Cross-function, operational management of various core groups:
Regulatory, CMC, investigator site selection, study initiation, site monitoring, patient recruitment efforts, pharmacovigilance, safety / microbiology / bioanalytical labs, etc.
Manage and identify outsourcing needs
Facilitate and manage internal and external communications
Data management and quality control
Clinical Study Reports
Bioanalytical / Pharmacology Reports
Data Management Plans
Statistical Analysis Plans
Safety Reporting
Contract budget negotiations
Study oversight in compliance with ICH/GCP guidelines
CLINICAL DOCUMENTS - DESIGN, DEVELOPMENT, REVIEW
Clinical protocols
Investigator's Brochure (including updates)
Clinical pharmacology reports
CSLI / NCCLS Data Package
Package inserts
Medical and scientific writing for regulatory submissions