Job Overview
We are seeking a detail oriented Clinical Trial Specialist to support the planning, execution, and management of clinical trials in compliance with regulatory and ethical standards. The role involves coordinating trial activities, maintaining documentation, and ensuring smooth collaboration among internal teams, investigators, and external partners.
Key Responsibilities
- Support end-to-end clinical trial operations from study start up to close-out.
- Coordinate with investigators, CROs, and study sites to ensure protocol adherence.
- Prepare, maintain, and manage essential trial documentation and study files.
- Assist with site initiation, monitoring, and close-out activities.
- Track study timelines, milestones, and deliverables.
- Ensure compliance with ICH-GCP, SOPs, and regulatory requirements.
- Support IRB/EC submissions, amendments, and approvals.
- Manage safety reporting, deviations, and issue tracking.
- Assist in audit and inspection readiness.
- Support data collection, query resolution, and database lock activities.
Required Skills & Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or a related field.
- 2+ years of experience in clinical trial operations or clinical research.
- Strong understanding of clinical trial processes and ICH-GCP guidelines.
- Experience working with CROs, investigators, and clinical sites.
- Strong documentation, organizational, and communication skills.
- Ability to manage multiple studies and priorities effectively.
- Attention to detail and strong compliance mindset.
Tools & Systems (Preferred)
- Clinical Trial Management Systems (CTMS)
- Electronic Trial Master File (eTMF) systems
- Electronic Data Capture (EDC) systems
- Microsoft Excel, Word, and PowerPoint
Certifications (Nice to Have)
- ICH-GCP Certification
- Clinical Research Coordinator (CRC) certification
- Clinical Trial Management certifications
What We Offer
- Competitive compensation and benefits
- Exposure to global clinical trials and regulatory environments
- Opportunities for career growth in clinical research and operations
- Collaborative and compliance-focused work culture
