Clinical Team Manager – FSP

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

📋 Description

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

• Take on the role of Clinical Study Manager for smaller or less complex projects as necessary.

• Create clinical tools, monitoring plans, and guidelines, while contributing to the Master Action Plan.

• Establish, organize, maintain, and archive relevant sections of the Trial Master File and study materials.

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

• Work alongside project managers to prepare and deliver presentations for client meetings, including bid defense and hand-off sessions.

• Collaborate with clinical and cross-functional teams, leading team meetings effectively.

• Implement and provide training on standardized clinical monitoring processes to teams.

• Prepare and track clinical activity timelines and metrics, deliver project status updates, and execute recovery actions as needed.

• Review monitoring visit reports and manage the collection of CRFs and resolution of queries.

• Monitor or co-monitor clinical trials to evaluate performance and ensure contractual commitments are met.

• Conduct Accompanied Field Visits and manage project finances in smaller regions when necessary.

• Communicate with study sites regarding protocol adherence, patient participation, CRF completion, and related matters.

• Coordinate study start-up activities and handle ethics committee and regulatory submissions when required.

• Review and respond to inquiries from the ethics committee.

• Offer input on clinical activity forecasts and manage clinical resources, delegation, and additional resource needs.

⛳️ Requirements

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

• Over 5 years of relevant experience in a comparable role.

• Consideration may be given to a combination of appropriate education, training, and/or directly related experience for equivalency.

• Skills in leadership, mentoring, training, motivation, and team integration.

• Strong planning and organizational abilities.

• Interpersonal and problem-solving skills within a multicultural matrix organization.

• Capacity to work effectively in dynamic environments involving complex or ambiguous situations.

• Knowledge of clinical monitoring practices, processes, and regulatory requirements.

• Strong judgment and decision-making capabilities.

• Proficient oral and written communication skills, including fluency in English.

• Ability to assess workload against project budgets and make necessary resource adjustments.

• Financial acumen with knowledge of budgeting, forecasting, and fiscal management.

• Exceptional attention to detail.

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

• Proficient in computer skills using Outlook, Excel, Word, and similar automated systems.

• Willingness to travel frequently both domestically and internationally, including driving to site locations.

🏝️ Benefits

• A globally collaborative team environment.

• Opportunities for collaboration and professional development.

• A workplace focused on scientific excellence.