Principal Clinical Trial Coordinator

🔥 16 minutes ago

🇧🇬 Bulgaria – Remote

⏰ Full Time

🔴 Lead

✨ Clinical Trial Coordinator

👻 Ghost score 12%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Provide administrative and technical support to project teams as a study lead and cross-functional liaison • Coordinate, facilitate, and oversee assigned clinical trial project activities • Perform department, internal, country, and investigator file reviews and document findings • Ensure allocated tasks are completed on time, within budget, and to quality standards • Maintain study documentation, project trackers, team lists, training requirements, system access, and activity plans • Keep the electronic Trial Master File current and support risk-based monitoring activities • Process documents, distribute communications, provide reports, and organize client/internal meetings and 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; resolve site documentation findings • Maintain vendor trackers and coordinate Investigator Site File, pharmacy binder, and study supply materials • Support translation materials and translation quality control • Provide system support for Activate and eTMF and maintain current databases • Liaise locally on submission activity in accordance with global submission strategy • Train new personnel and other functional team members, investigators, and clients as requested • Serve as an alliance-level lead for client integration and eTMF activities • Support site activation targets, including site agreements, budgets, essential documents, regulatory packages, and site-specific documents • Develop site lists, maintain investigator/site contact details, and complete Site Interest Plans in CTMS • Conduct site contact, follow-up, surveys, phone interviews, and feasibility activities • Coordinate with Global Investigator Services and contribute to global feasibility processes and best practices • Recommend new sites using local market knowledge and serve as a subject matter expert on feasibility survey tools

🎯 Requirements

• 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 • A combination of appropriate education, training and/or directly related experience may be considered sufficient • Excellent English language and grammar skills and proficient local language skills as needed • Proficiency in MS Office (Word, Excel, and PowerPoint) • Ability to learn and master clinical trial database systems • Ability to successfully complete the organization's clinical training program • Knowledge of applicable country regulations, ICH Good Clinical Practices, organization/client SOPs and WPDs • Effective presentation, oral and written communication, negotiation, and problem-solving skills • Basic medical/therapeutic area and medical terminology knowledge • Basic knowledge of local health systems • Ability to work in a matrix environment and manage risk appropriately • Occasional drives to site locations; potential occasional travel required

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule • Professional training and onboarding support • Training opportunities and knowledge development • Potential occasional travel to site locations

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