Clinical Team Manager – Internal Medicine

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

📋 Description

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

• Take on roles such as Lead CTM, regional Clinical Study Manager, and responsibilities related to process improvement, program management, and project coordination as required.

• Create clinical tools, Monitoring Plans, Monitoring Guidelines, Data Quality Plans, Master Action Plans, sections of the Trial Master File, CRFs, CRF guidelines, informed consent templates, and documents specific to protocols.

• Work closely with project managers to prepare, organize, and present at client meetings, including bid defense and hand-off sessions.

• Lead meetings for the clinical team and coordinate between teams and departments to uphold timelines, resources, interactions, and quality standards.

• Implement and train teams on standardized clinical monitoring processes.

• Ensure that study documents and materials are archived in a timely manner.

• Prepare and oversee clinical activity timelines and metrics, provide updates on project status, review tracking tools and monitoring visit reports, implement corrective actions, and manage CRF collection and query resolution.

• Monitor clinical trials to evaluate performance and ensure compliance with contractual obligations.

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

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

• Coordinate activities for study start-up and regulatory submissions, and follow up on queries from ethics committees.

• Contribute to clinical activity forecasting.

• Manage clinical resources, including assignment, delegation, and additional resource needs.

⛳️ Requirements

• A bachelor's degree or equivalent, along with relevant formal academic or vocational qualifications.

• A minimum of 5 years of pertinent experience in clinical research, covering areas such as clinical trial operations, study management, clinical monitoring, or similar clinical research functions.

• Transferable experience from healthcare, nursing, medicine, or related fields may be taken into account if combined with clinical trial experience where the candidate demonstrates significant clinical expertise, knowledge in therapeutic areas, and direct patient care responsibilities.

• An equivalent combination of appropriate education, training, and/or directly related experience may also be deemed sufficient.

• Exceptional skills in leadership, mentoring, training, planning, organizational abilities, interpersonal relations, problem-solving, judgment, decision-making, escalation, risk management, financial oversight, attention to detail, and communication.

• Proficiency in the English language.

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

• Knowledge of budgeting, forecasting, and financial management.

• Comprehensive understanding of relevant regulations, including ICH/GCP and FDA guidelines.

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

• Capability to independently manage clinical-only studies.

• Willingness to frequently travel to site locations and undertake domestic and international travel.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• A global team environment.

• Frequent opportunities for domestic and international travel.