Covance Start-up Specialist I in Paris, France

Job Overview

COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.

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 Covance, Paris.

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

Job Number 2018-19131

Job Category Other

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.