Senior Non-Interventional Studies Clinical Team Manager

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

📋 Description

• Oversee the clinical operational and quality dimensions of moderate- to high-complexity studies while ensuring compliance with ICH GCP.

• Take on roles such as Lead CTM, Clinical Study Manager, or responsibilities in process improvement, program management, management, or project coordination as needed.

• Create clinical tools, monitoring strategies, guidelines, data quality plans, and comprehensive action plans.

• Guarantee the timely setup, organization, content quality, and archiving of Trial Master File documents and study materials.

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

• Collaborate with project managers to organize and deliver client meetings, including bid defenses and hand-off sessions.

• Lead clinical team meetings and coordinate with various departments to uphold timelines, resource management, interactions, and quality standards.

• Implement and train teams on standardized clinical monitoring methodologies.

• Track clinical activity timelines, metrics, project statuses, recovery actions, monitoring visit reports, CRF collection, query resolutions, trial performance, and adherence to contractual obligations.

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

• Organize study start-up tasks, regulatory submissions, and ethics committee follow-ups when necessary.

• Contribute insights into clinical activity forecasts.

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

• Conduct supervised field visits and oversee project financials when required.

• For assigned North American GPHS projects, assume limited line management responsibilities as applicable.

⛳️ Requirements

• Bachelor's degree or an equivalent qualification with relevant formal academic or vocational training.

• A minimum of 8 years of prior experience, or an equivalent mix of education, training, and directly related experience.

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

• Strong grasp of change management principles.

• Thorough understanding of clinical monitoring practices, processes, and regulatory requirements.

• Excellent oral and written communication skills, with proficiency in the English language.

• Financial literacy and expertise in budgeting, forecasting, and fiscal oversight.

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

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

• Ability to independently manage clinical-only studies.

• Capability to work within a multicultural matrix organization.

• Competence in assessing workload against project budgets and adjusting resources as necessary.

🏝️ Benefits

• Global team environment.

• Opportunities for collaboration and professional development.

• A culture driven by passion, innovation, and a commitment to scientific excellence.