Dedicated and reliable project manager with six years experience in the pharmaceutical sector. Skilled in efficiently overseeing intricate clinical trial studies from protocol inception through successful implementation and final database lock.
• Manage 15-20 Phase I and II clinical trial studies from kick-off and Go-Live to maintenance until final database lock is achieved.
• Increasing department success by implementing over 100 change requests into In-Life studies and by completing Go-Lives of at least 4 new builds.
• Develop project plans, facilitate requirements gathering, monitor and ensure timely, high-quality deliverables.
• Handle numerous post Go-Live activities including amendments, system upgrades, and new/updated requirements.
• Single point of contact for Pharma client, addressing project needs and mitigating risks. Work with all onshore and offshore therapeutic areas and shared service roles to promote consistent operations, efficient use of resources and adherence of best practices and SOPs.
• Participate in special projects, continuous learning opportunities and provide mentoring/guidance to new team members as needed.
• Wrote and reviewed, provided instructional feedback on data transfer user requirement specification documents.
• Managed deliverables and communicated with client teams regarding timelines and deliverable status to ensure all milestones were met on time.
• Ensured that the functional requirements met the user's needs and were consistent with the objectives and scope of the project.
• Interacted with internal and external contacts to obtain, clarify, and verify the business needs that would be addressed in the proposed solution.
• Managed project scope and change requests and identified and coordinated joint milestones and deliverables.
• Provided business consultation to Merck cross functional team members and external vendors on all project related issues and decisions.
• Managed ongoing work against project plans, calculated and reported on key project metrics.
Society of Clinical Data Management (SCDM) Conference, San Diego, CA, 10/01/23,
Risk-Based Quality Management and Quality by Design in Clinical Trial Data Management: The Art of Building a Quality Database