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Associate Clinical Safety Coordinator

Medtronic

Bratislava, Bratislava, Slovakia
Unknown
4 months ago
N/A
ExecutiveSource: linkedin

Job Description:

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life Join Medtronic Clinical and Regulatory Solutions (MCRS), a global team driving innovation in life-changing medical advancements. We are looking for a detail-oriented Associate Clinical Safety Coordinator to become part of a global team dedicated to advancing life-changing medical innovations. In this role, you’ll play a pivotal part in ensuring the accuracy and efficiency of clinical safety processes. Your responsibilities will include managing a variety of administrative tasks such as filtering and preparing reports, potential complaint and regulatory reporting, reconciliation activities and filing. In this role, you’ll collaborate with a global team. This position offers the opportunity to contribute to the success of clinical safety operations.

You’ll report to a Netherlands-based manager and have the flexibility to work hybrid, empowering you to tailor your work environment to your needs while supporting Medtronic’s mission to improve patient outcomes worldwide.

Responsibilities may include the following and other duties may be assigned:

  • Ensure that all the Clinical Study reports are run, filtered & prepared as per Clinical Safety Management and Potential Complaint Plans (CSMPCP)
  • Support with gathering and compiling information for reports required for potential complaint and regulatory reporting purposes
  • Support reconciliation activities and run listings for data cleaning in line with study milestones
  • Ensure that all required records are filed in the Trial Master File
  • Manage per Good Documentation Practice (GDP) all relevant Clinical Study files and oversee the workflow and distribution of clinical study documents
  • Support Clinical Event Committee (CEC) preparation and post CEC meeting activities, when applicable
  • Assists with periodic audits by ensuring that the applicable clinical study files are proved for completeness and accuracy.

Required Knowledge and Experience:

  • At minimum high school diploma
  • Practical experience with administrative tasks, operational systems, and processes
  • Strong attention to detail and accuracy
  • Clear and collaborative communication skills
  • Task management; prioritizing
  • Good knowledge of the English language written and spoken.

Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here