Associate Clinical Manager, CTC Hub

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

📋 Description

• Supervise the daily management of clinical operations personnel assigned to you.

• Offer coaching, support for professional development, resources, and training.

• Work alongside senior management and executives on strategic planning and business growth.

• Oversee the onboarding and orientation processes for new hires.

• Keep staff CVs, training logs, position descriptions, and experience profiles up to date.

• Assist local resourcing efforts and project/functional leadership activities.

• Address issues that could impact project outcomes.

• Provide training on WPDs, SOPs, local regulations, and clinical operations subjects.

• Recognize training deficiencies and aid in the development of training programs.

• Engage in initiatives aimed at process improvement.

• Facilitate monitoring based on risk assessment.

• Notify management of quality concerns, request QA audits, and assist with audit responses.

• Analyze CTMS, Preclarus, and Clarity systems to assess metrics, KPIs, and project progress.

• Review staff performance and carry out remote or on-site PAVs.

• Manage tasks related to interviewing, selection, job descriptions, development, goal setting, performance evaluation, coaching, counseling, and separations.

• Review and authorize time records, expense claims, leave requests, and overtime.

• Coordinate client CTOS and manage site records.

• Plan, distribute, gather, and ensure the quality of site records via the Site Collaboration tool.

• Organize clinical trial regulatory responsibilities, materials, documentation, submissions, supplies, reporting, and communication with stakeholders.

• Maintain clinical systems and track trial data effectively.

• Support the completion of the TMF and achievement of OMP milestones.

⛳️ Requirements

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

• Prior experience ranging from 0 to 5 years in a related field.

• At least 1 year of leadership experience.

• Secondary education in Business Administration or an equivalent field.

• A minimum of 2 years of experience in responsibilities related to Clinical Trial Operations Specialist.

• 0-1 year of experience in responsibilities associated with Site Records Coordinator.

• Knowledge of the Clinical Operations Landscape.

• Familiarity with the Trial Master File.

• Understanding of the TMF Reference Model.

• Knowledge of Good Clinical Practice standards.

• Proficiency in Good Documentation Practices.

• Experience with Site Collaboration.

• Familiarity with relevant tools and systems.

• Understanding of CTMS.

• Strong communication and stakeholder management skills.

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

🏝️ Benefits

• A global team environment.

• Opportunities for collaboration and professional development.

• A workplace focused on scientific excellence.