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.

REQUIRED KNOWLEDGE AND EXPERIENCE:

• Bachelor or Master of Science degree or equivalent University degree, preferably in life sciences or healthcare with a minimum 2 years of experience in clinical operations and/or study management (academic or in pharmaceutical or medical device industry).
• Strong project coordination skills with attention to detail
• Able and willing to strictly follow procedures (SOPs) and regulations
• Fluency in English, both in writing and speaking
• Strong team spirit
  Collaborating with diverse stakeholders to achieve shared goals with a creative and flexible mindset, you should approach challenges with a problem-solving attitude and proactively seek solutions. Additionally, strong communication skills are an asset to ensure smooth coordination across teams and projects .

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.

• Create and manage the clinical study files and oversee the organization and distribution of clinical study documents, with high quality standards, per Good Documentation Practice
• Track and file Ethics Committees and Regulatory submissions, study reports, and study documentation based on protocol requirements
• Manage clinical supplies and device accountability while coordinating shipments to hospitals and maintaining tracking
• Compile general and customized reports, perform data review and tracking
• Get a broad practical knowledge of operational systems (eTMF, CTMS, Excel, SAP…)
• Communicate with internal and external contacts. A straightforward communication is key
• Assists with periodic audits of clinical study files for completeness and accuracy.