Job Title: Sr. Clinical Trial Coordinator / Clinical Trial Coordinator II
Location: Remote, India
Job ID: R-01329124
Job Type: Full-time
Category: Clinical Research
Work Schedule: Second Shift (Afternoons)
Work Environment: Office / Fully Remote
About the Company
At Thermo Fisher Scientific, our clinical research services team plays a vital role in bringing life-changing therapies to market. Through our PPD® clinical research portfolio, we combine deep scientific and clinical expertise to advance drug development and address the world’s most critical health challenges.
As part of a leading global contract research organization (CRO), we deliver excellence, innovation, and speed in every stage of the clinical trial process.
Role Overview
The Sr. Clinical Trial Coordinator / Clinical Trial Coordinator II provides administrative, technical, and coordination support to clinical project teams.
This role involves overseeing project activities, supporting process improvements, maintaining study documentation, and serving as a cross-functional liaison within the study team. The coordinator may also act as a study lead or mentor (buddy) for new team members.
Key Responsibilities
Project Coordination & Support
Coordinate, oversee, and complete assigned trial activities as per the project task matrix.
Provide administrative and technical support to project teams and study leads.
Serve as a study lead or point of contact for cross-functional communication and issue resolution.
Act as a buddy during onboarding and assist in training new staff.
Support departmental and cross-functional initiatives for continuous process improvements.
Documentation & Compliance
Conduct department, internal, country, and investigator file reviews, documenting findings appropriately.
Maintain study-specific documentation, including (e)TMF, trackers, and system logs.
Ensure all documentation meets audit-readiness standards and is updated according to review schedules.
Manage system access, study team lists, and project-specific training records.
Provide system support for platforms like GoBalto, eTMF, and Veeva Vault.
Operational Support
Assist in Risk-Based Monitoring (RBM) activities.
Process and transmit regulatory documents to clients and IRB/IEC.
Schedule and organize internal and client meetings, including note-taking and distribution of meeting minutes.
Manage vendor trackers, ISF/Pharmacy binders, and non-clinical study supplies.
Support translation material preparation and QC when required.
Participate in study kick-off meetings and provide operational support throughout the project.
Analysis & Reporting
Analyze and reconcile study metrics and findings reports.
Assist in resolving site documentation issues and clarification requests.
Track and report on project-level activities to ensure deadlines and quality standards are met.
Qualifications
Education
Bachelor’s degree preferred in Life Sciences, Pharmacy, or related field.
Experience
Minimum 4 years of experience as a Clinical Trial Coordinator.
Hands-on experience with:
Veeva Vault and CTMS tools
eTMF systems
Global clinical trials and supporting international Project Managers
Skills & Competencies
Strong organizational and multitasking abilities with high attention to detail.
Proven ability to analyze project data for accuracy, consistency, and efficiency.
Deep understanding of ICH-GCP guidelines, country regulations, and client SOPs/WPDs.
Excellent communication, presentation, and interpersonal skills.
Fluent in English (written and spoken); proficiency in local language as needed.
Proficient in Microsoft Office (Word, Excel, PowerPoint) and quick to master clinical databases.
Strong customer focus, professionalism, and teamwork spirit.
Demonstrated flexibility and adaptability to shifting priorities and tight timelines.
Self-motivated with a positive attitude and commitment to quality.
Ability to successfully complete PPD Clinical Training Program.
Why Join Thermo Fisher Scientific
Work with a global leader driving breakthroughs in clinical research.
Be part of an innovative and mission-driven team that transforms patient outcomes.
Opportunities for career growth, learning, and leadership development.
Supportive and inclusive remote work culture with global exposure.
Equal Opportunity Employer
Thermo Fisher Scientific is an EEO/Affirmative Action Employer. We value diversity and inclusion and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other legally protected category.
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