Senior Clinical Research Specialist

A Day in the Life

The ICT portfolio delivers differentiated cardiovascular technologies that help clinicians detect and manage cardiac conditions earlier, treat patients more effectively, and improve outcomes. This position will be based in Mounds View, MN.

The Senior Clinical Research Specialist oversees, designs, plans and develops clinical evaluation projects. Conducts clinical studies in compliance with applicable clinical and regulatory standards and in alignment with Medtronic business needs. Serves as medical/scientific consultant to clinicians, marketing or research project teams, development, and government regulatory agencies. Monitors and/or interprets results of clinical investigations in preparation for new-drug or device application and/or publications.

Responsibilities

• Develops or provides input into required clinical documents (clinical strategy, Clinical Investigational Plan, study objectives, study budget and project schedule, study training materials, and study reports) in collaboration with investigators and the cross-functional study team.
• Participates in identification of data collection and data reporting requirements to assure clinical study objectives are achievable.
• May drive collaboration of study leadership team to assure high quality and successful project delivery.
• Interfaces with key functional areas to align the clinical study with needs for other business areas (Marketing, research, regulatory, development, patient management, reimbursement).
• Develops therapeutic and device operation knowledge and applies this knowledge to clinical study processes.
• Facilitates meetings with health care professionals, consultants and internal scientific or tactical committees.
• Critically evaluates study progress and metrics.
• May collaborate with cross functional team to identify risks and mitigation plans.
• Participates in process improvement initiatives.
• Reviews and approves required documents for study start, assures continued validity of such documents, takes actions for updates and/or replacements, and monitors site activation.
• Performs site initiation activities, resolution and follow-up of site issues, and study closure activities.
• Provides support and training for clinical study sites to assure data integrity and protocol compliance.
• Prepares study materials and/or training and tracks and maintains study documentation.
• Sets up and maintains accurate clinical study files.
• Coordinates activities of associates and investigators to ensure compliance with CIP and overall clinical objectives.
• Cultivates strong relationship with clinical investigators and site staff.

Minimum Requirements

• High School Diploma (or equivalent) AND minimum 8 years clinical trial experience; OR
• Associate's Degree AND minimum 6 years clinical trial experience; OR
• Bachelor's Degree AND minimum 4 years clinical trial experience; OR
• Advanced Degree AND minimum 2 years clinical trial experience

Preferred Qualifications

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