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Tier-1 pharma, mid-level clinical ops role in Hyderabad increases applicant competition.
Clinical trial and regulatory experience is highly specific to pharma/biotech/CRO environments.
Mandatory 3+ years clinical development and regulatory/CTMS experience make screening highly selective.
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Manage and execute centralized activities for global clinical trials focusing on clinical documentation collection, review, and approval.
Act as main point of contact for essential document management, ethical/regulatory submission activities, and country/site activation for clinical trials.
Support outsourcing activities including vendor interfacing, contracting, and compliance with regulatory and company policies.
Bachelor's degree in legal, life science, business administration, or equivalent; advanced degree is a plus.
Minimum 3 years of relevant clinical development and operational experience in pharmaceutical, biotech, CRO, or similar fields.
Experience in global site monitoring (Clinical Research Associate) report review preferred; prior therapeutic area expertise preferred but not mandatory.
Hands-on experience with regulatory documentation submission to IRB/IECs and Regulatory Agencies; knowledge of ICH/GCP and drug development process.
Experienced in managing complex clinical trial documentation and coordination across multiple stakeholders in global settings.
Proficient with clinical trial management systems, preferably CTMS and Veeva Vault, and other clinical trial enabling technologies.
Capable of managing multiple priorities and cross-functional teams within matrix organizations with strong organizational and communication skills.