conditions (stroke, cardiomyopathy, and heart failure), dermatology (alopecia and atopic dermatitis), nephrology, metabolic conditions (diabetes and obesity), and women’s health. The role manages operational and quality aspects of allocated studies in compliance with ICH GCP. It supports study planning and documentation, team coordination, clinical monitoring, site communication, regulatory and start-up activities, forecasting, and clinical resource management. Work is performed in an office environment, with frequent driving to site locations and frequent 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 for prioritizing 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 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, including 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.
- Frequently drive to site locations and travel domestically and internationally.
Nice To Haves
- Transferable experience in healthcare, nursing, medicine, or related disciplines may be considered in combination with clinical trial experience when demonstrating significant clinical expertise, therapeutic-area knowledge, and direct patient-care responsibilities.
- An equivalent combination of appropriate education, training, and directly related experience may be considered sufficient to meet the role requirements.
Responsibilities
- Manage operational and quality aspects of allocated clinical studies of moderate to high complexity in compliance with ICH GCP.
- Depending on project requirements, take on regional Lead CTM or Clinical Study Manager responsibilities, process improvements, complex program management, or broader management and project 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-related documents and ensure timely setup, organization, content, and quality of relevant local and central Trial Master File sections.
- Participate as required in designing and developing 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 clinical and other project departments, communicate regularly with the team, 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.
- Achieve clinical deliverables within contractual timelines by preparing and monitoring clinical activity timelines and metrics, providing status updates, reviewing projects with tracking tools, and implementing recovery actions.
- Review monitoring visit reports and manage CRF collection and query resolution.
- Continuously monitor clinical trial performance and ensure contractual obligations are met; conduct accompanied field visits as applicable and oversee project financials as applicable.
- Communicate with study sites about protocol issues, patient participation, case report form completion, and other study-related matters.
- Coordinate study start-up activities as applicable and ensure essential-document quality meets Regulatory Compliance Review expectations.
- Ensure timely regulatory submissions where appropriate and review and follow up on ethics committee questions.
- Provide input into clinical activity forecast estimates.
- Manage clinical resources, assign and delegate clinical responsibilities, and identify additional resource needs.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
