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Senior Study Start Up Specialist - Denmark

Employer
Labcorp
Location
Denmark
Salary
Competitive
Start date
8 Jan 2022
Closing date
24 Jan 2022

View more

Discipline
Clinical Research, Study Start Up
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details


labcorp Drug Development is looking to recruit a Study Start-Up Specialist in Denmark within our Clinical Operations department.

This role will involve dealing with the contract, budgets and submissions so a wider than average start-up position. We can potentially consider a Study Site Co-ordinator from a hospital environment or even a CRA looking for less travel. There are 3 in the Danish team currently so a close-knit working environment.

Key Responsibilities:

  • Collect, track and perform a quality review of all essential & 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 in accordance with client expectations, ICH/GCP, SOPs, budget, quality and applicable laws and guidelines
  • Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.
  • With guidance from line manager and experienced colleagues, adapt Informed Consent Forms and other patient facing material to country specific requirements.
  • May support / assist the contract negotiation process under supervision of an experienced colleague or line manager.
  • 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 documents are filed and systems are updated on an ongoing and timely basis making Covance ready for an audit at any time.
  • Undertake ta sks delegated by senior team members, depending upon country and situational requirements with proper supervision.
  • Perform other duties as assigned by management.

Other Information:

This role is a full time & permanent position to be employed by Labcorp. For more information please contact Andy Smith on +44 (0) 7775 848 250 or mail andy.smith@covance.com
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:
  • experience with start up activities , or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
  • Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines. Demonstrated basic understanding of the clinical trial process

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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