COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. We have an exciting opportunity available to join our team.
We are currently recruiting Study Start Up Specialist to join the Clinical Operations, internal Covance team, Athens, Greece. We are looking for candidates experienced within: submissions, budget, contract negotiations.
We are looking for people interested in full-time options!
About the Job:
- Collect, review, approve process and track regulatory & investigator documents required for study site activation in accordance with Covance SOPs, sponsor SOPs, GCP ICH guidelines and the Investigator Package Plan
- Review and approve core English patient informed consents for compliance to international requirements and protocol as applicable
- Review and approve core Country patient informed consents for compliance to country requirements and protocol as applicable
- Resolve informed consent and contractual language issues by exercising advanced judgment when interacting with study sites
- Negotiate contracts and budgets with investigative sites within parameters provided by Sponsor
- Liaise with Sponsor and Covance regulatory regarding document submission requirements
- Prepare submission packages to Ethics Committee and Regulatory Authority
- Perform other duties as assigned by management
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.