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Job Details

Project Coordinator

Company: CROMSOURCE
Location: Germany
Reference: HQ00001385
Closing Date: 20 Aug 18
Type: Permanent
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

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Job Summary:

Job Title: Project Coordinator   Location: Aachen OR Munich, Germany   Schedule: Full time, permanent     CROMSOURCE is urgently seeking a Project Coordinator to join our Project Management team in Germany. The role will be responsible for supporting Project Managers on assigned projects and for performing regulatory submissions, and will be working on both drug and medical device studies.

Requirements:

Job Title: Project Coordinator

Location: Aachen OR Munich, Germany

Schedule: Full time, permanent

CROMSOURCE is urgently seeking a Project Coordinator to join our Project Management team in Germany. The role will be responsible for supporting Project Managers on assigned projects and for performing regulatory submissions, and will be working on both drug and medical device studies.

Main Job Tasks and Responsibilities

  • Manages and coordinates the assigned clinical projects under the supervision of the Project Manager (PM)/ Senior Project Manager (SPM)
  • Manages all project specific services required by the Sponsor (centralized lab exams, drug shipments, documents shipment, etc.)
  • Manages the correct development of the clinical project, interacting with the Sponsor and the Investigators under the supervision of the PM/SPM
  • Keeps him/herself professionally abreast of all scientific, regulatory and operative aspects relevant to the clinical projects he/she will be assigned
  • Should be knowledgeable, following appropriate trainings, in the application process for clinical studies, in force in the country(ies) of work. Accordingly he/she can be required to provide updates on the topic, whenever relevant
  • Collects and manages study data documentation (CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, correspondence, etc.)
  • Collaborates with the Clinical Trial Administrators (CTAs)/Clinical Research Associates (CRAs)in terms of local authorities approval activities
  • Collaborates with the CTAs in archiving activities
  • Organizes and participates in Monitor's and Investigator's Meetings
  • Takes part in the periodic project update meetings
  • Informs PM/SPM about any issues
  • Performs, if necessary, co-monitoring visits for the assigned clinical projects
  • Carries out, after appropriate and documented training/past experiences, the monitoring of the sites for the assigned projects, when requested and if applicable
  • May acts as Feasibility Associate (FEA) after appropriate and documented training

Education and Experience

  • University Degree in scientific, medical or paramedical disciplines
  • Previous experience in the clinical research industry, in either a CRA or project coordination function
  • Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
  • Experience in performing submissions to Ethics Committees and Competent Authorities is desirable
  • Advanced in English and local language(s)
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
  • Willingness to travel

If you would like to be considered for this exciting opportunity pleased send your CV directly to myna.yeboah@cromsource.com

Why CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organization who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Keywords

Project Coordinator Lead Clinical Research Associate Project Coordination Germany Munich Submissions Ethics Committee Competent Authority Aachen

Project Co-ordinator

Apply for this job: Project Coordinator

Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
FK9 4TU
Scotland
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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