Job Detail

Associate Clinical Research Specialist

Inseriert am: 17.06.2021
Careers that Change Lives

We offer you a diverse position in the Diabetes Clinical Research Team, which has the primary mission to generate and disseminate clinical evidence on the safety, efficacy and value of Medtronic Diabetes medical devices.


As a member of the Clinical Research team you will contribute to coordination , planning and execution of clinical studies within Europe, the Middle East and Africa (EMEA), and being responsible for one or more of the following activities:


Please note that the preferred locations should be : Switzerland (Tolochenaz), Netherlands (Maastricht) or Italy (Milan), open for remote job.


 


A Day in the Life



  • Coordination and execution of operational aspects of clinical trials in conjunction with Clinical Study Manager and project team and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, and preparation of clinical trial budgets.

  • Development and maintenance of Trial Master File and study trackers (e.g. CTMS) to ensure completeness for audit/inspection readiness and contribute by performing ongoing quality checks/review.

  • Management of clinical supplies and device accountability

  • Coordination of sites and vendors selection

  • Coordination of start-up activities and site management activities to ensure timely completion of the study (working closely with the study manager and monitoring team)

  • Actively participates to Investigators meeting preparation and presentations and in Site Selection Visits (SSVs) and Site Initiation Visits (SIVs), as necessary.

  • Planning and coordinating clinical study team training, hospital staff training and (investigator) meetings

  • Reporting on progress of the clinical study

  • Partnering closely with cross-functional project teams, e.g. Reimbursement & Health Economics, Regulatory Affairs and Quality, Marketing and Sales, as needed.

  • Collaboration with key opinion leaders

Must Have: 

  • Bachelor or Master of Science degree or equivalent University degree in life sciences or healthcare

  • Minimum 2 years of experience in clinical operations and/or study management

  • Strong project coordination skills with attention to detail

  • Problem solving mindset, pro-active attitude, and capable to work with limited supervision in a remote working environment

  • Able and willing to strictly follow procedures/SOP's and regulations

  • Flexible and strong ability to adapt to change

  • Team player

  • Able to manage multiple tasks

  • Willing to travel


 

   About Medtronic



Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.



We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future. Additional Information

  • Posting Date: Jul 1, 2021

  • Travel: Yes, < 25 % of the Time

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