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Job Details

Study Delivery Excellence Lead / Senior Project Manager

Company: SynteractHCR Deutschland GmbH
Location: Brussels, Belgium
Reference: 26861
Closing Date: 04 Dec 16
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

Study Delivery Excellence Lead / Senior Project Manager (m/f) Brussels   SynteractHCR is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development, located in EU, RUS, US and South America. We are looking for a dedicated Senior Project Manager that has a focus on Risk Management and Compliance topics.

Requirements:

Study Delivery Excellence Lead / Senior Project Manager (m/f)

Brussels

 

SynteractHCR is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development, located in EU, RUS, US and South America. We are looking for a dedicated Senior Project Manager that has a focus on Risk Management and Compliance topics.

Your tasks

Support the Clinical Operations team with ICH/GCP expertise, regulations advice and act as a valuable member for clinical decision making that also influences operational efficiencies, effectiveness and business decisions. Support the implementation of the Internal Control Framework.

 

Other responsibilities are providing guidance and hands-on advice in the day to day activities to teams in:

  • Risk management oversight: facilitation of the clinical studies and the end-to-end clinical trial development process including performance management
  • Risk-based management monitoring (Quality Control): deployment / coordination
  • Act as a training partner: ensuring training operational excellence
  • Audit & Inspection activities: support preparation, conduct, follow-up
  • CAPA coordination and management following monitoring (business or independent)
  • Coordination and support of issue / escalation management
  • Contribute to the development, improvement & simplification of standards and processes.
  • Ensure that standards and processes are implemented globally with a high level of compliance and quality

Maintain ongoing communication with designated members from different departments to address risk management issues, to align corporate initiatives, to ensure end-to-end cross-functional approach, to work on trends, problems, issues, and other clinical monitoring opportunities in an efficient way.

Qualifications

  • University Degree in life science / healthcare required
  • A minimum of 6-10 years of relevant experience in clinical development
  • Investigation and negotiation skills, develop and implement new procedures when needed as well as predisposition to quality management, project management and process improvement.
  • In depth knowledge of regulatory guidelines, ICH/GCP and Epidemiology guidelines.
  • Ability to work well within a matrix environment
  • Effective ability to prioritize tasks and deliver on deadlines, with high performance standards and a commitment to excellence.
  • Excellent English language skills (verbal and written)

To apply

Have we sparked your interest? Then we are looking forward to receiving your application! Please apply through our homepage synteracthcr.com and state your earliest start date/notice period and your desired salary. If you have any questions regarding the position please contact antonia.schultze@Synteracthcr.com

 

 


Apply for this job: Study Delivery Excellence Lead / Senior Project Manager

Contact Information:

Address:  SynteractHCR Deutschland GmbH
Albrechtstrabe 14
80636 Munich
Germany
Tel:  +49 89 12 66 80 0
Fax:  +49 89 12 66 80 2444
Website:  Visit Our Web Site

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