CLINICAL AFFAIRS PROJECT MANAGER

**This will be a local remote position and you must reside within 125 miles of Jacksonville, FL, due to occasional in-office responsibilities.**

Who We Are

At KLS Martin, we offer a unique opportunity to contribute to the success of a dynamic and thriving company whose products are used daily across the world to help surgical patients.

The KLS Martin Group is a worldwide leader in creating surgical solutions for the craniomaxillofacial and cardiothoracic fields. Surgical innovation is our passion, and we are constantly working with surgeons to improve surgical care for their patients. Our product portfolio includes titanium and resorbable implants for reconstruction, innovative distraction devices to stimulate bone lengthening, over 4,000 surgical instruments, and other surgical products designed specifically for CMF and cardiothoracic surgeons.

KLS Martin is an innovative leader in the treatment of CMF deformities and trauma cases. We use Individual Patient Solutions (IPS) by using our proprietary IPS products where CT scans are used to custom design implants that are created specifically for that individual patient. This technology allows our surgeons to provide the best-in-class treatment for their patients.

KLS Martin Guiding Principles

• Established, Privately Held Business Group - Responsive to customers, not shareholders. KLS Martin has manufactured medical products since 1896, and we have sold our products in the United States under the KLS name since 1993. We have always been, and always will be, privately owned.
• Patient Focus - We design products with the patient in mind - CMF, Thoracic & Hand
• Product to Table - Integrated planning, design, manufacturing and distribution process
• Educational Partner - Our primary focus for support is on education
• Inventory Alliance - Inventory management is critical to patient treatment/outcome
• Surgical Innovation is Our Passion - More than just a tagline

What We Offer

• We provide full-time employees with a competitive benefits package, including paid parental leave
• In-house training and professional development opportunities
• A culture of creativity and innovation by drawing on diverse perspectives and ideas to drive surgical innovation

Job Summary

The Clinical Affairs Project Manager is responsible for working with the Global Team to develop and implement clinical research, data collection and market studies for KLS Martin L.P. North America products. Specialized in writing, editing, and reviewing clinical/regulatory documents required to support market approval. Exercises discretion and independent judgement related, but not limited to, domestic and international regulatory submissions and interfacing with regulatory authorities on the submissions.

Essential Functions, Duties, and Responsibilities

• Execute general medical writing, editing, and proofreading activities and systematic literature reviews for development projects.
• This role will represent the company with frontline communication, relaying objectives, and maintaining relationships with investigational sites and is also the key team member that collaborates with a Contract Research Organization (CRO), Regulatory Affairs, Research & Development and Quality.
• Develop clinical strategies, create clinical evaluations, carry out literature research, orchestrate clinical investigations, as needed, and monitor devices in the market to ensure compliance in throughout the product life cycle.
• Responsible for post-market compilation and reporting
• Ensure documents are produced in accordance with standard operating procedures, internal and external guidelines and company templates.
• Participate in regulatory audits related to clinical evidence.
• Provide strategic direction to the research and development team with respect to clinical trials/research and data collection activities.
• Design, develop, document, and maintain policies and procedures to ensure that research execution meets Good Clinical Practice guidelines.
• Initiate study development and start up process including reviewing protocols, designing and/or reviewing Case Report Forms, preparing Informed Consent forms, developing study documents, organizing, and presenting at investigator meetings, and working with management on monitoring strategy.
• Assist research and other project team members with additional responsibilities as required.

Educational and Experience Requirements

• Bachelor's degree (e.g., BS, MS, RN, etc.) in a scientific, biological, or medical science discipline and/or regulatory discipline is required. Graduate degree preferred.
• 5 years of experience creating Clinical Evaluation or Literature Reports for Medical Device submissions (including US and Canada)
• Expert understanding of systematic literature review (SLR) methodology and the requirements for the clinical evaluation of medical devices in accordance with the ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice
• Strong understanding and comprehension of medical terminology and statistics

Knowledge, Skills, and Abilities

• Ability to coordinate or manage multiple projects to meet project timelines/milestones.
• Exercises independent judgment with problem-solving skills.
• Ability to understand and discuss relevant clinical data.
• Broad knowledge and understanding of the design and critical review of clinical studies.
• Expert level proficiency with word processing (Word), spreadsheets (Excel), presentation programs (Power Point), scientific search engines (PubMed, Google Scholar), and online journal/conference submission systems
• Solid written and verbal communication skills, analytical ability and problem-solving skills that enable you to work on international cross functional teams
• Strong ability to multitask and work effectively in a fast-paced environment with changing priorities.
• Strong attention to detail and organizational skills

Skill Requirements

• Typing/computer keyboard
• Utilize computer software (specified above)
• Retrieve and compile information
• Maintain records/logs
• Verify data and information
• Organize and prioritize information/tasks
• Advanced mathematical concepts (fractions, decimals, ratios, percentages, graphs)
• Verbal communication
• Written communication
• Public speaking/group presentations
• Research, analyze and interpret information
• Investigate, evaluate, recommend action
• Basic mathematical concepts (e.g. add, subtract)
• Abstract mathematical concepts (interpolation, inference, frequency, reliability, formulas, equations, statistics)

Physical Requirements

• Sitting for extended periods
• Extended periods viewing computer screen
• Walking
• Reading
• Speaking
• Hear/Listen
• Maintain regular, punctual attendance
• Writing

Hazards

• Normal office environment

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

KLS Martin is a drug-free employer