Principal Clinical Research Specialist - Robotic Surgical Technologies

Covidien Japan Inc

259d • $134,400 - $201,600

About The Position

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. The Principal Clinical Research Spec 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.

Requirements

• Bachelor's degree required and a minimum of 7 years of clinical research experience or advanced degree with a minimum of 5 years of clinical research experience.

Nice To Haves

• Advanced degree (Masters, PhD or MD) preferred.
• Technical degree defined as engineering, life sciences or related medical/scientific field.
• 7+ years' clinical research experience at Medtronic or within a medical device industry.
• Experience managing clinical research sites with proven results in study execution.
• Experience in medical device clinical product trials and regulations.
• Expertise with Good Clinical Practice (GCPs) and regulatory and compliance guidelines for clinical trials.
• Experience in clinical trial design, as well as managing clinical trials from start to finish.
• Basic understanding of biostatistics.
• Scientifically/technically adept (knowledge of product, clinical therapy, trial design, Good Clinical Practices, and global clinical regulations, including FDA and ISO regulations, ICH guidelines, for devices, biologics, and/or pharmaceuticals.
• Experience facilitating committees (e.g. Clinical Events Committee, Data Safety Monitoring Board, Adverse Events Advisory Committee, etc.) and/or managing vendors (e.g. Contract Research Organizations, Core Laboratories, etc.).
• Demonstrated ability to monitor progress, identify issues, and intervene to remove obstacles, involving the appropriate decision makers.
• Demonstrated ability to identify and adapt to shifting priorities and competing demands, and maintain composure in difficult circumstances.
• Ability to provide performance feedback and ability to appropriately respond to feedback from customers and coworkers.
• Demonstrated ability to motivate and hold individuals accountable to deliverables; ability to actively promote the timely and candid exchange of information and viewpoints; demonstrated active listening skills.
• Willingness to accept challenging assignments and engage in relevant developmental activities.
• Proficient knowledge of medical terminology.
• Demonstrated ability to cultivate relationships with co-workers in a cross-functional environment.
• Demonstrated ability to clearly and effectively communicate verbally and in writing.
• High attention to detail and accuracy.
• Exceptional project management capabilities and proficient use of project management tools.

Responsibilities

• Oversees, designs, plans and develops clinical evaluation research studies.
• 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.
• Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
• Develops study budget and manages study spending to plan.
• Critically evaluates clinical data/information and prepares interim and final reports.
• Oversees and interpret 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.
• Performs risk analysis and develops contingency plans for successful study implementation.
• Ensures site activities in alignment with study milestones (i.e. startup, recruitment, closeout, etc.) and implement contingency plans, as needed.
• May be responsible for clinical supply operations, site and vendor selection.
• 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.
• Represents Medtronic from a clinical research perspective within the country/region and also collects feedback from local customers and authorities.
• Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
• Drives local evidence dissemination & awareness.

Benefits

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus 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: Bachelor's degree