Clinical Operations Project Manager


KLIFO is looking for a Clinical Trial Assistant (CTA) for our Glostrup office

KLIFO is expanding and wants to engage a Project Manager with early clinical development experience into a dynamic and experienced team within Clinical Operations Solutions. The people we want to engage like to work in a consulting environment and have a positive, proactive, flexible, self-driven and self-confident personality. We can offer a highly flexible, free and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated. 

The position as Project Manager:

The Project Manager (PM) is responsible for the delivery of an agreed trial as defined in the trial outline/protocol, to the agreed quality, budget and timelines: 

  • Planning, delivery and management of clinical trial activities (start-up, operational conduct and closure) according to SOPs and a responsibility split with Sponsor
  • Lead the clinical trial team and coordinate and manage all activities related to clinical trials in phase I-III
  • Liaison with clinical trial team members regarding trial design and protocol preparation and ensure the production of the final trial protocol 
  • Lead the Risk Based Quality Management (RBQM) process including risk assessment and risk controls 
  • Development of project plans for the conduct of the clinical trial
  • Communicate timelines, identify milestones, handle trial budget and report progress for the clinical trials to sponsor.

The qualifications of the Project Manager:

  • MSc in the life sciences field and a minimum of 5-6 years of overall experience out of which 3 years must be in project management in the pharmaceutical industry/BioTech/CRO
  • Experience with conduct of phase I trials
  • Extensive knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Willingness to travel
  • Demonstrated project management skills including the ability to plan a project and operate within plan and budget
  • Excellent communication skills in English
  • Microsoft Office Skills

We offer:

KLIFO offers a job where you can: 

  • Work within different therapeutic areas and with tasks of varying complexity 
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia) 
  • Build international client relations 
  • Use and elaborate your competences and experience 
  • Work in an interactive, flexible and positive working environment 

As KLIFO is a smaller service provider, you will experience a high level of transparency, influence and a good possibility for individual planning.

Location:

KLIFO has offices in both Denmark, Germany and Sweden. This position is located at our office in Glostrup, Denmark. 

Contact:

For more information, please contact Jennie Wilborgsson, Clinical Research Director, COS, at +45 93 638 820. 

Applications should be sent to: moc.ofilk@boj marked CTA.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR). 

Deadline: 28 February 2020.

View job post as a PDF.

KLIFO is an established and integrated drug development consultancy with offices in Denmark and Germany. We provide end-to-end expert capabilities, enabling our partners to maximise opportunity, mitigate risks, drive innovation and achieve efficient project advancement. Further information about KLIFO can be found at www.klifo.com