Senior Clinical Project Manager

Company Description

Since 2005, KlinEra has partnered with major pharmaceutical, biotech, and device companies, providing innovative and customized clinical trial and research services. The company has successfully completed over 50 large-scale Phase 1, 2, and 3 trials, focusing on clinical trials in India while implementing high-quality protocols and Good Clinical Practices (GCP). KlinEra serves clients in various therapeutic areas including cardiology, infectious diseases, oncology, and more. The organization is diverse with offices located in Mumbai, India, and San Jose, CA, USA.

About the role : As a Senior CPM, you will oversee complex program of Global studies, act as a trusted advisor to sponsors, and mentor CPMs and cross-functional team members. You will own delivery excellence, risk management, and commercial stewardship for assigned projects.

Please email your CV along with a Cover Letter to [HIDDEN TEXT]

Key responsibilities

• Lead end-to-end delivery for complex / late-phase or multi-country trials; oversee multiple concurrent Global studies or an integrated program.
• Serve as senior client liaison, providing strategic delivery guidance, issue resolution, and governance reporting.
• Shape protocol operationalization, country and site strategy, and enrollment rescue plans; lead risk assessment and Quality by Design activities.
• Own project financials : accurate forecasting, margin protection, change order strategy, and variance root-cause analysis.
• Oversee vendor strategy and performance (central labs, Medical imaging, etc.); negotiate scopes with Procurement / BD as needed.
• Ensure inspection readiness at all times; lead audit responses and CAPA programs; partner closely with QA.
• Guide cross-functional leaders (Clinical, DM, Stats, Safety, Medical Writing, Regulatory) to align on critical path and scenario plans.
• Coach / mentor CPMs, CTLs / CRAs; may provide line management for a small team depending on portfolio needs.
• Contribute to proposals, bid defences, and operational strategy in partnership with BD and Solutions teams.

Required qualifications and experience

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Skills Required

clinical operations , change orders, trial management , Protocol Implementation, Budget Management