Principal CTC

• Provide administrative and technical support to project teams as a study lead and cross-functional liaison
• Coordinate and facilitate project activities and oversee administration on assigned projects
• Act as an onboarding buddy and train new personnel on processes and systems
• Identify training requirements and support process improvement and change management initiatives
• Develop critical paths for site activation and serve as an escalation point for project teams
• Coordinate, oversee, and complete assigned trial activities according to task matrices
• Perform department, internal, country, investigator file, and eTMF reviews
• Track task completion, risks, budgets, quality standards, training requirements, system access, activity plans, and trial status
• Support risk-based monitoring activities and study administration
• Schedule client and internal meetings and prepare meeting minutes
• Review and track local regulatory documents and support audit readiness and audit responses
• Transmit documents to clients and centralized IRB/IEC
• Analyze and reconcile study metrics and findings reports
• Maintain vendor trackers and clinical trial systems, including Activate, eTMF, CTMS, and related databases
• Coordinate Investigator Site File and Pharmacy binder materials, study supplies, and translation materials
• Liaise locally to align submission activity with global project strategies
• Develop client local affiliate relationships where applicable
• Support site feasibility, site selection, site contact, survey completion, and site follow-up activities
• Conduct scripted or unscripted phone interviews with physicians and site personnel
• Resolve investigator queries and maintain investigator account and contact information
• Contribute to global feasibility processes, strategic initiatives, and best practices
• Support negotiation and finalization of site agreements, budgets, and essential documents
• Prepare regulatory compliance review packages and country/site-specific documents
• Coordinate internal departments to align site start-up activities with activation critical paths
• Develop and maintain site lists and investigator/site staff contact details
• Serve as a subject matter expert on feasibility survey tools
• Ensure clinical trial execution excellence, regulatory task delivery, stakeholder coordination, documentation, reporting, and operational continuity at study level

• High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification
• Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to at least 6 years
• Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered
• Bachelor's degree preferred
• Ability to work independently or in a team
• Excellent organizational skills and attention to detail
• Ability to analyze project-specific data and systems
• Flexibility and adaptability to changing project timelines
• Knowledge of applicable country regulations, ICH Good Clinical Practices, organization/client SOPs and WPDs
• Excellent English language and grammar skills and proficient local language skills as needed
• Effective presentation, oral, and written communication skills
• Proficiency in Microsoft Word, Excel, PowerPoint, and clinical trial database systems
• Ability to successfully complete the organization’s clinical training program
• Problem-solving, negotiation, risk management, and escalation skills
• Basic medical/therapeutic area and medical terminology knowledge
• Basic knowledge of local health systems
• Ability to work in a matrix environment
• Occasional driving to site locations and potential occasional travel
• Secondary education in Business Administration or equivalent for the client CTOS role

• Fully remote work mode
• Standard Monday–Friday work schedule
• Potential occasional travel
• Clinical training program
• Opportunity to work with global pharmaceutical and biotechnology clients
• Professional training and development through onboarding, process training, and best-practice collaboration