Senior Clinical Safety Specialist
MedtronicAbout the role
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 Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We’re committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.Join our diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day.
Responsibilities may include the following and other duties may be assigned.
- Handling various clinical study assignments, and collaborating with cross-functional colleagues in resolution of strategic and operational issues.
- Develop and execute clinical study specific strategies and operational plans - DMC/CEC charters
- Assure successful conduct of assigned clinical studies consistent with applicable regulations, guidelines and policies. This may involve multiple regulatory requirements
- Work collaboratively / lead study members from the Medtronic Clinical Research Institute
- Develop and update study-related CEC/DMC Charters
- Provide oversight of safety activities and operations functions as well as training/feedback to safety personnel and team members. Liaise to clinical sites, CRO and management, in-house Program Team.
- Interface with cross-functional group
- Determine obstacles, identify solutions, and implement plans in collaboration with the safety and/or study team to meet study objectives, scope, schedules and budget. Enlist support and specify tasks for various clinical and project team members to assure that study deliverables and timelines are met.
- Coordinate clinical activities based on site and study needs and perform other duties as assigned. Ensure adequate documentation and resolution of issues, This will usually involve oversight of CRO monitors, but may require hands-on intervention in cases.
- Conduct trial master file reviews
- Contribute to accurate and timely study status reports to study team and management and follow action items through resolution.
- Maintain documentation to be consistent with regulations and SOPs.
- Collaborate with cross-functional team/CRO in evaluation of safety data, tech support and CEC reconciliation, and data analysis.
- Ad hoc projects as assigned in the optimization of procedures and processes. Identify barriers of inefficiencies to flush out and streamline best practices.
- Actively promote Medtronic’s core mission, corporate strategies, policies, procedures and Code of Conduct.
Must Have: Minimum Requirements
- Bachelors degree required, 4 year of experience OR an Advance degree with 2 years of experience
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.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
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.
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