Kalisha A.

Senior Clinical Project Manager, Gco @Kcr

Arlington, VA, US
MOBILE NUMBERS
+91 *********19

Signup · Get unlimited contacts

WORK HISTORY

Feb 2024 — Present

Senior Clinical Project Manager, Gco @Kcr

View department →

EDUCATION

N/A

The University of North Carolina at Chapel Hill

Master's Degree, Pubic Health/Administration

N/A

University of North Carolina at Greensboro

B.A. Degree, Anthropology and Biology

SKILLS

Clinical Trial ManagementClinical MonitoringGcpClinical ResearchClinical TrialsProject ManagementSupply ChainEdcCgmpCtmsOracleGmpInformMedidataNegotiationFdaSopQuality AssuranceRegulatory AffairsSoftware DocumentationPharmaceutical IndustryBiotechnologyCross-Functional Team LeadershipTherapeutic AreasOncologyDrug DevelopmentPharmacovigilanceProtocolDiabetesIch-GcpU.s. Food and Drug Administration (Fda)Standard Operating Procedure (Sop)Clinical DevelopmentRegulatory SubmissionsCRO ManagementGood Clinical Practice (Gcp)Clinical Trial Management System (Ctms)Electronic Data Capture (Edc)ManagementClinical Operations

ABOUT KALISHA A.

Experienced Global Clinical Program Manager with over 20 years of experience in clinical research and project management for the biotech and pharmaceutical industry. Successfully managed complex global programs and clinical studies (pre-clinical, registry and phases I-IV) for multiple Contract Research Organizations (CROs) and pharmaceutical companies, from study initiation to closure. Strong knowledge of FDA regulations and guidelines for clinical trials, as well as Good Clinical Practice (GCP) standards. Highly proficient in budgeting and financial forecasting, as well as data analysis. Proven record of successful project delivery and the ability to lead and manage multiple work streams and diverse levels of individuals cross-functionally.Key Competencies: • Planning, Organizing, and Execution of Clinical Trial Studies• Project and Program Management• Financial Acumen• Regulatory Compliance• Risk and Mitigation Management• Data and Trend Analysis• Vendor Management

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

Kalisha A. — Senior Clinical Project Manager, Gco at Kcr in Arlington, VA, US | Unifers