ALK-Abelló A/S

Senior Clinical Project Manager

Are you driven by clinical development and cross-functional clinical trial collaboration? Do you thrive within a dynamic organization and fast decision processes?

We are looking for a Clinical Project Manager to join our global team of Clinical Project Managers. We are anchored in Global Clinical Development, and responsible for driving forward the global clinical project portfolio of ALK.

Fields of responsibility

As Clinical Project Manager you will lead the cross functional specific trial team, including the CRO in one or more clinical trials. You will ensure timely execution and progress of the clinical trials according to quality standards defined by regulatory, ALK and ICH-GCP. You will be:

  • Overall responsible for trial related activities from start up to reporting of a clinical trial in close collaboration with CROs
  • Leading the trial team to ensure delivery according to the agreed plan (strategy, time and budget)
  • Leading the development of the trial protocol and drive approval by internal review boards
  • Ensuring proper documentation, record management, risk assessment/management as well as establishing adequate trial oversight activities
  • Develop the Trial Oversight Plan, Communication Plan and Monitoring Oversight Plan in close collaboration with Trial Team members
  • Drive selection of CROs and vendors to match the need of the trial and continuously oversee performance of CROs
  • Report on project progress to ALK management

Your qualifications

  • You hold a degree within relevant life-science disciplines
  • You have experience within clinical development and more than 3 years in international clinical trial management. Experience with clinical trial conduct in the USA and experience with FDA requirements would be an advantage
  • You have proven skills from working in a project oriented and international organization
  • You are a team player and enjoy creating synergy working across disciplines
  • You take initiatives and can convert discussions into action
  • You have a can-do mindset which reflects your communication and collaboration
  • You have excellent communication skills in English both written and spoken

We offer

ALK provides a uniquely dynamic and pleasant work environment, combined with inspiring and challenging assignments. Our size allows you to cover broader project manager role and a boarder scope of influence on your designated trials. The results of your efforts will be significant throughout the organization and you will be able to actively influence and challenge the status quo. Our flat structures attract independent individuals who like to be invisible in the feel the progress of the business and enjoy being close to the decision-making process. You will be part of an engaged and informal team who values skill and knowledge creation. We consider our pioneering spirit coupled with our trustworthiness our winning formula. ALK is a health focused organization and our offices offer a green view of the DTU Science Park in Hørsholm.

Application deadline

31 July 2021

Contact

For further information on the position please contact Head of Clinical Project Management, Kashifa Wichmann +45 6191 1062.

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Region:
Region Hovedstaden
Region Sjælland
Job type:
Permanent
Working hours:
Full-time
Working days:
Day
Application deadline:
31/07/2021
Location:
Hørsholm
Company homepage:
http://www.alk.net