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

Overview

The Clinical Team Manager (CTM) is accountable for delivering the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the contractual time period, while maintaining profitability through efficient management of the clinical team.

What you'll do

• Manage all clinical operational and quality aspects of allocated studies of moderate to high complexity, in compliance with ICH GCP.
• May assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities, or take on additional responsibilities such as process improvements, managing complex programs, or wider management or 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 clinical related documents.
• Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central).
• May participate 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.
• Regularly communicate with the team and lead team meetings to ensure timelines, resources, interactions and quality are maintained.
• Implement and train on 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, review projects using tracking tools, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution.
• Continuously monitor clinical trials to assess performance and ensure contractual obligations are met.
• May routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
• Communicate with study sites on protocol, patient participation, case report form completion and other study-related issues.
• May coordinate start-up activities and ensure essential document quality meets Regulatory Compliance Review expectations.
• Ensure timely regulatory submissions (if appropriate) and review and follow up on all questions raised by ethics committees.
• Provide input into forecast estimates for clinical activities.
• Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.

What you'll need

• 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.
• 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 team members' workload.
• 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 adjusting 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 computerized applications such as Outlook, Excel, Word.
• Capable of independently managing clinical-only studies.

Nice to have

• Preferred therapeutic experience: Dermatology (Alopecia Areata and/or Atopic Dermatitis preferred), 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.

Details

• Desired location: West or Central region, preferably.
• Work schedule: Standard (Mon-Fri).
• Work is performed in an office environment with exposure to electrical office equipment.
• Frequently drives to site locations and frequently travels both domestic and international.