Clinical Trial Manager
MedRhythms is a digital therapeutics company committed to revolutionizing healthcare for people living with neurologic disease and injury. Our mission is to help patients walk confidently again, by expanding access to patient-centered, world-class therapy.
Our groundbreaking technology uses sensors and immersive music to deliver evidence-based treatments to improve walking. At its core is a cutting-edge treatment mechanism based on the latest neuroscience research in music: rhythm can be used clinically to directly target the human motor system and improve functional outcomes in walking. It's our mission to see these outcomes realized for the millions of people worldwide who struggle with walking impairments.
MedRhythms has a pipeline of innovative therapies in neurology, including Stroke, Parkinson’s Disease, and Multiple Sclerosis. Our flagship product for chronic stroke received Breakthrough Device designation from the FDA, and we’ve launched clinical trials with leading research institutions across the U.S., including Johns Hopkins, Mount Sinai, Cleveland Clinic, and Spaulding Rehabilitation.
Cultural Pillars that drive us and our success:
We are committed to People First
We are committed to Excellence Always
We are committed to being Action Focused
We are building a workforce that consists of hybrid team members living and working in and around our Portland, Maine headquarters and remote individuals located in Massachusetts, New Hampshire, Vermont, New Jersey, New York, Pennsylvania, Florida, Illinois and California. We do ask all of our team members to visit our headquarters throughout the year to get to know our team and fully integrate with our culture! If you are located in an area that is not listed, don't let that stop you from applying. We would still be interested in speaking with you!
Under the supervision of the Head of Clinical Trials, the Clinical Trial Manager (CTM) is responsible for providing managerial oversight for multicenter trials including strategic planning; protocol development; site activation; data management; regulatory processing; and auditing/monitoring. Ensures that project milestones are delivered on time, within budget and are of high quality. The candidate will be familiar with and ensure that all clinical trials remain in compliance with the Federal Code of Regulations and ICH Guidance on Good Clinical (Research) Practice. The candidate will work with the Head of Clinical Trials to develop standard operating procedures and metrics to monitor performance. Identifies and anticipates obstacles to be overcome and proposes solutions. Recognizes opportunities for continued improvement and operational efficiencies. Acts as liaison between study sites; vendors; MedRhythms’ Department of Clinical Trials; and other stakeholders. Maintains positive relationships in representing the company and project reputation with collaborating investigators, government agencies, private industry and other external organizations. The candidate will also support the research team with additional duties as assigned by the Head of Clinical Trials.
Compensation will be commensurate with experience and is a combination of salary and bonus potential.
- Overall responsibility of assigned clinical trials from start-up to close-out
- Assists in site identification and activation; coordinate site management activities
- Assists with negotiation and execution of clinical trial agreements
- Participates in protocol development, CRF design, and clinical trial report writing
- Oversees study site regulatory documentation
- Oversees patient recruitment and assists sites with retention strategies
- Assists with setting targets for clinical monitoring staff, as applicable, and ensure the recording of trials in compliance with project goals
- Creates and implements study-specific clinical monitoring tools and documents
- Creates and provides project-specific training to sites, CROs, etc.
- Arranges and oversees site visits
- Assures compliance with SOPs, federal, state, and local regulations, and CFR, ICH, and GCP guidelines
- Tracks study material inventory and supplies
- Assists in the management of clinical trial vendors (CROs, EDC, eTMF, commercial IRB, etc.)
- Fosters relations that will ensure excellent working relationships with study sites and vendors
- Distinguishes between critical and noncritical priorities, creating, managing, measuring and reporting project timelines for milestone deliverables; at times, this may require negotiating timelines with cross functional or external stakeholders
- Proactively identifies/manages study risks and develops contingency plans for potential problems or obstacles with key internal/external stakeholders to deliver on deadlines and scope commitments.
We’re looking for you to bring
- Bachelor's degree in biological sciences, health sciences, public health or closely related field.
- Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
- 3+ years of clinical trial research experience with 2 years of experience managing multicenter trials
- Significant demonstrated experience in writing protocols, SOPs, templates, and trial reports
- Demonstrated planning experience setting project timelines and priorities, identifying and acquiring needed items or support to complete projects, organization of all materials, and the creation of control systems such as reports and feedback loops that identify areas for improvement and to control for unforeseen problems
- Demonstrated ability to effectively manage multiple priorities, prioritize multiple projects and meet the demands of a fast-paced and dynamic work environment.
- Adaptable to quickly changing priorities.
- Demonstrates strong problem-solving and analytical skills.
- Creatively addresses complex or new problems.
- Excellent interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship.
- Works well with others to achieve common goals.
- Ability to cultivate relationships with multiple stakeholders at various levels of administration.
- Strong communicator; includes verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator. Ability to influence and negotiate.
- Skills to work collaboratively with other cross-functional teams. Ability to interface and collaborate with other members of an extended team. Proven ability to effectively coordinate with others in organization.
- Strong Knowledge of Code of Federal Regulations and Good Clinical Practices as it relates to clinical trials—Knowledge of federal, state and local research regulations and guidelines involving human subject research.
- Available to travel
What we can offer you
- Meaningful, purpose driven work on a life-changing product
- Collaborative, supportive, smart and fun team
- Competitive compensation and benefits: Medical, dental, vision, disability, stock options, bonus potential, paid parental leave
- Generous paid time off: Unlimited vacation, sick and volunteer time off
- Flexible hybrid work environment: Work where and when you are most productive
- Downtown Portland, Maine office: Inviting office in the heart of the Old Port