Senior CTM, Internal Medicine

This is a fully remote position, open to applicants in Colombia, +4 more states.

📋 Description

• Oversee all clinical operational and quality elements of assigned studies, which are of low to moderate complexity, ensuring compliance with ICH GCP. Depending on specific project needs, may take on Clinical Study Manager (CSM) responsibilities for smaller or less complex projects.

• Create clinical tools (e.g., Monitoring Plan, Monitoring Guidelines) in collaboration with the Data Quality Plan. Contribute to the development of the Master Action Plan (MAP) for generating clinical-related documents. Guarantee the timely setup, organization, content, and quality of the relevant sections of the Trial Master File (both local and central). May engage in the design and development of CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents as required. Work alongside the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.

• Collaborate with the clinical team and other departments as necessary to fulfill project deliverables. Regularly communicate with the team and lead meetings to ensure that timelines, resources, interactions, and quality are upheld. Responsible for implementing and training standardized clinical monitoring processes within the study according to corporate standard policies. Ensure timely archiving of documents and study materials for the department.

• Ensure the successful completion of the final clinical deliverable within the specified contractual timeframe by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects with tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitor or co-monitor clinical trials to evaluate performance and ensure that contractual obligations are met. In smaller regions, may regularly conduct Accompanied Field Visits (AFVs) and be responsible for project financials.

• May interact with study sites regarding issues such as protocols, patient participation, case report form completion, and other study-related matters.

• May coordinate all start-up activities and ensure that timely ethics committee and regulatory submissions (if applicable) are addressed. Ensure that essential document quality meets the expectations of Regulatory Compliance Review. Review and respond to all questions raised by ethics committees.

• May contribute to the preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities, and identifying additional resource requirements.

⛳️ Requirements

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

• Prior experience that provides the knowledge, skills, and abilities necessary to perform the role (comparable to 5+ years). In certain cases, a combination of appropriate education, training, and/or directly related experience may be considered sufficient for meeting the role's requirements.

• Strong leadership skills, effective in mentoring and training, capable of motivating and integrating teams.

• Excellent planning and organizational abilities to facilitate effective workload prioritization.

• Solid interpersonal and problem-solving capabilities for functioning within a multicultural matrix organization.

• Ability to work effectively in a dynamic environment with complex or ambiguous situations.

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

• Good judgment and decision-making abilities.

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

• Capable of assessing workload against project budget and adjusting resources as necessary.

• Strong financial acumen and knowledge of budgeting, forecasting, and fiscal management.

• High attention to detail.

• Solid understanding of relevant regulations, such as ICH/GCP, FDA guidelines, etc.

• Proficient computer skills for effectively using automated systems and applications such as Outlook, Excel, Word, etc.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and career advancement.

• Comprehensive health benefits including medical, dental, and vision coverage.

• Flexible work environment and potential for remote work options.

• Generous vacation and paid time off policies.

• Supportive team culture and collaborative work environment.