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Clinical Project Manager (m/f)

 
 
 
Randstad
Werden Sie Teil des zweitgrößten Personal-Dienstleisters der Welt: Die Randstad Group ist als Global Player in 39 Ländern an 4.400 Standorten mit 609.020 MitarbeiterInnen vertreten.

Als moderner, dynamischer und erfolgsorientierter Konzern übernehmen wir Verantwortung am Markt: für unsere Kunden und MitarbeiterInnen, für die Gesellschaft sowie im NGO- und Sport-Sektor (Official Partner Williams Martini Racing).

Wir leben unsere Werte nach ethischen Grundsätzen den Partnern und MitarbeiterInnen gegenüber – ein Garant dafür ist unsere unabhängige Auszeichnung „Beste Arbeitgeber Österreich 2015“.

As a leading global biotechnology company our client SHIRE has one mission every day: to lastingly improve the lives of people living with rare diseases. Crucial to this mission are the employees - their biggest asset - who enjoy a range of benefits and career opportunities, such as trainee and training programs, job rotations, apprenticeships, work-life balance (certified family friendly), company kindergarten, wellness center, cafeteria, etc.

To further strengthen and extend the local team, we are looking for a Clinical Project Manager (m/f) for our client Shire in Vienna.

Responsibilities:
  • Contributes to the clinical review of CRFs, completion guidelines, and the data review plan
  • Assists and/or participates in planning and conduct of investigator's meetings.
  • Provide status reports to the Clinical Programs Lead (CPL).
  • Provides input and coordinates the delivery of clinical trial supplies in collaboration with clinical supply team.
  • Collaborates with the cross-functional team on selection and potentially management of clinical vendors.
  • Liaises and coordinates with document specialists regarding study files.
  • Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
  • Leads and/or assists in the oversight of CRO activities and other clinical vendors to ensure the quality meets Shire and regulatory requirements.
  • Develops and monitors budget for clinical study (investigational sites and vendors).
  • Monitors the status of clinical data collection of assigned clinical studies.
  • Reviews clinical monitoring reports and correspondence related to monitoring visits.

Requirements:
  • Bachelor's degree is required. Scientific/health care field preferred, but not required.
  • Experience (2+ years) working in clinical research within a pharmaceutical company or CRO or similar organization.
  • Familiarity with financial budgeting and forecasting/reporting.
  • Knowledge of current regulatory requirements and guidelines governing clinical research.
  • Excellent written and oral communication skills.
  • Ability to interact with investigators, vendors, and internal colleagues.
  • Strong knowledge of applicable computer and project management software packages, including Microsoft Word, Excel, Project, and Power Point
  • Requires strong attention to detail and the ability to establish priorities, schedule, and meet deadlines.
  • Ability to work successfully within a cross-functional team and a matrix organization.

The minimum salary for this position is € 3.065,25 gross per month (full-time); increased payment is possible. Due to a maternity leave the contract will be limited until May 2019.

We are looking forward to your application!


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Randstad