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Sr Clinical Trial Coordinator / Clinical Trial Coordinator Ii

4+ years
Not Disclosed
10 Oct. 8, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Sr. Clinical Trial Coordinator / Clinical Trial Coordinator II

Location: Remote, India
Job ID: R-01329124
Job Type: Full-time
Category: Clinical Research
Work Arrangement: Fully Remote


About the Role

As a Sr. Clinical Trial Coordinator / Clinical Trial Coordinator II, you will provide essential administrative and technical support to project teams conducting global clinical trials. You’ll coordinate trial activities, maintain study documentation, ensure compliance with timelines and quality standards, and act as a liaison between cross-functional teams. This role is ideal for candidates with experience in eTMF, Veeva Vault, CTMS tools, and global clinical trial coordination.

You will also play a key role in process improvements, onboarding new staff, and supporting project managers in ensuring seamless execution of study deliverables.


Work Schedule

  • Shift: Second Shift (Afternoons)

Work Environment

  • Setting: Office / Remote


Key Responsibilities

Project & Study Coordination

  • Coordinate, oversee, and complete assigned trial activities as outlined in the study task matrix.

  • Serve as a cross-functional liaison for project teams and may act as a study lead.

  • Ensure tasks are completed on time, within budget, and in line with quality standards.

  • Proactively communicate risks to project leads and line managers.

Documentation & Systems Management

  • Maintain and review study documentation in accordance with (e)TMF file review schedules.

  • Support GoBalto, eTMF, Veeva Vault, and CTMS systems.

  • Track project-specific training requirements, system access management, and activity plans.

  • Ensure all study files (departmental, internal, country, and investigator) are up-to-date and audit-ready.

Administrative Support

  • Perform administrative tasks such as document processing, mass mailings, and communication with internal and external stakeholders.

  • Schedule and organize client/internal meetings, including preparation of meeting minutes.

  • Support Risk-Based Monitoring (RBM) activities and ISF/Pharmacy binder distribution.

  • Manage and track local regulatory documents and transmit required documentation to clients and IRB/IEC.

  • Assist with translation materials and translation QC when required.

  • Maintain and reconcile study metrics, reports, and vendor trackers.

Cross-functional Collaboration

  • Act as a buddy/trainer for new team members during onboarding.

  • Support departmental process improvement initiatives.

  • May attend Kick-off Meetings (KOMs) and provide meeting support (notes, tracking, action items).


Qualifications

Education:

  • Bachelor’s degree preferred (Life Sciences or related field).

Experience:

  • Minimum 4+ years experience as a Clinical Trial Coordinator.

  • Hands-on experience with:

    • Veeva Vault

    • CTMS tools

    • eTMF systems

  • Experience supporting global clinical trials and project managers.


Skills & Competencies

  • Strong organizational skills and attention to detail.

  • Proven ability to handle multiple tasks and reprioritize effectively.

  • Analytical mindset with ability to assess project-specific data and systems.

  • Strong customer focus and proactive problem-solving.

  • Solid knowledge of:

    • ICH-GCP guidelines

    • Country-specific regulations

    • SOPs/WPDs for clinical operations.

  • Excellent English communication (written & verbal) and presentation skills.

  • Proficient in MS Office Suite (Word, Excel, PowerPoint) and clinical trial database systems.

  • Ability to work independently or as part of a team.

  • Self-motivated, positive attitude with strong interpersonal skills.

  • Capable of completing PPD clinical training programs successfully.


Why Join Us

Be part of a global CRO at the forefront of clinical innovation. You’ll collaborate with diverse teams to bring life-changing therapies to patients worldwide while developing your expertise in clinical operations, documentation systems, and project coordination.