Covance

Start-up Associate

BE-Brussels
Job Number
2017-13906
Job Category
Clinical Operations
Position Type
Full-Time

Job Overview

Start-up Associate

 

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

 

We are recruiting for our Clinical Research Team in Brussels and are currently seeking to hire a Start-up Associate to liaise with investigative sites during study maintenance and -when assigned-, site start-up (SSU) activities, with responsibility for collection of the required investigator and regulatory documents to ensure EC applications are made within the timelines agreed with project management and SU team

 

This is a permanent, full time position, based in our office in Brussels.

 

About the Job

Within this position, your duties will include:

  • Ensure documents are filed and systems are updated on an ongoing and timely basis making Covance ready for an audit at any time.
  • Collect and track regulatory & investigator documents required for effective and compliant study site activation and maintenance.
  • Ensure that all assigned maintenance and start up activities  are on track and support study deliverables.
  • Follow up with sites in order to ensure documents required are collected in a timely manner.
  • Escalate study issues appropriately and in a timely fashion.
  • Update study documents when there are changes in study personnel/study amendments.
  • Contribute to the preparation of submissions to IRB/IEC  with appropriate supervision.
  • Ensure high quality site documents are filed in the TMF in a timely manner according to study plans.
  • Undertake tasks delegated by senior team members, depending upon country and situational requirements with proper supervision.
  • Perform other duties as assigned by management.

 

About You

To be successful in this position, you will need to have a 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)

 

Additionally, you will need to demonstrate:

  • Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines.
  • Demonstrated basic understanding of the clinical trial process
  • Team Player
  • Positive attitude and approach
  • Detail orientation
  • Organizational Skills
  • Strong Quality Orientation
  • Delivery to Time lines
  • Accuracy
  • Communication-written and oral
  • Execution
  • Problem Solving

 

We Offer

Covance offers a comprehensive benefits package including health cover and contributory pension.

Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. 

Get ready to redefine what’s possible and discover your extraordinary potential at Covance. Here, you’ll have the opportunity to personally advance healthcare and make a difference in peoples’ lives with your bold ideas and unique point of view. With the support of exceptional people from across the globe and an energized purpose, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.

Join us as we speed the delivery of groundbreaking therapies and anticipate tomorrow’s drug development challenges, creating new possibilities for our clients—and your career.

Education / Qualifications

To be successful in this position, you will need to have a 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

Additionally, you will need to demonstrate:

  • Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines.
  • Demonstrated basic understanding of the clinical trial process
  • Team Player
  • Positive attitude and approach
  • Detail orientation
  • Organizational Skills
  • Strong Quality Orientation
  • Delivery to Time lines
  • Accuracy
  • Communication-written and oral
  • Execution
  • Problem Solving

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