Accountable for the execution and oversight of local operational start up clinical trial activities in compliance with ICH/GCP and US regulations.
Develop new, innovative strategies and approaches for site validation and engagement (including site scouting).
Ensure adherence to company policies and procedures with quality standards internally and externally.
Oversee teams and functions critical to clinical trial start-up and site engagement.
Manage a subset of CRA Managers and CRAs who are dedicated to validating clinical trial sites.
Establish procedures and processes for all relevant activities (managing site contracts and budget negotiation and escalation, regulatory submissions and approvals).

15 years of experience within the Pharmaceutical Industry of which at least 12 years of experience are in a clinical trial organization including experience in all clinical trial startup and ongoing management activities and processes.
7 years of experience in a functional management position
Expert knowledge of clinical trial regulations (FDA, EMA, ICH-GCP) and site activation processes.
Knowledge of clinical trial operations from a clinical research site perspective
Proven ability to manage complex projects, drive results, and influence cross-functional teams.
Exceptional communication, negotiation, and stakeholder management skills.
Strong analytical and problem-solving abilities.

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

Executive Director, Site Study Start Up and Innovation Head

Key skills