Clinical Trials Program Manager

Join to apply for the Clinical Trials Program Manager (Full-Time) role at Evon Medics, LLC

Join to apply for the Clinical Trials Program Manager (Full-Time) role at Evon Medics, LLC

Job Title:
Clinical Trials Program Manager

Details:
Full-Time, On-Site

Location:
Ellicott City, Maryland and Washington, DCEvon Medics, LLC is a medical device and neuroscience research company that develops innovative devices and therapeutics set to disrupt the healthcare industry. We are leading the development of Disease Modifying Therapies (DMT) for Alzheimer’s Disease, Opioid Use Disorder, Traumatic Brain Injury, Chronic Pain, and other neurological diseases that have remained elusive to treatment. Our breakthrough products have the potential to reap first-to-market benefits for a DMT in the markets we compete, and we are laser-focused on the commercialization and distribution of our products to help alleviate the sufferings of billions of patients all over the world.

Evon Medics, LLC is actively seeking a Clinical Trials Program Manager to join our innovative organization. The ideal candidate will manage and train Research Program Coordinators and Associates to implement pre-award and post-award grant activities, including study design, execution, analysis, and evaluation. We need self-driven individuals with the ability to develop and implement interventional and observational studies within clinical and community settings.

The ideal candidate must also be able to “zoom in” to matters of regulatory compliance and operations and “zoom out” to matters of broader programmatic leadership and problem-solving. This role is both strategic and facilitative, requiring a forward-thinking individual with strong interpersonal skills, scientific acuity, analytic skills, and the capability to adeptly shift between prioritiesJob Summary:The Clinical Trials Program Manager (CTPM) will own the entire clinical trial processes from study design to regulatory approval and will be provided all necessary tools for success.

CTPM will be available on site to provide hands-on support and supervision of all Clinical Trials and Research staff and provide regular feedback and training/refresher training sessions. CTPM will also drive recruitment, enrollment, and retention of study participants in all Clinical Trials to ensure study success. The Clinical Trials Program Manager will report to the Director of Clinical Trials and Research Administration.

Essential Duties and Responsibilities :

• Develop and execute winning strategies for recruitment, enrollment, and retention of study participants across all clinical trials to ensure successful completion of the clinical trials
• Lead scientific implementation and daily operation of research studies, monitoring protocol compliance and ensuring data quality and adherence to all relevant regulatory requirements
• Co-ordinate and manage all R&D activities, projects, and clinical trials to assure validity of findings
• Provide direct supervisory support to all research members of staff
• Develop research protocols and associated procedures to achieve specific research aims
• Ensure adherence to protocols and oversee record management for research studies
• Source for grants and prepare grant applications and ongoing progress reports
• Assist with budget development and award preparation and submission for prime awards and subawards
• Develop tools for study implementation including data collection tools such as REDCap, standardized order sheets, study reference materials, and patient questionnaires. Evaluate these tools on an ongoing basis for validity.
• Prepare and submit all study related updates, changes to research, required reports, and study related instruments to IRB, FDA, and other relevant regulatory authorities
• Maintain regular communication with IRB to ensure efficient review of study documents throughout life span of each protocol
• Oversee all study recruitment procedures consistent with IRB approved methods
• Creatively identify stakeholders and engage communities in clinical trials and product development
• Develop and maintain Key…