Clinical Trial Manager

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

📋 Description

• Oversee the clinical operational and quality components of assigned low- to moderate-complexity studies, ensuring adherence to ICH GCP standards.

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

• Create clinical tools, Monitoring Plans, Monitoring Guidelines, and assist in developing Data Quality Plans and Master Action Plans.

• Ensure the timely establishment, organization, content, and quality of pertinent sections of the Trial Master File.

• Engage in the design of CRFs, CRF guidelines, informed consent templates, and documents specific to protocols.

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

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

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

• Implement and train teams on standardized clinical monitoring procedures.

• Timely archive documents and study materials.

• Prepare and track clinical activity timelines and metrics.

• Provide updates on project status, utilize tracking tools for project reviews, and execute recovery actions as needed.

• Evaluate monitoring visit reports, manage the collection of CRFs, and resolve queries.

• Monitor or co-monitor clinical trials to evaluate performance and ensure adherence to contractual obligations.

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

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

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

• Ensure the quality of essential documents and follow up on queries from ethics committees.

• Contribute to clinical activity forecasts.

• Manage clinical resources, delegate tasks, and identify additional staffing needs.

⛳️ Requirements

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

• A minimum of 5 years of comparable experience.

• Consideration may be given to a combination of relevant education, training, and/or related experience.

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

• Strong planning and organizational abilities.

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

• Capability to work effectively in dynamic environments with complex or ambiguous situations.

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

• Sound judgment and decision-making capabilities.

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

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

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

• Strong attention to detail.

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

• Proficient in computer applications such as Outlook, Excel, Word, and similar software.

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

🏝️ Benefits

• A global team environment.

• Opportunities for collaboration and professional development.

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

• Standard work schedule from Monday to Friday.