Sr. Manager, Clinical Research and Regulatory Affairs - Edmonton, Canada - Pulse Medica

Description

Embark on an exciting journey at PulseMedica Take charge of strategically planning and coordinating the development of clinical research protocols and studies, regulatory path-to-market, managing ethics reviews, and FDA / Health Canada submissions for class II and III medical devices. Play a key role in designing and managing clinical operations, and collaborating with stakeholders. Drive the development of impactful publications and presentations, showcasing the clinical benefits of PulseMedica's groundbreaking technologies. If you're a dynamic leader with a passion for clinical innovation, we want you on our team

Note: While meeting the prerequisites for the Senior Manager role is essential, candidates who exceed these qualifications will be given special consideration for placement into a Director level position.

About Us

PulseMedica, recently certified as a Great Place to Work for the second consecutive year, is a fast-growing disruptive medical device startup company. We seamlessly integrate research, innovation, and production environments. We are determined to help those suffering from eye diseases and disabilities by offering novel treatment options using our state of the art technologies. Our platform combines real-time 3D eye imaging and high precision Femtosecond laser surgery. Our goal is to revolutionize ophthalmic treatments by providing people with exceptional outcomes and, ultimately, changing the world by preventing blindness and disability resulting from eye diseases.

The Opportunity

This position offers a unique opportunity to collaborate with a team of talented and dynamic individuals, collectively shaping the direction of our company's future. You will be paving the path towards FDA and Health Canada approvals for new indications. As the successful candidate, you will be responsible for strategic planning and execution of clinical studies, and the development of the regulatory path-to-market strategy. You will be leading end-to-end submission of class II and class III medical devices, while fostering key relationships with stakeholders. Moreover, you'll be at the forefront of showcasing the clinical advantages of PulseMedica's pioneering technologies through impactful publications and presentations. Working with a medical device startup brings unparalleled opportunities for innovation and growth, making this role a unique chance to contribute to a dynamic and transformative industry.

Responsibilities:

• Strategize and lead the development of pre-clinical and clinical research study protocols, while establishing operating policies.
• Develop, apply, and manage ethics review board applications and correspondence, ensuring compliance with regulations.
• Plan and liaise with regulatory consultants, navigating the path toward Health Canada, FDA, and European approvals, including 510(K) and De-Novo.
• Regularly engage with medical advisory board members, Key Opinion Leaders (KOLs), investigators, and representatives at clinical sites.
• Support the identification of candidate sites for conducting clinical studies and lead the selection of appropriate study sites using objective metrics.
• Prepare comprehensive study documentation such as protocols, case report forms (CRFs), memos, correspondence, reports, and other required documents.
• Implement and maintain data collection and analysis systems in support of research protocols, coordinating the collection and analysis of research data.
• Ensure timely collection of study documentation by obtaining and maintaining all necessary records according to procedures and regulations.
• Lead the training and coordination research site staff to meet specific study objectives and responsibilities.
• Oversee day-to-day operations of quality and clinical research activities, serving as the primary administrative point of contact for internal research staff and as the principal operational liaison for other research organizations, funding agencies, and regulatory bodies.
• Coordinate the activities of technical support staff engaged in research/clinical protocols, performing aspects of research protocol as required.
• Supervise and coordinate support services for investigators and research teams.
• Monitor the progress of research activities, maintain records, and prepare periodic and ad hoc reports for investigators, administrators, funding agencies, and regulatory bodies.
• Support, plan and coordinate regular advisory board and steering committee meetings as required.
• Implement and maintain quality control processes throughout the clinical trials.
• Use project management fundamentals to facilitate the development of publications and presentations in close collaboration with research collaborators.
• Maintain a portfolio of conference presentations, publications, and white papers that illustrate the clinical benefits of PulseMedica's technologies.
• Perform miscellaneous job-related duties as assigned, providing support for other programs as needed.

Qualifications:

• Bachelor's degree in a scientific, health-related, or business administration program is preferred.
• Minimum of 5 years experience in the medical device industry.
• Minimum of one (1) end-to-end ownership and successful FDA approval of class III medical device.
• Minimum of two (2) end-to-end ownerships and successful FDA approval of class II medical devices.
• Self-motivated team player comfortable in a dynamic, fast-paced environment.
• Detail-oriented and meticulous in all aspects of work.
• Demonstrated strong follow-through skills, proactive problem-solving ability, and a proactive mindset.
• Familiarity with medical terminology, clinical medicine, clinical trials, and Good Clinical Practice concepts.
• Professional demeanor with robust communication skills suitable for interactions with the public, physicians, health care professionals and researchers.
• Ability to thrive both independently and in a collaborative team environment.
• Strong interpersonal, customer service, and multi-tasking skills are essential.
• Proficiency in the Microsoft Office suite.
• Flexibility, organization, attention to detail, and a tenacious follow-through approach.
• Ability to work effectively under pressure, multitask, and manage multiple deadlines.

Highly Desired Skills and Experience:

• Minimum of 3 years experience in ophthalmology related industry.
• Preferred candidates will be located in Edmonton
• Preferred candidates will have ten (10) or more years of experience as a clinical research professional at either a research site or sponsor/CRO.
• Proficiency in electronic health systems and databases used in research environments, or a willingness to learn and demonstrate proficiency.
• Knowledge of federal, state/province, and local regulations, including health data privacy policies and procedures.

Anticipated Start Date: As soon as a suitable candidate is found

Duration: Full time Permanent (40 hours per week)

Salary: Commensurate to experience and qualifications

Location: Edmonton (Hybrid)

What you can expect from PulseMedica:

• Competitive compensation, health, dental and vision benefits and the option to participate in our employee stock option plan
• Free on-site gym (Jackson's Gym)
• A role that contributes to helping change people's lives by enhancing their vision
• A unique opportunity to build, grow, and be part of a team that is going to revolutionize a multi-billion dollar industry
• Hybrid work
• Growth Opportunities
• Monthly team events
• Working for a company that was recently Great Place to Work certified

We believe that diverse teams perform better and that fostering an inclusive work environment is a key part of growing a successful team. We welcome people of diverse backgrounds, experiences, and perspectives to apply for this position.