Project Manager Clinical Trials in Germany

 KLIFO GmbH  München
KLIFO A/S is expanding and just established its first subsidiary outside Denmark in Munich, Germany. KLIFO GmbH now wants to appoint a Project Manager for the conduct of clinical trials into a dynamic and experienced team within Clinical Operations Solutions in its Munich office. The people we want to engage like to work in a consulting environment and have a positive, proactive, flexible, self-driven and  selfconfident 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.

KLIFO is a service provider of drug development competences and operational services to the pharmaceutical, biotech and med-tech companies in Europe, US and Asia. The areas covered by KLIFO include Clinical Trial Supply Solutions, Clinical Operations Solutions, Pharmacovigilance Solutions, Regulatory Affairs Solutions, CMC Development Solutions and Drug Development Counselling.

Activities and responsibilities

The Project Manager is overall responsible for managing the clinical trials, i.e.:
  • Management of assigned trials in all phases, from start-up to the end of the project, both as overall project manager in close collaboration with the sponsor and as local project manager faithfully managing the local study responsibilities in the context of a larger study setting
  • Leadership of people involved in the project (CRAs, CTA, etc.)
  • Training and supervision of external staff and subcontractors
  • Investigational site selection in order to assure the quality and conformity of the sites
  • Coordinating cross-functional project teams in relation to trial(s)
  • Operational and scientific input to key project documents
  • Continuous relationship with the Principal Investigators and Sponsor to assure the success of the trial in terms of enrolment and quality
  • Management and resolution of issues occurring during the trial
  • Generation and management of Project Plans
  • Coordination and Implementation of Risk Management Activities
  • Training of Investigators and Monitors and organization and conduct of appropriate meetings
  • Elaboration of trial specific procedures
  • Monitoring of selected sites, e.g. KoL

Qualification profile

The Project Manager should possess the following qualifications:
  • MSc in the life sciences field or a medical/veterinary degree and at least 5-6 years overall experience out of which 2 years in project management in the pharmaceutical industry/BioTech/CRO
  • Extensive knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Demonstrated project management skills including the ability to plan and conduct an international, multicountry clinical trial and operate within plan and budget
  • Willingness to travel
  • Excellent verbal and written communication skills
  • Computer skills, ability to develop and maintain excel spreadsheets and to generate PowerPoint presentations.
  • Fluent in English and in German (spoken and written)
In addition to the above-mentioned qualifications the ideal candidate is a dedicated and collaborative team player.

Benefits

  • 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. KLIFO GmbH is located in 80339 Munich, Heimeranstr. 35, Germany. Further information about KLIFO A/S and GmbH can be found at www.klifo.com.

Send application to

For more information, please contact Doris Wiegel, Managing Director of KLIFO GmbH, at +49 89 89 52 86 0.

While applying for the job please refer to jobvector and use the following reference number: [JV]- Project Manager Clinical Trials (DE)

About KLIFO GmbH

KLIFO – An integrated drug development consultancy KLIFO is a leading drug development consultancy with significant experience in partnering with biotech and pharmaceutical companies to advance their drug development projects. At KLIFO, we offer cross-functional consulting and operational solutions spanning all areas of clinical research, clinical trial supply, CMC development, regulatory...

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