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Senior Clinical Project Manager
Amaris is an independent and international Consulting Group specialized in Management and Technologies.
Amaris operates in over 45 countries delivering services in Business & Management Consulting, IT/Information Systems, Telecommunications & Networking, Engineering, Pharmaceutical & Biotechnology.
Since 2007, the company has grown exponentially and is committed to building lasting relationships with its clients, delivering innovative solutions from project inception to execution.
-Lead the Clinical Trial Team and assigned resources to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures.
- Accountable for all operational aspects of assigned clinical studies (interventional and non-interventional studies) executed by PLS Post Launch Scientific Support
- Lead Clinical Trial Teams responsible for full trial execution from protocol generation to clinical trial report/manuscript writing.
-Accountable for ongoing and effective collaboration with Sponsor, PLS Line Functions (medical writing, statistics, data management, monitoring, etc.), CPOs.
Advanced degree or equivalent education/degree in life science/healthcare is required.
-10+ years’ Clinical Operations experience with at least 7 years managerial experience in planning, executing, reporting and publishing clinical studies (interventional and non-interventional) in a pharmaceutical company or contract research organization.
- Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process.
- Good leadership, negotiation and project management skills, trial management.