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Tier-1 pharma brand, mid-level (3–5 yrs) role, and metro Hyderabad increase candidate competition.
Clinical trial operations skills are industry-specific to pharma/CROs, limiting cross-industry transferability.
Explicit 3–5 years, mandatory clinical trial/regulatory experience and CTMS (Veeva) preference tighten screening.
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Manage and execute centralized clinical trial start-up, maintenance, and close-out documentation activities for global trials, ensuring regulatory compliance and ethical standards.
Serve as main contact for essential document management and submission processes across clinical sites, IRB/IECs, CROs, vendors, and internal study teams.
Support outsourcing activities and ensure adherence to global/local study procedures, including site activation, quality control, and regulatory submissions.
Bachelor's degree in legal, life sciences, business administration, or equivalent; advanced degree is a plus.
3-5 years of clinical development and operational experience in pharmaceutical, biotech, CRO, or similar fields.
Hands-on experience with clinical trial documentation, regulatory submissions (IRB/IECs, agencies), and clinical study start-up/activation documentation.
Knowledge of ICH/GCP, drug development processes, and experience with clinical trial systems such as CTMS (Veeva Vault preferred).
Experienced in managing cross-functional and multicultural teams within a matrix organizational structure.
Skilled at stakeholder management and effective communication to support trial execution and compliance.
Capable of handling complex, ambiguous environments with strong organizational and time-management skills to meet multiple priorities.