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:

Please email your CV along with a Cover Letter to Abdul.ansari@klinera.com

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

• Bachelor’s degree in Life Sciences, Pharmacy, or related field; PhD, advanced degree or certifications (PMP/PRINCE2, ACRP) are a plus.
• Minimum of 8-10 years of experience as a Project Manager delivering Phase I–IV trials in a CRO or sponsor setting.
• Proven track record of leading multi-center, regional or global trials with measurable success on timelines, quality, and budget.
• Advanced skills in trial management, clinical operations, protocol implementation, and stakeholder leadership.
• Line management experience and capability building/mentoring across teams.
• Strong commercial acumen: budget management, change orders, contract/SOW interpretation.
• Excellent communication, negotiation, and conflict resolution skills; adept at working in fast-paced, dynamic environments.
• Experience across multiple therapeutic areas (e.g., Oncology, Hepatology, metabolic, CNS).
• Experience with India and global regulatory/ethics landscapes (CDSCO/NDCTR, ICH-GCP, FDA/EMA/MHRA).
• Depth with operational analytics, enrollment modeling, and risk signal detection tools.