Clinical Trial Manager

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, ensuring compliance with ICH GCP standards.

• Create clinical tools and assist in the development of Data Quality Plans, Master Action Plans, organization of the Trial Master File, CRFs, informed consent templates, and other protocol-specific documentation.

• Work in partnership with project managers, clinical teams, and various departments to organize and deliver client presentations.

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

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

• Ensure the prompt archiving of study-related documents and materials.

• Meet final clinical deliverables within agreed timelines by overseeing clinical activity timelines and metrics, reviewing tracking tools and monitoring visit reports, executing recovery actions, and managing CRF collection and query resolution.

• Oversee or co-monitor clinical trials and evaluate performance against contractual commitments.

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

• Coordinate study initiation activities along with ethics committee and regulatory submissions.

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

• Contribute to clinical activity forecasts and manage clinical resources, including delegation and additional resource needs.

⛳️ Requirements

• A Bachelor's degree or an equivalent qualification in a relevant field.

• Over 5 years of prior experience demonstrating the necessary knowledge, skills, and abilities for this role.

• Equivalency may be established through a combination of suitable education, training, and/or directly related experience.

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

• Excellent planning and organizational skills for effective workload prioritization.

• Strong interpersonal and problem-solving abilities in a multicultural matrix organization.

• Capacity to work efficiently in dynamic environments with complex and ambiguous scenarios.

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

• Proven judgment and decision-making skills.

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

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

• Financial acumen and understanding of budgeting, forecasting, and fiscal management.

• Exceptional attention to detail.

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

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

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

🏝️ Benefits

• Opportunity to work within a global team environment.

• Access to collaboration and professional development opportunities.

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