Lead CRA


KLIFO is looking for a talented and committed Lead CRA (LCRA) based in Denmark

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

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

  • Performing feasibility and assessing suitability of clinical trial sites
  • Participate in the Risk Based Quality Management (RBQM) process with focus on the monitoring strategy
  • Development and review of Informed Consent Forms
  • Applications to Ethics Committee and review of Regulatory Submission Packages as applicable
  • Review and approval of Regulatory Green Light (RGL packages)
  • Development of study specific plans in cooperation with PM and sponsor
  • Review and approval of monitoring reports from other CRAs
  • Ensure adherence to agreed monitoring visit schedule across all sites
  • Oversight of SDV status, data entry status and data quality standards across sites. Initiate root cause analysis if not on track and escalate to PM
  • Coordinate data cleaning activities in cooperation with data management
  • Plan and lead CRA meetings to ensure knowledge sharing and common monitoring practice / implementation of study specific processes across sites
  • Training and supervision of CRAs in trial specific processes and procedures. Perform co-monitoring visits
  • Day-to-day management of central lab as applicable

The qualifications of the Lead CRA:

  • BSc. 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 as well as in native language (if other than English)
  • Experience with multi-country and multi-centre trials
  • Ability to translate client’s needs into solid deliveries
  • Ability to work independently without supervision of a colleague within the group
  • 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 in Denmark, Germany, Sweden and The Netherlands. This position will be located at our office in Glostrup, Denmark.

Contact:

For more information, please contact Stine Larsen, Director, KLIFO A/S at +45 4422 2959

Applications should be sent to: 

moc.ofilk@boj marked Lead 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:
23 November 2020 (although applications are reviewed on an ongoing basis)

View job post as a PDF.