Senior Clinical Research Specialist

Medtronic • Mounds View, MN

1d • $105,600 - $158,400 • Onsite

About The Position

The Senior Clinical Research Specialist oversees, designs, plans, and develops clinical evaluation projects, conducting clinical studies in compliance with applicable clinical and regulatory standards and in alignment with Medtronic business needs. The specialist serves as a medical and scientific consultant to clinicians, marketing and research project teams, development teams, and government regulatory agencies. The role monitors or interprets clinical investigation results for new-drug or device applications and publications, and at senior levels may establish conditions for determining the safety, efficacy, medical usefulness, and marketability of medical device products.

The role supports the ICT portfolio of cardiovascular technologies and is based in Mounds View, Minnesota. Medtronic requires a minimum of four days per week onsite to support professional growth and cross-functional collaboration.

Requirements

• High school diploma or equivalent and at least 8 years of clinical trial experience; or an associate degree and at least 6 years; or a bachelor's degree and at least 4 years; or an advanced degree and at least 2 years.
• For baccalaureate degrees earned outside the United States, a degree satisfying the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
• Roles below Principal level require unrestricted U.S. work authorization at hire and throughout employment; sponsorship is not offered for this role.

Nice To Haves

• Degree in engineering, life sciences, or a related medical or scientific field.
• CCRA certification or SOCRA certification.
• Clinical research or clinical trials experience at Medtronic or in the medical device industry.
• Experience with Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials.
• Experience managing multiple clinical research sites with demonstrated study-execution results.
• Experience in clinical operations.
• Experience developing clinical strategies and study designs.
• Experience working on a global study team.
• Research and Development (R&D) experience.
• Project or program management skills or experience.
• Ability to apply relevant medical-device and clinical-research standards, such as SOPs, GCP, ISO, ICH, FDA, MEDDEV, and MDR.

Responsibilities

• Develop or provide input into clinical strategy, Clinical Investigational Plans, study objectives, budgets, schedules, training materials, and study reports with investigators and the cross-functional study team.
• Participate in identifying data collection and reporting requirements to ensure clinical study objectives are achievable.
• Collaborate with or drive the study leadership team to support high-quality project delivery.
• Interface with Marketing, research, regulatory, development, patient management, and reimbursement functions to align clinical studies with business-area needs.
• Develop therapeutic and device-operation knowledge and apply it to clinical study processes.
• Facilitate meetings with healthcare professionals, consultants, and internal scientific or tactical committees.
• Evaluate study progress and metrics, and collaborate with cross-functional teams to identify risks and mitigation plans.
• Participate in process-improvement initiatives.
• Review and approve required study-start documents, ensure their continued validity, arrange updates or replacements, and monitor site activation.
• Perform site initiation, resolve and follow up on site issues, and conduct study-closure activities.
• Support and train clinical study sites to ensure data integrity and protocol compliance.
• Prepare study materials and training, and track and maintain study documentation.
• Set up and maintain accurate clinical study files.
• Coordinate assigned clinical site staff and investigators to ensure compliance with the Clinical Investigational Plan and overall clinical objectives.
• Build strong relationships with clinical investigators and site staff.

Benefits

• Competitive salary and flexible benefits package.
• Short-term incentive through the Medtronic Incentive Plan (MIP).
• Health insurance.
• Dental insurance.
• Vision insurance.
• Health Savings Account.
• Healthcare Flexible Spending Account.
• Life insurance.
• Long-term disability leave.
• Dependent daycare spending account.
• Tuition assistance or reimbursement.
• Simple Steps global well-being program.
• Incentive plans.
• 401(k) plan with employer contribution and match.
• Short-term disability.
• Paid time off.
• Paid holidays.
• Employee Stock Purchase Plan.
• Employee Assistance Program.
• Non-qualified Retirement Plan Supplement, subject to IRS earning minimums.
• Capital Accumulation Plan, available to Vice Presidents and above or subject to IRS earning minimums.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED