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Job Details

Start-up Specialist I (Athens, Greece) - homebased position

Company: Covance
Location: Athens, Greece
Reference: 2018-19989
Closing Date: 13 Aug 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

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.

Requirements:

Job Overview


We are currently recruiting Study Start-Up Specialist to join the Clinical Operations, internal Covance team, Athens, Greece (homebased position). 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 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

Apply for this job: Start-up Specialist I (Athens, Greece) - homebased position

Contact Information:

Address:  Covance- Madrid


Spain
Tel: 
Fax: 
Website:  Visit Our Web Site

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