Clinical Team Manager, Internal Medicine

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee the clinical operational and quality components of assigned moderate to high-complexity studies in accordance with ICH GCP.

• Take on roles such as regional Lead CTM, Clinical Study Manager, process improvement, complex program management, management, or project coordination as necessary.

• Create clinical tools like Monitoring Plans and Monitoring Guidelines in alignment with the Data Quality Plan.

• Contribute to the Master Action Plan and guarantee timely setup, organization, content, and quality of sections within the Trial Master File.

• Engage in the development of CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents.

• Work in collaboration with project managers to prepare, organize, and present during client meetings, including bid defenses and hand-off meetings.

• Partner with clinical teams and various departments to achieve project deliverables.

• Lead team meetings while managing timelines, resources, interactions, and quality assurance.

• Implement and provide training on standardized clinical monitoring processes.

• Ensure prompt archiving of documents and study materials.

• Prepare and track clinical activity timelines and metrics, deliver project status reports, utilize tracking and management tools, enact recovery actions, review monitoring visit reports, and handle CRF collection and query resolution.

• Supervise clinical trials, evaluate performance, and guarantee compliance with contractual obligations.

• Conduct Accompanied Field Visits and manage project financials as required.

• Liaise with study sites regarding protocols, patient participation, case report forms, and other study-related matters.

• Coordinate study start-up activities and ensure quality of essential documents meets Regulatory Compliance Review standards.

• Ensure timely submissions to regulatory bodies and address ethics committee inquiries.

• Provide insights into forecasts for clinical activities.

• Manage clinical resources, assign clinical responsibilities, and identify additional resource needs.

⛳️ Requirements

• Bachelor's degree or equivalent formal academic/vocational qualification.

• 5+ years of relevant experience in clinical research, which includes clinical trial operations, study management, clinical monitoring, or similar clinical research activities.

• Transferable experience in healthcare, nursing, medicine, or related fields may be considered when combined with clinical trial experience, provided the candidate demonstrates significant clinical expertise, therapeutic area knowledge, and direct patient care responsibilities.

• An equivalency made up of a combination of suitable education, training, and/or directly related experience may also be deemed adequate.

• Exceptional leadership, mentoring, training, team motivation, planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, risk management, communication, and attention-to-detail skills.

• Strong grasp of change management principles and clinical monitoring practices, processes, and requirements.

• Solid financial acumen and understanding of budgeting, forecasting, and fiscal management.

• Extensive knowledge of pertinent regulations such as ICH/GCP and FDA guidelines.

• Proficient in computer skills, including Outlook, Excel, Word, and other computerized applications.

• Capability to independently manage clinical-only studies.

• Proficiency in the English language.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• Work environment focused on scientific excellence.

• Frequent travel to site locations both domestically and internationally.