Job Title: Clinical Trials Program Manager
Details: Full-Time, On-Site
Location: Ellicott City, Maryland and Washington, DC
Evon 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 priorities
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 Performance Indicators for the Company and individual projects. Provide expert project management with multiple simultaneous projects.
- Organize flow of study participants at study sites; ensure compliance with study visits and medications
through frequent contact with study participants
- Extract medical data from charts requiring interpretation
- Perform quality assurance/quality control on data collected during study visits and review source documents. Develop and implement procedures for quality management.
- Maintain regulatory files for the study in compliance with Sponsor/FDA/NIH/DoD/DSMB/IRB guidelines.
- Perform regular statistical analyses on all study-related data using SPSS or other statistical software
- Lead study meetings and provides updates on protocol implementation status and make recommendations on operational issues.
- Oversee and track budget expenditures for study operations.
- Anticipate and prevent problems with sites or collaborators that may affect KPIs. Co-ordinate activities and information flow between collaborators, contractors, and other R&D stakeholders
- Assist with writing and editing NIH grants, scientific publications, research manuscripts, and IRB and IBC protocols for approval by medical school committees
- Prepare and present weekly & monthly project progress analysis and reports
- Prepare biannual project progress reports for NIH and other program/grant sponsors
- Perform other duties as assigned by management
Required Skills and Experience:
- Bachelor’s degree in clinical field or health sciences. Post-graduate degree preferred
- Minimum 5-year experience in project management roles, preferably in clinical trials
- Advanced data management and analytics
- Excellent attention to detail
- Excellent leadership and interpersonal skills
- Excellent written and verbal communication skills
- Strong knowledge of healthcare, regulatory, and government funding opportunities
- Proven leadership experience with P&L responsibility
- Experience working with REDCap and VivaVault
- Must be able to interact effectively with study participants from diverse backgrounds
- Self-motivated, innovative, and competitive attitude to work
- Travel – up to 10% regional
If you believe you have a strong candidacy for this role, kindly send your resume and cover letter to firstname.lastname@example.org with the subject line “Clinical Trials Program Manager.” Also indicate your earliest start date, if considered for the role.