Principal CTC

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

📋 Description

• Provide both administrative and technical assistance to the Project Team in the role of study lead and as a cross-functional liaison.

• Coordinate and facilitate various project activities while overseeing administration for assigned projects.

• Serve as a buddy during the onboarding process and provide training to new staff members.

• Identify new training needs and contribute to departmental and cross-functional process improvement initiatives.

• Assist in the development of the critical path for site activation and act as a point of escalation for the project team.

• Coordinate, supervise, and execute assigned trial activities as per the task matrix.

• Conduct reviews of department, internal, country, and investigator files, documenting findings appropriately.

• Maintain study documentation, systems, tools, trackers, and eTMF records efficiently.

• Support risk-based monitoring activities and manage trial administration tasks.

• Schedule internal and client meetings, ensuring accurate meeting minutes are recorded.

• Review and monitor local regulatory documents, supporting audit readiness and audit responses.

• Transmit necessary documents to clients and centralized IRB/IEC.

• Analyze and reconcile study metrics along with findings reports.

• Maintain vendor trackers and keep clinical trial systems/databases up to date.

• Coordinate the Investigator Site File and Pharmacy binder materials, as well as study supplies.

• Support the translation of materials and oversee translation quality control.

• Liaise locally regarding submission activities in line with the global submission strategy.

• Maintain accurate trial status information and manage client relationships with local affiliates as needed.

• Train personnel, functional team members, investigators, and clients upon request.

• Act as the alliance-level lead for client integration and eTMF activities.

• Assist with site activation, site agreements, budgets, essential documents, site selection, regulatory packages, and site-specific documentation.

• Develop site lists, keep investigator/site contact details current, and complete Site Interest Plans in CTMS.

• Conduct site surveys, phone interviews, feasibility activities, and follow-up communications.

• Function as a local expert on site capacity and experience, recommending additional sites as necessary.

• Contribute to global feasibility processes, strategic initiatives, and the establishment of best practices.

• Collaborate with internal departments, regional teammates, CTLs, CTMs, and trial teams effectively.

⛳️ Requirements

• High/Secondary school diploma or equivalent along with relevant formal academic/vocational qualifications.

• Bachelor's degree is preferred.

• A minimum of 6 years of relevant experience, knowledge, skills, and abilities is required.

• A combination of appropriate education, training, and/or directly related experience may also be considered.

• Excellent proficiency in English language and grammar, along with proficient local language skills as necessary.

• Familiarity with applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs.

• Proficiency in MS Office applications (Word, Excel, PowerPoint).

• Capability to learn and master clinical trial database systems effectively.

• Ability to successfully complete the organization's clinical training program.

• Strong presentation, oral and written communication, negotiation, and problem-solving skills.

• Basic understanding of medical/therapeutic areas, medical terminology, and local health systems.

• Ability to work effectively in a matrix environment and manage risks appropriately.

• Occasional driving to site locations and potential travel may be required.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.