Clinical Research Spec

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
The Clinical Safety Specialist is responsible for safety and potential complaint data throughout the clinical study to ensure compliance with respect to the reporting of clinical study safety and potential complaint data to meet regulatory requirements. The DSM Clinical Safety Specialist will partner with various colleagues across Medtronic (e.g., other members of the DSM Clinical Safety team, other DSM functions, Regulatory Affairs, Clinical teams in the Operating Units) to manage adverse event, death, and device deficiency reporting in compliance with applicable regulatory standards and Medtronic internal requirements.

Position Responsibilities may include but are not limited to:
Review and assess clinical study Adverse Events (AEs) including Serious Adverse Events (SAEs) and device deficiencies
* Review non-AE Case Report Forms to detect potential complaint and potential unreported AEs
* Interact with investigational sites and clinical monitors to obtain additional pertinent information as indicated in the Clinical Investigation Plan (CIP)
* Ensure consistency in the assessment of clinical safety events
* Work with Regulatory Affairs and the Product Complaint Reporting teams to ensure timely reporting of AEs, SAEs, and Unanticipated Serious Adverse Device Effects (U[S]ADEs) and potential complaints
* Ensure appropriate distribution and notification of SAEs and U[S]ADEs to appropriate personnel, partners, and investigational sites per CIP
* Act as liaison for safety-related questions (e.g., to study team, field support, monitors, and study sites)
* Author Clinical Safety Management and Potential Complaint Plan (CSMPCP) for assigned studies
* Assist with preparation of assigned section of safety reports for annual reports, clinical study reports, and other documents as required
* Collaborate with Data Management and other departments on the development of case report forms, study specific safety reports, and other study specific forms
* Assist with the writing of safety sections of CIPs and may present Clinical Safety requirements at investigator meetings
* Support study audit for Safety-specific topics
* Facilitate Clinical Event Committee (CEC) work (author CEC charter, review source documents, ensure all CEC events are adjudicated by CEC)
* Support database snapshot activities (e.g., meet with study team, review timelines, perform reconciliation and data cleaning activities to be audit & snapshot ready)
* Prepare, attend and/or lead Safety Trending meetings
* Perform other Clinical Safety tasks as assignedPosition Requirements:This DSM Clinical Safety Specialist position is linked to the Medtronic Job Family 'Clinical Research', more specifically the specialist career stream including the following job codes referring to different levels of maturity: 140720, 140730, 140830, 140850 and 140860. Refer to these Job Descriptions for the position requirements (e.g., Required Knowledge and Experience, Differentiating factors).

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.

Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Netherlands: 52,800.00 EUR - 79,200.00 EUR |
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

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