Company Overview: Thermo Fisher Scientific is a global leader in scientific services, supporting a healthier, cleaner, and safer world. With revenues of $13 billion, the company operates in pharmaceutical and biotech, clinical diagnostics, and environmental sectors through brands like Thermo Scientific and Fisher Scientific.
Position: Clinical Trial Coordinator (CTC) II – Functional Service Partnership
Role Summary: The Clinical Trial Coordinator is an integral part of the Global Study Team, contributing to study delivery, time, cost, and quality management. This role involves managing trial documentation, vendor oversight, project tracking, and risk management to ensure the study meets regulatory standards.
Key Responsibilities:
- Collaborate with Study Manager or Study Delivery Lead to support operational study activities from setup to archival.
- Maintain and monitor internal systems, databases, and project plans for study tracking.
- Manage and maintain study-related documents, including Protocol, Informed Consent Forms, and other study plans.
- Act as a key contact for vendor management and oversee CRO activities, ensuring timely delivery of outsourced services.
- Track recruitment, compliance, budget, and protocol deviations at the country level.
- Facilitate study team meetings, document actions, and manage study communications.
- Oversee delivery of clinical supplies and manage potential risks to continuity of supply.
- Ensure eTMF completeness through regular document review and verification.
- Oversee budget, task orders, and expense tracking to ensure alignment with agreements.
Candidate Profile:
- Education: Bachelor’s degree in Life Sciences or related field.
- Experience: At least 1+ years in a pharmaceutical or scientific environment, with foundational knowledge of clinical trials, GCP, and ICH guidelines.
- Skills:
- Strong project management skills with an understanding of financial tracking.
- Familiarity with Trial Master File systems and clinical trial processes.
- Excellent communication, relationship-building skills, and attention to detail.
- Proficiency in MS Office; advanced Excel and clinical trial management systems knowledge is an asset.
- Problem-solving, analytical thinking, and the ability to manage multiple priorities effectively.
Location: Remote, India
Application Deadline: 30th November 2024
Industry: Clinical Research