Karen Stark

About Karen Stark

Extensive experience in conducting and managing Clinical Research studies in all Phases of Drug Development including Post Marketing Studies (Phase IV). Effectively Manages Investigation Initiated Trials (IITs) for several different therapeutic areas as well as being responsible for Budget management and tracking for large international studies as well as US based studies.Outcomes Research experience working with CRO and conducting/managing retrospective studies.Responsible for the operational oversight of Clinical Development programs and management of CRO Activities across many different therapeutic areas.Experience in Evidence Base Medicine, US/Global Clinical Development and Safety Review as well as Data Clean-up for End of Study Activities in preparation for NDAs.Works effectively with cross functional teams and diverse working teams.Professional background: Registered Nurse BSN: Experience in Cardiac and Intensive Care.Extensive experience with Pharmaceutical Research and Nursing. Currently working in Research Operations and Development; Specialties: Clinical Research Development and Operations:Clinical Pharmacology,Cardiovascular, Metabolism, Anti-infectives, Anti-viral, Neuroscience Speciality Care (Autoimmune); Transplant, Respiratory, Gastrointestinal diseases and all aspects of Safety Reporting.Patient Profile narratives - Medical Writing and Review.Data listing Review and reporting experiences in preparation for NDAs and Annual reports.Looking for consultanting opportunities within the Pharmaceutical Industry preferably in the Northern New Jersey area.

Experience

1. Senior Director of Clinical Operations

   Esperion

   Sep 2017 — Present

Education

• The College of New Jersey

  BSN, NURSING

  1979 — 1983

Skills

• Electronic Data Capture (Edc)
• Edc
• Therapeutic Areas
• Ctms
• Metabolism
• Clinical Development
• Neuroscience
• Clinical Operations
• Regulatory Submissions
• Clinical Research
• Clinical Pharmacology
• Clinical Supervision
• CRO Management
• Pharmacovigilance
• Infectious Diseases
• Phase I
• Vaccines
• Regulatory Requirements
• Ind
• Drug Development
• Ich-Gcp
• Gcp
• Project Management
• CRO
• Endocrinology
• Clinical Monitoring
• Clinical Trial Management System (Ctms)
• Medical Affairs
• Clinical Trials
• Infection
• Clinical Data Management
• Oncology
• Protocol
• Medical Writing
• Biotechnology
• Pharmaceutical Industry
• Drug Safety
• Diabetes
• Neurology