International Clinical Project Manager (f/m)

 SynteractHCR Deutschland GmbH  office-based (Brussels/Belgium)

International Clinical Project Manager (f/m) (office-based – Brussels/Belgium)

SynteractHCR is an international CRO located in EU, RUS, US and South America. As we are growing we are looking for a committed person to join our team in Brussels. We are looking for a dedicated Clinical Project Assistant who will provide operational and administrative support within international Clinical Trials. We offer you a challenging and rewarding job opportunity in a fast moving, flexible environment and a highly motivated team.
Tasks and Responsibilities
  • Responsible for the day to day management and study operational activities to initiate and conduct clinical, epidemiology and local studies
  • Close collaboration with central study team and local study teams
  • Prepare and perform Study Feasibility assessment
  • Provide input to essential study documents (Protocol, ICF, CRF, Study Report and appendices...)
  • Prepare Monitoring Plan and develop Study Procedures Manual
  • Prepare Investigator/Monitors Meeting and train country staff on study operational procedures
  • Coordination of data cleaning activities. Coordination of lab sample management and ensure in-stream lab data reconciliation.
  • Active participation in Study Risk Assessment, escalate any identified quality issues and ensure action plan is implemented and followed up in a timely manner
  • Review and analyze Key Risk Indicators and monitoring metrics, ensure a local action plan is put in place and escalate as appropriate
  • Ensure collection of protocol deviations and ensure review and analysis of data quality. Escalate as appropriate
  • Ensure appropriate documentation is available in the (e)TMF at all times and ensure archiving for paper files
  • Documentation
Your Profile
  • University Degree in General Science or Life Science Degree.or equivalent
  • 3 years + experience as Senior / Lead CRA or Junior Project Manager
  • 5+ years experience in performing clinical research studies, clinical operation monitoring
  • Very good understanding of the clinical studies , drug development , sample management and other associated process and quality requirements, including ICH/GCP guidelines and SOPs
  • Ability to handle several studies at the same time and to set priorities
  • Strong organization and project management skills, excellent communication skills
  • Ability to coordinate and work within teams and networks across functional and geographical boundaries
  • Effective problem solving, result driven, dedicated and highly motivated
  • Advanced IT skills and knowledge of study related systems/software
  • Excellent English skills (verbal and written)
To apply
Have we sparked your interest? Then we are looking forward to receive your application! Please apply through our online tool and state your earliest start date/notice period and your desired salary:
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Über SynteractHCR Deutschland GmbH

In early 2013, San Diego-based Synteract acquired Munich-based Harrison Clinical Research, forming SynteractHCR, a top tier international contract research organization. Through our expanded capabilities we support clinical trials globally, handling everything from emerging products through post-marketing. SynteractHCR is a full-service CRO with a successful track record of more than two...

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