Clinical Research Associate (CRA) - Munich, Germany

Clinical Research Associate (CRA) – Munich, Germany


KLIFO is looking for an experienced Clinical Research Associate (CRA) for our Munich office

The position as Clinical Research Associate:
The CRA has considerable knowledge and is responsible for assistance of the Project Manager and conduct of monitoring activities:

  • Participation in the preparation of trial documents for submissions to Competent Authorities and Ethics Committees/Institutional Review Boards
  • Visiting investigator and investigational site before a specific trial: pre-trial/site assessment visits
  • Performing initiation, routine monitoring and close-out visits
  • Elaboration of trial specific procedures
  • Support to data management activities
  • Continuous relationship with the Principal Investigators and trial staff to assure the success of the trial in terms of enrolment and quality
  • Assist in ensuring site compliance with protocol and trial objectives
  • Work in the clinical trial team, reporting to project manager for trial related deliverables
  • Translation of essential documents
  • Liaison between sponsors, investigators and vendors

Qualifications of the Clinical Research Associate

  • Sc. in the life sciences field or CRA specific diploma
  • Minimum 2 years of experience as CRA within industry/CRO/BioTech
  • Extensive knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Willingness to travel
  • Excellent verbal and communication skills
  • Native speaker of German or comparable level (e.g. able to translate patient documents or ICFs into German, able to talk and email in German with site personnel)
  • Excellent computer skills, ability to develop and maintain excel spreadsheets and to elaborate PowerPoint presentations
  • Strong organizational and planning skills
  • Accurate and precise with attention to details
  • Ability to motivate

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:

This position is office-based at our affiliate in Munich.

Contact:

For more information, please contact Doris Wiegel, Managing Director KLIFO GmbH at +49 89 895286-0.

Applications should be sent to:

moc.ofilk@boj, marked CRA Munich Office.
Wir freuen uns auch über Bewerbungen auf Deutsch.

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: 18 December 2019.

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

View job post as a PDF.


Clinical Supply Coordinator

Clinical Supply Coordinator


KLIFO is looking for a Clinical Supply Coordinator for our Glostrup office

The position as Clinical Supply Coordinator:

As a Clinical Supply Coordinator you will support Clinical Supply Managers and be involved in supply activities, such as:

  • Prepare and approve label text according to Annex 13
  • Order packaging materials and labels
  • Prepare packaging records and other study specific documents
  • Control printed study specific labels
  • Coordinate return and destruction of IMP
  • File GxP documents
  • If relevant; Plan, coordinate and handle smaller clinical trials
  • Coordinate and collaborate with other CMO/CRO’s
  • Ensure high quality level to meet customer and KLIFO requirements

 

The qualifications of the Clinical Supply Coordinator:

An ideal candidate is a person committed to creating and delivering solutions that meet individual customer needs.

Also, the person must have a positive, proactive and flexible personality.

 

Education, experiences, knowledge and skill:

The candidate must have relevant competencies and experiences including:

  • Pharmaconomist or equivalent
  • Experience from the pharmaceutical industry, biotech or CRO, preferably as a Clinical Supply Coordinator or similar
  • Ability to work in a flexible and changing environment
  • A high-quality mindset
  • Ability to prioritise different tasks to meet strict timelines
  • Team oriented personality with high degree of flexibility
  • Good communication skills (written and oral), in both Danish and English

 

We offer:

  • An inspiring working environment in a growing company
  • High job variation
  • High level of influence
  • Salary according to qualifications

 

Location:

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

 

Contact:

For more information, please contact Lotte Harreby, Director at +45 44 222 969 or Pernille Smith, Team Leader at +45 44 222 986

 

Applications should be sent to:

moc.ofilk@boj, marked ‘‘Clinical Supply Coordinator.’

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: 26 November 2019

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