Senior Clinical Research Specialist – Clinical Scientist
Irvine, Minnesota, United States of America
Full Time
2 days ago
$105,600 - $158,400 USD
Visa Sponsor
Key skills
CRLeadership
About this role
Role Overview
Provides oversight and leadership for the design and implementation of Global clinical development activities in support of specific programs within the Neurovascular portfolio.
Leads clinical science and writing activities for the assigned new product development programs.
Designs clinical strategies for regulatory approvals and market access for NV products.
Manages the evidence life cycle for the NV portfolio.
Accountable for driving and overseeing the assigned clinical strategy initiatives.
Plays an active role in reviewing ongoing study progress and leading certain aspects of data-readiness workstreams within the assigned clinical trial(s).
Sets a 3-5 year vision and strategy for comprehensive clinical evidence strategies that position the overall portfolio for long-term success.
Strategic thought partner within the assigned therapy franchise.
Collaborates with Clinical Operations, Biostatistics lead, and cross-functional teams.
Ensures seamless interaction and knowledge transfer with international colleagues.
Develops and cultivates strong relationships with key academic institutions, hospitals, scientific societies, and associations.
Establishes and monitors high-performance standards and metrics for the assigned portfolio.
Develops clinical documents including clinical research protocols, clinical study reports, clinical evaluation reports, and clinical marketing materials.
Requirements
Baccalaureate degree
Minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience.
Nice-to Have: Clinical Sciences in Medical Devices (especially Neurovascular or other vascular devices), Experience with clinical trials in Medical Devices
Experience working with new product development teams
A self-starter
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
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
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)