Covance Start-up Specialist I in Athens, Greece

Job Overview

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

Experience

  • 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

  • Multi-tasking capability

  • 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.