(Senior) Clinical Project Manager (m/f/d)

Late Stage

We are searching as soon as possible for our pharmaceutical client for a dedicated and highly motivated

(Senior) Clinical Project Manager (m/f/d)

Late Stage

  • Bereich:

    Medical

  • Berufssparte:

    Forschung/Entwicklung

  • Arbeitsregion:

    Großraum Köln

  • Art der Anstellung:

    permanent

  • Kennziffer:

    25172

  • Aktualisierung:

    2019-03-05

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Dann bewerben Sie sich gleich hier Online oder per E-Mail unter Angabe Ihres frühestmöglichen Eintrittstermins und Ihres Gehaltswunsches.


Your responsibilities

  • Lead on or more multi- functional Clinical Study Teams/ Joint Clincal Study Teams
  • Creates, or contributes, to detailed planning of the study timelines, defining critical path, and enabling seamless and timely access to bioanalytical and/ or safety data for review meetings and so allowing prompt decision making
  • Regularly monitor and assess the appropriateness of the risk mitigation plan with the Clinical Study Team(s) / Joint Clinical Study teams and ensure that the cause, impact, remedial actions & preventative steps are assessed for any issues identified to avoid recurrence
  • Work with CRO partners to define a study specific monitoring strategy. Review Monitoring Plans, and CRA generated reports (as appropriate)
  • Provide input to aid in the development of the clinical database, and clinical operations focused review of the clinical database specifications during set-up, and support data cleaning and data evaluation meetings and Results Interpretation Meetings (RIMs)
  • Ensure quality and adherence to the relevant SOPs, GCP, regulatory guidelines and working practices
  • Visit investigational sites and Phase I Units to build and maintain relationships as well as to understand opportunities and challenges to study conduct, including enrollment, when needed for assigned clinical studies

Your qualifications

  • At least three years' relevant experience an project management skills
  • Capability to manage in- house and/ or outsourced regional or global late phase studies
  • Substancial experience in study management in different indications and proven ability to manage complex multinational studies or mutliple simultaneous studies from start to end
  • Motivation, mentoring and integration of individuals on multi-functional international teams
  • Scientific and technical knowledge
    • GCP and regulatory environment
    • Medical knowledge and research expertise
    • Basic principles of data management and statistics
  • Ability to handle detailed technical matters and team dynamics Reconciliation of conflicting priorities
  • Delivery of scientific/medical presentations and training to both large and small audiences
  • Good interpersonal skills
  • Proficiency in the Microsoft office suite

Your contact person

Bettina Cöppicus
Senior Personalberaterin

Anschrift

Optares ICM GmbH & Co. KG
Bettina Cöppicus
Heiligengeist Höfe 8
26121 Oldenburg