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.

• Create clinical tools and assist in the formulation of the Data Quality Plan and Master Action Plan.

• Guarantee the prompt setup, organization, content, and quality of the Trial Master File sections.

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

• Work in conjunction with project managers to prepare and deliver presentations at client meetings, bid defenses, and hand-off sessions.

• Collaborate with clinical teams and departments to achieve project objectives.

• Facilitate team meetings while managing timelines, resources, interactions, and quality standards.

• Implement and train teams on standardized clinical monitoring methodologies.

• Archive study documents and materials promptly.

• Develop and track clinical timelines and metrics, provide updates on project status, and initiate recovery actions as necessary.

• Evaluate monitoring visit reports, oversee CRF collection and query resolution, and assess clinical trial performance.

• Conduct Accompanied Field Visits and manage project finances as appropriate.

• Liaise with study sites regarding protocols, patient participation, CRF completion, and related matters.

• Coordinate study initiation activities and submissions to ethics committees and regulatory bodies where applicable.

• Ensure the quality of essential documents and address questions from ethics committees.

• Contribute to forecasts of clinical activity and manage clinical resources, responsibilities, delegations, and additional resource requirements.

⛳️ Requirements

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

• Comparable experience of at least 5 years.

• An equivalency consisting of appropriate education, training, and/or directly related experience may be deemed sufficient.

• Prior experience as a CRA is preferred by the team.

• Experience in Alzheimer's and/or Neurology is preferred by the team.

• Strong leadership, mentoring, training, motivation, and team integration abilities.

• Excellent planning and organizational skills.

• Solid interpersonal and problem-solving capabilities.

• Ability to operate effectively in dynamic environments characterized by complexity and ambiguity.

• Familiarity with clinical monitoring practices, processes, and requirements.

• Strong judgment and decision-making abilities.

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

• Capacity to assess workload against project budgets and adjust resources accordingly.

• Financial insight and knowledge in budgeting, forecasting, and fiscal management.

• Exceptional attention to detail.

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

• Proficient computer skills with Outlook, Excel, Word, and related applications.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and development.

• A culture of passion, innovation, and commitment to scientific excellence.