Clinical Trial Specialist

19 hours ago

New Delhi, India TRDFIN Support Services Pvt Ltd Full time

Job Overview We are seeking a detail orientedClinical Trial Specialistto 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-endclinical trial operationsfrom 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 withICH-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 inclinical trial operations or clinical research . Strong understanding ofclinical 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 PowerPointCertifications (Nice to Have) ICH-GCP Certification Clinical Research Coordinator (CRC) certification Clinical Trial Management certificationsWhat 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

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