Maryann Laskowski, Ms Email & Phone Number

Analytical Clinical Trial Operations Lead with 12+ years’ experience planning and executing clinical studies within highly regulated environments. Expert in trial management, study-start-up operations, and regulatory compliance. Skilled at collecting data and coordinating with Regulatory Operations to post trial information on required public forums. Proven success in offering critical, mitigation strategies to CROs, Vendors and Sites to meet milestones and timelines. Obtained Master Degree in Clinical Research Administration (GWU) and have experience working on Global and US, Phase II, III and Post Marketing trials. My operations experience ranges from Site Selection, to creating feasibility questionnaires, recruitment tools, and enrollment flow charts. I have performed cross-functional duties such as participating in Investigative Meetings, Steering Committee meetings, ICF development and Essential Document Review. Over my tenure in pharma, I have given oversight: eCRF review, query resolution, site budgets and payments, monitoring plans, protocol deviation and TMF reconciliation.Strengths include: Performing Risk Assessments, Quality Assurance, Study Metrics Analysis, Post-Marketing Clinical Studies, Vendor Negotiations, Project Management, Good Clinical Practices (GCPs), and Regulatory Compliance.

Listed skills include Clinical Research, Gcp, Ctms, Cro, and 16 others.