Principal CTC

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

📋 Description

• Deliver administrative and technical assistance to project teams as a study lead and cross-functional liaison.

• Organize and facilitate project activities while overseeing administration for assigned clinical trials.

• Evaluate department, internal, country, and investigator files and document observations.

• Ensure that assigned tasks are completed punctually, within budget, and adhere to quality standards.

• Maintain study documentation, team lists, training trackers, system access, activity plans, and eTMF records.

• Assist with risk-based monitoring activities and trial administration.

• Arrange client and internal meetings and prepare meeting minutes.

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

• Send documents to clients and centralized IRB/IEC.

• Analyze and reconcile study metrics and findings reports.

• Maintain vendor trackers and clinical trial systems, including Activate and eTMF.

• Coordinate materials for Investigator Site Files and Pharmacy binders as well as study supplies.

• Assist with translation materials and quality control for translations.

• Collaborate locally to plan and execute submission activities in line with global strategy.

• Train new personnel, other functional team members, investigators, and clients.

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

• Support site activation critical paths, site agreements, budgets, essential documents, and regulatory compliance packages.

• Develop site lists and keep contact details of investigators and site staff up to date.

• Complete Site Interest Plans, manage site communications and follow-ups, and assess survey data.

• Conduct feasibility interviews with physicians and site personnel.

• Address investigator queries and contribute to global feasibility processes and best practices.

• Provide local market insights for identifying and developing new sites.

• Serve as a subject matter expert on feasibility survey tools.

⛳️ Requirements

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

• Bachelor's degree is preferred.

• A minimum of 6 years of relevant experience providing the necessary knowledge, skills, and abilities to perform the role.

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

• Capability to work independently or collaboratively in a team environment.

• Exceptional organizational skills and attention to detail; ability to manage multiple tasks effectively.

• Proficient in analyzing project-specific data and systems.

• Flexibility and adaptability to evolving project timelines.

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

• Excellent command of the English language and grammar, with proficient local language skills as necessary.

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

• Proficient in MS Office (Word, Excel, and PowerPoint) with the ability to master clinical trial database systems.

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

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

• Ability to work in a matrix environment, manage risk, and perform risk escalation.

• Willingness to occasionally drive to site locations and travel as needed.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.