Cynthia Sandy

Project Management Consultant @Harmony Biosciences

Naples, FL, US
EMAILS
c•••••@harmonybiosciences.com
MOBILE NUMBERS
+13•••••••62

Signup · Get unlimited contacts

WORK HISTORY

Nov 2024 — Present

Project Management Consultant @Harmony Biosciences

View department →

EDUCATION

1992 — 1995

University of St. Francis

Master of Science (M.S.), Health Services Administration

1978 — 1982

The University of Akron

Bachelor of Science (B.S.), Nursing

SKILLS

PsychiatryProject ManagementGood Clinical Practice (Gcp)OncologyClinical Site ResearchBudget ManagementProtocolEdcCtmsClinical TrialsHigh Learning AgilityPharmaceutical IndustrySopFdaRisk MitigationClinical Trial Management System (Ctms)Strategic Decision MakingProposal DevelopmentRegulatory AffairsDrug DevelopmentGcpU.s. Food and Drug Administration (Fda)Infectious DiseasesNeurologyProcess ImprovementProject Portfolio ManagementPharmaceutical SalesGlobal Business AcumenMarket AccessCROClinical DevelopmentDiabetesValidationCritical AnalysisProblem SolvingGlobal Submission ExperienceStudy CoordinationRegulatory SubmissionsLeadershipClinical Research

ABOUT CYNTHIA SANDY

CLINICAL PROJECT MANAGER | CONSULTANT | GROUP LEADER/ MANAGERSeasoned and experienced Senior-Level Clinical Project Manager skilled in providing leadership in the management of multiple Phase II-IV international clinical trials. Knowledge of therapeutic areas includes neuroscience, urology, cardiovascular and autoimmune disorders. Expert at coordinating all trial activities via cross-functional departments and vendors according to the contract and scope of work. Proven accountability in the global regulatory submission process and in the successful development, management, execution and completion of clinical trials. Drives to and achieves deadlines while remaining on-budget. Leads cross-functional teams as the primary study contact for timeline, scope, and budget. Successful as an effective coach and leader to direct reports and proficient in managing virtual and remote teams. Equally successful as a manger and as an independent contributor.• Leadership –Successfully supervising and overseeing large, complex global programs and projects. Lead cross-functional, global teams and managing multi-million dollar budgets (i.e.$800M). Skilled at problem solving and continual process improvement. • Subject Matter Expert – Routinely recognized as an internal authority at Eli Lilly and sought out as a point of reference and advisor on multiple clinical topics including global regulatory submissions, budget variances, and team and program management. Pursued for participation in many company Six Sigma efforts. • Global Submission Experience – Spearheaded clinical trial programs that resulted in marketing approvals on three successful submissions. Served as the submission project manager lead on the global submission team for Prasugrel when it was the top research and development priority.

This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.