Merit Medical Systems
Senior Clinical Evidence Specialist
Merit Medical Systems, South Jordan, Utah, United States, 84095
Why Merit?
At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.
WORK SHIFT
DAY (United States of America)
SUMMARY OF DUTIES This position develops, documents and executes post-market clinical follow-up in alignment with the clinical evidence strategies in coordination with cross-functional teams and key product platform stakeholders. Responsible for postmarket clinical follow-up plans (PMCFPs), detailed data analysis and reconciliation, and postmarket clinical follow-up evaluation reports (PMCFERs). Also responsible for the creation and maintenance of related procedures, templates, and processes related to postmarket clinical follow-up activities. Engages with Quality Assurance and Field Assurance to address any identified safety or product performance issues. This role will also assist in directing the work of other clinical evidence specialists as delegated by management.
ESSENTIAL FUNCTIONS PERFORMED 1. Independently researches and prepares PMCF plans and reports, including data synthesis, reconciliation analysis. 2. Coordinates with medical writers on key PMCF deliverables supporting clinical evaluation updates. 3. Participates in the development of pre-market and post-market clinical evidence strategies in coordination with cross-functional teams. 4. Supports product development teams on issues relating to pre-market and post-market clinical evidence needs and strategies for global markets. 5. Proactively identify and address data gaps. 6. Build relationships with key stake holders and ensure clear understanding of responsibilities and deliverables for PMCF activities. 7. Work with key stakeholders and meet PMCF activity deliverables. 8. Create PMCF Evaluation Reports to document the outcomes of PMCF activities. 9. Draft and assemble documentation as required for internal records and regulatory submissions. 10. Work independently to balance competing priorities and drive results with limited supervision. 11. Performs other duties and tasks, as required. ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS * Lifting -- Not to exceed 50 lbs. - local practice may apply. * Writing * Sitting * Standing * Bending * Visual acuity * Color perception * Depth perception * Reading * Field of vision/peripheral
SUMMARY OF MINIMUM QUALIFICATIONS * Education and/or experience equivalent to a Bachelors' Degree in the medical, nursing, biological, physical or engineering disciplines. * A minimum of five years of clinical research, clinical study, clinical data synthesis/analysis and/or clinical writing experience in the medical device field, preferably related to PMCF data collection and reporting. * Knowledge of regulatory requirements relative to clinical investigations in at least one of the following regions: US, EU, other International (e.g., U.S. FDA regulations, the Medical Devices Directive [93/42/EEC, as amended], EU Medical Device Regulation [2017/745] and ISO 14155 Clinical Investigations standard). * Experienced in searching medical literature and databases such as Embase for clinical and technical information. * Ability to read, analyze, and interpret clinical literature, regulations, guidance documents, clinical and medical terminology, technical product information and complex documents. * Effective written and verbal communication skills in the area of technical/clinical applications. * Strong command of medical and surgical terminology. * Working knowledge of statistics and their application to clinical studies. * Self-motivated, self-directing, strong attention to detail and excellent time management skills. * Project management skills. * Demonstrated computer skills preferably spreadsheets, word processing, internet research and other applicable software programs. PREFERRED QUALIFICATIONS * Advanced degree in a medical or scientific discipline (e.g., PhD, MSN). COMPETENCIES * General technical and/or medical device knowledge * Medical/technical writing and data synthesis * Medical device clinical research and/or clinical data analysis * Clinical study design * Medical literature research skills * Computer skills * Interpersonal/verbal/written communication skills * Project management skills * Statistical knowledge/application COMMENTS Infectious Control Risk Category III: The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure. As an eligible Merit employee, you can expect the following: * Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights * Medical/Dental & Other Insurances (eligible the first of month after 30 days) * Low Cost Onsite Medical Clinic * Two (2) Onsite Cafeterias * Employee Garden | Gardening Classes * 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays * 401K | Health Savings Account To see more on our culture, go to www.merit.com/careers. Military Veterans are encouraged to Apply. Merit is a proud Utah Patriot Partner committed to hiring our Veterans.
