Fully Remote WFH Job For BPharma, Apply For Clinical Trial Coordinator at Thermo Fisher Scientific
FSP Clinical Trial Coordinator II
Location: Remote, India
Job Id: R-01287251
Job Type: Full-Time
Category: Clinical Research
Remote: Fully Remote
Work Schedule
- Standard (Mon-Fri)
Environmental Conditions
- Office
Job Description
CTC – Functional Service Partnership Job Purpose:
- Clinical Trial Coordinator – Project Specialist is a key member of the Global Study Team, contributing to delivering the clinical study to time, cost, and quality, and ensuring inspection readiness by overseeing study eTMF completeness.
- The CTC role was implemented to broaden impact on the business by driving continuous improvement initiatives, sharing best practices across the business, and focusing on increasing operational delivery efficiency.
A Day in the Life:
- Works closely with the Study Manager or Study Delivery Lead on end-to-end operational study delivery activities, from study setup to study archival, focusing on setting up, maintaining, and ensuring the completeness of internal systems/databases/tracking tools and project plans (CSAP).
- Collaborates cross-functionally with internal and external partners on clinical study management activities, as agreed with the Study Delivery Lead, for in-house and outsourced studies across all phases and therapeutic areas, in accordance with STOM, current clinical study regulations, and GSK procedures.
- Monitors study conduct and progress, identifying, resolving, and escalating risks/issues that may impact the study’s delivery to quality, timeline, and budget objectives.
- Reviews key clinical documents, including the Protocol and Informed Consent Forms, and leads the development of study plans (e.g., Monitoring Plan, Vendor Management Plan, Protocol Deviation Management Plan, Risk Management Plan, Communication Plan).
- Facilitates interactions and meetings with internal (e.g., regulatory, LOC, quality assurance, Monitors meeting) and external partners (e.g., CROs, third-party vendors) to ensure successful study delivery.
- Manages vendor relationships and CRO oversight, acting as a primary contact and ensuring the timely delivery of study-specific activities.
- Oversees country-specific aspects of studies, including recruitment progress, data completeness, compliance, local budgets, protocol deviations, and regulatory approvals.
- Coordinates study-related activities and manages study team communication, including scheduling meetings, creating info-spaces, newsletters, action logs, and team lists.
- Ensures the delivery of clinical supplies, investigational products, and all study materials, communicating issues/risks and proposing solutions as necessary.
- Maintains data oversight to ensure the study is inspection-ready, including oversight of eTMF completeness and verification of eTMF document quality.
- Manages budget oversight, including Task/Change Orders, expenses, tracking updates, and escalating issues to the SDL.
- Actively contributes to squads as per STOM requirements.
Education Requirements:
- Graduate/Bachelor’s degree in life sciences or a related field.
Experience:
- Graduate or Bachelor’s degree with 1+ years of relevant work experience in a pharmaceutical/scientific environment.
- Scientific background and knowledge of clinical trials (including ICH-GCP) and the drug development process is an asset.
- Foundational knowledge of the clinical study delivery process, including regulations, operational best practices, and industry standards.
- Familiarity with key systems used in clinical trial delivery, including the Trial Master File industry-standard.
- Strong project management skills, preferably with analytical/financial skills.
- Excellent verbal and written communication in English.
- Strong communication and relationship-building skills.
Other Job-Related Skills:
- Good knowledge and skills in applying applicable clinical trial regulatory requirements (GCP, ICH guidelines).
- Ability to manage multiple priorities across various clinical studies with strong planning, time management, and prioritization skills.
- Independent critical thinking, problem-solving skills, and ability to take a risk-based approach.
- Logical and analytical thinking with attention to detail, effective training skills, and a quality mindset.
- Basic project finance and accounting knowledge to understand budgets, invoices, cross-charges, and expense reports.
- Proficiency in Microsoft Office tools (Excel, PowerPoint, Word, Outlook); knowledge of advanced Excel, timelines/budget tracking systems, and clinical trial management systems is an asset.
- Excellent stakeholder management, communication skills, and interpersonal skills.
- Results-driven, efficient, motivated, and dynamic personality; adaptable to evolving, challenging environments.
- Ability to work cross-functionally in squads within the agile model.
- Role model aligned with GSK core values and expectations; team spirit with an understanding of cultural differences.
What We Offer:
- Opportunity to contribute to life-changing therapies.
- Comprehensive training and development programs.
- Collaborative and inclusive work environment.
- Attractive compensation and comprehensive perks.
Working Conditions and Environment:
- Work performed in office, laboratory, clinical, and/or home office settings, with exposure to electrical office equipment.
- Occasional site drives and potential occasional travel required.
Note: This position is remote.
Apply for the position here
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