Clinical Evidence Specialist

Supervisor’s Title: Clinical Research Manager
Exempt or Non-Exempt: Exempt

The expected annual base salary range for this Minnesota based position is $80,000-110,000. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s knowledge, skills, and or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Retirement Benefits).

Basic Function

The Clinical Evidence Specialist will combine understanding of medical device regulations and guidelines and product knowledge to support regulatory submissions in the US and Europe. This role will be responsible for supporting clinical activities related to device development during both pre-market and post-market phases. The Clinical Evidence Specialist is recognized as a subject matter expert for guidelines and regulations regarding the clinical evaluation process and its consequent documents (e.g., CEP, CER, PMCF Plan, SSCP and literature review).

Responsibilities

• Oversees the clinical evaluation process for multiple cardiac medical devices in compliance with applicable clinical and regulatory standards and in alignment with business needs
• Provides scientific and/or medical expertise, analytical thought processes and a robust, systematic clinical evaluation approach in order to continuously collect, analyze and assess clinical data on Cardiac Rhythm (CRM) products throughout their lifecycle
• Collaborates with cross-functional teams on establishing clinical safety and performance objectives for medical devices and defining the associated appraisal and analysis plans for various types of data sets across the lifecycle of the medical device
• Plans and develops clinical evaluation plans, reports, post market clinical follow-up plans and reports, summary of safety and clinical performance, and other related deliverables
• Plans and conducts comprehensive literature searches
• Manages project schedules for each document to ensure timely execution
• Communicates cross functionally with multiple stakeholders in the company – including regulatory, marketing, product development as well as external vendors such as CROs and Reviewers
• Interact with regulatory agencies when and if necessary.

Qualifications

• Bachelor’s degree required.
• 2-4 years of clinical/medical/scientific writing experience.
• Strong understanding of regulatory requirements & experience in writing regulatory reports including Clinical Evaluation Report (CER), Clinical Evaluation Pan (CEP), Post Market Clinical Follow-Up (PMCF) Plan.
• Experience in clinical evidence planning and/or development (e.g. identifying data needed to substantiate claims, developing literature search protocols, etc.).
• Experience in cardiovascular disease device therapies preferred
• Ability to conduct complex work under minimal supervision and with wide latitude for independent judgment.
• Experience with start-up or mid-sized company environment preferred.

Working Conditions

• Light work, exerting up to 20 lbs. of force or less.
• 85% of time requires viewing and working at computer screen.
• Significant work pace & pressure due to deadlines.

This position is responsible for complying with the Quality System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

The statements below reflect the principal function and most significant duties of the job as necessary for its evaluation in relation to other jobs in the organization and shall not be construed as a detailed description of all the work requirements that may be inherent in the job. Any functions that are non-Essential will be identified as such below. A request for Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.