SUMMARY OF DUTIES This position develops, documents and executes post-market clinical follow-up in alignment with the clinical evidence strategies in coordination with cross-functional teams and key product platform stakeholders. Responsible for postmarket clinical follow-up plans (PMCFPs), detailed data analysis and reconciliation, and postmarket clinical follow-up evaluation reports (PMCFERs). Also responsible for the creation and maintenance of related procedures, templates, and processes related to postmarket clinical follow-up activities. Engages with Quality Assurance and Field Assurance to address any identified safety or product performance issues. This role will also assist in directing the work of other clinical evidence specialists as delegated by management.
ESSENTIAL FUNCTIONS PERFORMED 1. Independently researches and prepares PMCF plans and reports, including data synthesis, reconciliation analysis. 2. Coordinates with medical writers on key PMCF deliverables supporting clinical evaluation updates. 3. Participates in the development of pre-market and post-market clinical evidence strategies in coordination with cross-functional teams. 4. Supports product development teams on issues relating to pre-market and post-market clinical evidence needs and strategies for global markets. 5. Proactively identify and address data gaps. 6. Build relationships with key stake holders and ensure clear understanding of responsibilities and deliverables for PMCF activities. 7. Work with key stakeholders and meet PMCF activity deliverables. 8. Create PMCF Evaluation Reports to document the outcomes of PMCF activities. 9. Draft and assemble documentation as required for internal records and regulatory submissions. 10. Work independently to balance competing priorities and drive results with limited supervision. 11. Performs other duties and tasks, as required. ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS * Lifting -- Not to exceed 50 lbs. - local practice may apply. * Writing * Sitting * Standing * Bending * Visual acuity * Color perception * Depth perception * Reading * Field of vision/peripheral
SUMMARY OF MINIMUM QUALIFICATIONS * Education and/or experience equivalent to a Bachelors' Degree in the medical, nursing, biological, physical or engineering disciplines. * A minimum of five years of clinical research, clinical study, clinical data synthesis/analysis and/or clinical writing experience in the medical device field, preferably related to PMCF data collection and reporting. * Knowledge of regulatory requirements relative to clinical investigations in at least one of the following regions: US, EU, other International (e.g., U.S. FDA regulations, the Medical Devices Directive [93/42/EEC, as amended], EU Medical Device Regulation [2017/745] and ISO 14155 Clinical Investigations standard). * Experienced in searching medical literature and databases such as Embase for clinical and technical information. * Ability to read, analyze, and interpret clinical literature, regulations, guidance documents, clinical and medical terminology, technical product information and complex documents. * Effective written and verbal communication skills in the area of technical/clinical applications. * Strong command of medical and surgical terminology. * Working knowledge of statistics and their application to clinical studies. * Self-motivated, self-directing, strong attention to detail and excellent time management skills. * Project management skills. * Demonstrated computer skills preferably spreadsheets, word processing, internet research and other applicable software programs. PREFERRED QUALIFICATIONS * Advanced degree in a medical or scientific discipline (e.g., PhD, MSN). COMPETENCIES * General technical and/or medical device knowledge * Medical/technical writing and data synthesis * Medical device clinical research and/or clinical data analysis * Clinical study design * Medical literature research skills * Computer skills * Interpersonal/verbal/written communication skills * Project management skills * Statistical knowledge/application COMMENTS Infectious Control Risk Category III: The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure. As an eligible Merit employee, you can expect the following: * Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights * Medical/Dental & Other Insurances (eligible the first of month after 30 days) * Low Cost Onsite Medical Clinic * Two (2) Onsite Cafeterias * Employee Garden | Gardening Classes * 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays * 401K | Health Savings Account To see more on our culture, go to www.merit.com/careers. Military Veterans are encouraged to Apply. Merit is a proud Utah Patriot Partner committed to hiring our Veterans.