Clinical Data Manager

vor 4 Wochen

YverdonlesBains, Schweiz Symbios Orthopédie SA Vollzeit

Job description:

The Clinical Data Manager supports the department by executing sponsored clinical studies, from clinical data collection in clinical studies to delivery of statistical analysis in support of regulatory activities. Its role is to evaluate dataflows and data integrity according to the EU Medical Device Regulation, and to establish the data management activities to ensure the delivery of high quality data and adherence to study milestones. Clinical Data Manager also expands the scope of Data Management beyond the study construct by requiring the ability to generate knowledge and insights from clinical data to support other clinical research activities which requires different expertise, approaches, and technologies. This is a pivotal role which has been set to support the Clinical Affairs team in Clinical Research, Post-Market Surveillance and Clinical Evaluation activities, where required, and based on priorities.

Responsibilities :

  • Support operational execution of global clinical trials following ISO 14155 requirements
  • Develop and review key deliverables such as Case Report Form, Data Management Plan, Data Validation Plan writing and programming, Data Transfer Agreement, in compliance with international regulatory guidelines and internal SOPs.
  • Perform and oversee the development and validation of the clinical database, execution of the user acceptance testing, data cleaning and quality control.
  • Review and provide feedback on key clinical study documents to support the Clinical Affairs Manager
  • Ensure operational support of clinical study teams including the follow up on open action items
  • Act as the primary point of contact for Data Management with the study teams, CRO and external vendors, the Data Scientist will coordinate the data management activities for outsourced clinical studies.
  • Design and specify data reporting needs and dashboard to ensure high quality data acquisition and smooth data review.
  • Support the Clinical Affairs Manager to allow timely responses to Notified Bodies, Competent Authority, physicians, and other stakeholders involved in Clinical activities.
  • Provide continuous scientific and process improvement (ex. SOPs, WI, Forms.)

 

Qualifications & Required Knowledge, skills & Experience:

  • Master’s degree in Medical Technology, Life Sciences, Clinical Affairs, or Engineering (or equivalent work experience in similar function)
  • Good knowledge of the ISO 14155 requirements as well as EU Medical Device Regulation (EU) 2017/745 and European Medical Device Directive 93/42/EEC
  • Minimum 7 years of experience in a similar position, including at least 3 years of experience in a medical device field specifically with data management and clinical affairs
  • Strong organizational and planning skills, action oriented, focus urgency and drive for results
  • Ability to work autonomously, exercise daily judgment based on above regulatory knowledge
  • Orientation for work result details, with emphasis on accuracy and completeness
  • Fluent in English (minimum C1) and intermediate French level are required
  • Good general computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)
  • Ability to cope with high workload and pressure
  • Solution-oriented and performance-minded working method
  • Ability to travel occasionally

 

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