Principal Clinical Research Specialist- Surgical Robotics.

Careers That Change Lives

In this exciting role as a Principal Clinical Research Specialist (CRS) in our Surgical Robotics Operating Unit, you will have primary responsibility in the development and execution of global clinical studies.

You will lead study management duties for assigned clinical programs to evaluate performance, safety, and effectiveness of products and to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies conducted globally.

Work with the Clinical Management to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies.

Assumes project management responsibilities for selected studies and site management activities as needed.

Surgical Robotics employees believe that every patient around the world deserves access to quality care and improved outcomes.

Driven by our Mission, we believe that surgical robotics can add value to the healthcare ecosystem, lessen variability, and help more people around the world get better, faster.

We're making that exciting future possible and disrupting one of the biggest and fastest growing markets in healthcare with a game-changing portfolio of robotic and data & analytics technologies, services, and solutions.

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day.

It’s no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

To learn more about Inclusion & Diversity at Medtronic

Preferred location(s) : North Haven, Connecticut or Remote

Ability to travel %. 30% (domestic and international)

A Day in the Life

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

• Oversees, designs, plans, and develops clinical research studies. May be involved in early study development including statistical design of the trial.
• Prepares and authors protocols and patient record forms.
• Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and / or offer a commercial potential.
• Assists in Overseeing and interpreting results of clinical investigations in preparation for new drug device or consumer application.
• Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations and may prepare clinical trial budgets.
• Oversees clinical study operations, including safety, monitoring, data management, and site and vendor selection.
• Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
• Escalates any study issues quickly to leadership and ensures study milestones are met.
• Maintains understanding of regulatory requirements across multiple regions; serves as resource for clinical strategy personnel.
• May represent Clinical Affairs team on certain product core teams providing SME support with clinical requirements in accordance with SOPs and regulations.

Other Responsibilities :

• Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, regional teams, and management.
• Reviews status of projects and budgets; manages schedules and prepares status reports.
• Assesses project issues and develops resolutions to meet productivity, quality, and objectives.
• Develops mechanisms for monitoring project progress and for intervention and problem solving
• Present to and partner with clinical leadership on the overall health of the portfolio, successes, and areas of opportunity.
• Organizational Impact : May be responsible for entire projects or processes within job area.
• Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
• Makes improvements of processes, systems, or products to enhance performance of the job area.
• Analysis provided is in-depth in nature and often provides recommendations on process improvements.
• Exchange information of facts, statuses, ideas, and issues to achieve objective, and influence decision-making.

Must Have : Minimum Requirements

Bachelor’s degree required with a minimum of 7 years of clinical research experience or advanced degree with a minimum of 5 years of clinical research experience

Nice to Have (Preferred Qualifications) :

• Degree in engineering, life sciences, or related medical / scientific field
• 7+ years’ experience managing clinical trials within Medtronic or medical device industry
• Experience working on a global study team
• Experience in Surgical therapies / product
• Experience managing multiple clinical research sites with proven results in study execution
• Experience in managing clinical trial data review
• Basic understanding of biostatistics and trial design
• Experience in Good Clinical Practice (GCP) and / or regulatory compliance guidelines for clinical trials, such as ISO14155
30+ days ago