Covance Start-up Specialist I in Athens, Greece
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.
Education / Qualifications
University degree (life science preferred)
2 years work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRBIIEC regulations
Working knowledge of iCH, FDA, IRB/IEC and other applicable regulations/guidelines
Familiarity with investigator start-up documents
Previous interaction with operational project teams and investigative sites
Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe
Good organizational and time management skills
Excellent communication I writing skills
Strong computer skills with an ability to access and leverage technology alternatives
Abilities to review/analyze relevant data so as to assist in building evidence-based clinical trial strategies
Self-motivation with the ability to work under pressure to meet deadlines
Works well independently as well as in a team environment
Detail and process oriented
Positive attitude and approach
Ability to work independently
Job Number 2018-19989
Job Category Scientific Entry Level
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.