FSP Prin Clinical Trial Coordinator

**Work Schedule** Standard (Mon-Fri)

**Environmental Conditions** Office

Join Us as a Principal Clinical Trial Coordinator -- Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100 countries in the last 5 years.

* Ability to work in a matrix environment
* A proven relationship builder
* An independent thinker
* Ability to manage risk and perform risk escalation appropriately

**Principle Clinical Trial Coordinator** **Role Summary:** Responsible for coordinating and supporting end-to-end clinical trial activities, ensuring operational excellence, regulatory compliance, and timely study execution. Works closely with CTLs, CTMs, investigators, vendors, and cross-functional teams to manage trial documentation, systems, reporting, and stakeholder communication.

**Key Responsibilities**

* Coordinate and track study activities, timelines, and deliverables.
* Maintain and review eTMF/TMF, CTMS, study trackers, and trial documentation.
* Support regulatory submissions, audit readiness, and compliance with ICH-GCP and SOPs.
* Schedule meetings, prepare meeting minutes, and facilitate communication across study teams.
* Manage study supplies, investigator files, vendor trackers, and trial systems.
* Compile and analyze study metrics, reports, and operational data.
* Support site activation, feasibility, and document collection activities as required.

**Required Skills**

* Clinical Trial Operations
* CTMS \& eTMF/TMF Management
* Regulatory Documentation \& ICH-GCP
* Meeting Coordination \& Minutes of Meetings
* Veeva Vault (preferred)
* Study Tracking \& Reporting
* Microsoft Office Suite
* Strong communication and stakeholder management skills

**Education \& Experience**

* Bachelor's degree preferred (Life Sciences, Pharmacy, Clinical Research, or related field).
* Relevant experience in Clinical Trial Coordination, Clinical Operations, or Clinical Research.
* Experience with CTMS, eTMF/Veeva Vault, and study documentation management preferred
* 6 years of experience working in clinical trial coordinator role.
* Hands on experience in managing end to end eTMF activities (Setup filing, Maintaining, Finalising)
* Hands on work experience in coordinating with global project managers, onsite monitors, sites.
* Hands on work experience in writing plans for study by coordinating with internal and external stakeholders.