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

Desired location: West or Central region.

About the role

The Clinical Team Manager (CTM) 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 role involves working to ensure that all clinical deliverables meet the customer's time, quality, and cost expectations, and maintaining profitability by ensuring clinical activity is conducted within contract scope through efficient management of the clinical team. The therapeutic scope includes Internal Medicine—Dermatology, GI (UC/CD), Cardiovascular, Liver, Nephrology, Immunology, Rare Disease, Diabetes, Obesity, Dyslipidemia, Women's Health, Rheumatology (RA, SLE, Gout), Cell & Gene Therapy, and CAR-T in Autoimmune.

Responsibilities

• Manage all clinical operational and quality aspects of allocated studies of moderate to high complexity in compliance with ICH GCP.
• Assume Lead CTM responsibilities on a regional level, Clinical Study Manager (CSM) responsibilities, or take on additional responsibilities such as process improvements, managing complex programs, or wider project coordination.
• 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 to meet project deliverables.
• Regularly communicate with the team and lead team meetings to ensure timelines, resources, interactions, and quality are maintained.
• Implement and train standardized clinical monitoring processes within the study 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 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 clinical trials to assess performance and ensure contractual obligations are met.
• Conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
• 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 expectations.
• Ensure timely regulatory submissions (if appropriate) and follow up on questions raised by 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 therapeutic experience: Dermatology, GI (UC/CD), Cardiovascular, Liver, Nephrology, Immunology, Rare Disease, Diabetes, Obesity, Dyslipidemia, Women's Health, Rheumatology (RA, SLE, Gout), Cell & Gene Therapy, and CAR-T in Autoimmune.

Skills

• Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams.
• Strong planning and organizational skills to enable effective prioritization of workload and workload of team members.
• Strong interpersonal and problem-solving skills to enable working in a multicultural matrix organization.
• Solid understanding of change management principles.
• Comprehensive understanding of the practices, processes, and requirements of clinical monitoring.
• Strong judgment, decision-making, escalation, and risk management skills.
• Effective oral and written communication skills, including English language proficiency.
• Capable of evaluating 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).
• Strong computer skills to effectively use automated systems and applications such as Outlook, Excel, Word, etc.
• Capable of independently managing clinical-only studies.

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.