Senior Clinical Research Associate based in Denmark


KLIFO is looking for a talented and committed Senior Clinical Research Associate based in Denmark

KLIFO is expanding our office in Denmark and wants to engage a Senior CRA 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 Senior CRA:

The Senior CRA is responsible for monitoring activities of trials across several sites and/or countries including pro-active site management and oversight:

  • Development of study specific plans in cooperation with Project Manager and sponsor
  • Prepare trial submission material for applications to Ethics Committee and review Regulatory Submission Packages
  • Performing feasibility and accessing suitability of clinical trial sites
  • Perform site initiation, monitoring and close-out visits
  • Participate in the Risk Based Quality Management process with focus on the monitoring strategy
  • Coordinate data cleaning activities in cooperation with data management
  • Training and supervision of CRAs in trial specific processes and perform co-monitoring visits
  • Function as Lead CRA if a trial has multiple sites including proactive site management and oversights

The qualifications of the Senior CRA:

  • BSc/MSc in the life sciences field or related discipline and a minimum of 3-4 years in a similar position in the pharmaceutical industry/Biotech/CRO
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Willingness to travel
  • Excellent communication skills (written and verbal) in English
  • Experience with multi-country and multi-center trials
  • Ability to translate client´s needs into solid deliveries
  • Ability to work independently
  • Ability to supervise and coach non-senior personnel within the group

We offer:

  • 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 

Location:

KLIFO has offices Denmark, Germany, Sweden and The Netherlands. This position will be located at our office in Glostrup, Denmark.

Contact:

For more information, please contact Randi Rahbæk, Senior Director, KLIFO A/S at +45 44 778 704

Applications should be sent to: moc.ofilk@boj marked “Senior CRA”.

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:
19 May 2021 (although applications are reviewed on an ongoing basis)

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