Job Summary

GENOVA CLINICAL RESEARCH is seeking a Qualified Project Lead with demonstrated hands-on experience managing Global studies from Phase I-IV. The role will lead cross-functional team, ensuring timely and compliant deliverables in alignment with project requirements.

Key Responsibilities

• Manage end-to-end execution of phase I-IV Global clinical trials
• Develop and maintain detailed project plans, timelines, and submission trackers
• Manage regulatory affairs, QA, medical writing, and external vendors
• Serve as the primary interface between GENOVA and Client
• Monitor Project activities, identify risks, and proactively implement mitigation plans
• Manage scope changes and ensure alignment with contractual and regulatory commitments
• Prepare and present regular project status reports to internal and external stakeholders
• Ensure submission milestones are met in compliance with FDA, EMA, JFDA and ICH guidelines and any other regulatory body

Qualifications & Experience

• Bachelor’s degree in pharmacy, Life Sciences, Medicine, or related discipline.
• Minimum 4–6 years of experience in clinical project management and regulatory
• Strong experience in managing phase I-IV clinical studies
• Strong experience in preparing project budget, Project management plan, Gantt Charts and risk management plan.
• Proven experience managing FDA and EMA submissions
• Strong understanding of ICH guidelines, FDA and EMA regulatory frameworks
• Experience working with CROs, and health authorities
• PMP certification is a strong advantage
• Excellent communication, leadership, and stakeholder management skills
• Excellent written and verbal communication skills in English

Apply now or send your CV to: [email protected]
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