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Principal Clinical Research Specialist

Mounds ViewMedtronic

The Principal Clinical Research Specialist is responsible for developing strategies and driving processes to meet the milestones of complex clinical studies/projects in compliance with applicable clinical and regulatory standards and in alignment with Medtronic business needs.  This role utilizes their broad range of experience in managing the technical execution of the trial and manages trials of a higher degree of complexity and global nature.  This role works independently and under only general direction.  Major deliverables are reviewed to ensure clinical and business requirements are met.  The position provides work direction and strategic oversight of personnel supporting their trial and may manage a limited number of personnel, when appropriate, based on their individual career interests and Individual Development Plan.
• Provides project and study management and assures successful conduct of assigned clinical studies/projects. 
• Drives process to determine study/project objectives, strategy, scope, and schedule in order to meet business needs.
• Develops the required clinical/project documents (e.g., Investigator Brochure, Clinical Management Plan, Clinical Investigational Plan, CERs) in consultation with the cross-functional team, investigators, and the clinical team.
• Develops therapeutic and device operation knowledge and applies this knowledge to clinical study processes.
• Establishes selection criteria for principal investigators and investigative sites and drives center selection process.
• Responsible for site identification, qualification, initiation, training to ensure study compliance and subject protection.
• Assures training of investigators, center staff and Medtronic clinical staff.
• Ensure accurate inventory accountability of investigative product at clinical sites
• Facilitates meetings with health care professionals for Investigator Meetings, Data Safety and Monitoring Boards/Clinical Events Committees, Advisory Boards / Steering Committees, and Publication Committees.
• Supports and may interact as the clinical representative with regulatory agencies including meetings with the Food and Drug Administration (FDA) and FDA panel meetings, regarding requirements and results of the study.
• Enlists support and provides work direction for various clinical team members to assure timely achievement of milestones and study objectives, including development of a cohesive, high-functioning team.
• Critically evaluates clinical data/information and prepares interim and final reports.
• Performs risk analysis and develops contingency plans for successful study implementation.
• Develops study budget and manages study spending to plan.
• Develops a cohesive, high-functioning team by providing feedback, mentoring, and performance management input for clinical study team members.
• Ensures site activities in alignment with study milestones (i.e. startup, recruitment, closeout, etc.) and implement contingency plans, as needed
• Responsible for accurate and timely adverse event reporting during the study.
• Will ensure site adherence to FDA, ISO, local regulatory, IRB/EC and Medtronic requirements
• Work with investigators to quickly and effectively resolve problems

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