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Job Details

Start-up Specialist I (Paris, France)

Company: Covance
Location: Paris, France
Reference: 2018-19131
Closing Date: 25 Jul 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.

Requirements:

Job Overview

You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance’s impressive history of company stability and growth. We’ve achieved these results by fostering a work environment that encourages, develops and leverages our team’s capabilities. 

We are currently looking for Study Start-Up Specialist I to join our start-up team in Paris, France.

 

Resposibilitites 

 

  • Delivery of the Global Site Services (GSS) component of assigned studies within a country or globally. Including accountability for delivery to time, cost and quality for assigned activities
  • Primary contact with investigative sites during site start-up activities
  • Responsible for working with investigative sites to collect the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by local regulations, EU Clinical Trial Directive, ICH-GCP, FDA regulations (for IND studies) and/or the study sponsor
  • Responsible for maintenance of site address and personnel information in the study database as well as maintenance of regulatory documents throughout the duration of the clinical trial.
  • Work with staff in Operational Strategy & Planning, Business Development and Operations, to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global clinical trials
  • Where applicable, provide logistical support of clinical trial supply coordination

Education / Qualifications

  • University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)

Experience

  • Minmum 1 year of work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulation
  • 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 (Paris, France)

Contact Information:

Address:  Covance- Munich


Germany
Tel: 
Fax: 
Website:  Visit Our Web Site

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