Principal CTC

🔥 0 minutes ago

🇲🇽 Mexico – Remote

⏰ Full Time

🔴 Lead

✨ Principal

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Provide administrative and technical support to the Project Team as a study lead and cross-functional liaison • Coordinate and facilitate project activities and oversee administration on assigned projects • Act as a buddy during onboarding and train new staff • Identify new training requirements and support departmental and cross-functional process improvement initiatives • Support development of the critical path for site activation and serve as a project-team escalation point • Coordinate, oversee, and complete assigned trial activities according to the task matrix • Perform department, internal, country, and investigator file reviews and document findings • Maintain study documentation, systems, tools, trackers, and eTMF records • Support risk-based monitoring activities and trial administration • Schedule client/internal meetings and complete 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 current clinical trial systems/databases • Coordinate Investigator Site File and Pharmacy binder materials and study supplies • Support translation materials and translation quality control • Liaise locally on submission activity in accordance with global submission strategy • Maintain accurate trial status information and client local affiliate relationships where applicable • Train personnel, functional team members, investigators, and clients as requested • Serve as an alliance-level lead for client integration and eTMF activities • Support site activation, site agreements, budgets, essential documents, site selection, regulatory packages, and site-specific documents • Develop site lists, maintain investigator/site contact details, and complete Site Interest Plans in CTMS • Conduct site surveys, phone interviews, feasibility activities, and follow-up communications • Act as local expert on site capacity and experience and recommend additional sites • Contribute to global feasibility processes, strategic initiatives, and best practices • Collaborate with internal departments, regional teammates, CTLs, CTMs, and trial teams

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Bachelor's degree preferred • At least 6 years of comparable experience, knowledge, skills, and abilities • Equivalent combination of appropriate education, training and/or directly related experience may be considered • Excellent English language and grammar skills and proficient local language skills as needed • Knowledge of applicable country regulations, ICH Good Clinical Practices, organization/client SOPs and WPDs • Proficiency in MS Office (Word, Excel, PowerPoint) • Ability to learn and master clinical trial database systems • Ability to successfully complete the organization's clinical training program • Effective presentation, oral and written communication, negotiation, and problem-solving skills • Basic medical/therapeutic area, medical terminology, and local health systems knowledge • Ability to work in a matrix environment and manage risk appropriately • Occasional driving to site locations and potential occasional travel required

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule

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