Clinical Study Manager
Remote
Full Time
Manager/Supervisor
Duties & Responsibilities
- Study Planning and Coordination: Develop study protocols, budgets, and timelines; coordinate with cross-functional teams to ensure successful trial execution.
- Regulatory Compliance: Ensure adherence to FDA regulations, Good Clinical Practice (GCP), ISO 14155, and other applicable guidelines.
- Site Management: Manage clinical trial sites, including startup activities, training, and ongoing performance monitoring to ensure compliance and data integrity.
- Data Management: Oversee accurate data collection, ensure data quality, and collaborate closely with data management teams.
- Risk Management: Identify potential study risks and implement proactive mitigation strategies.
- Serve as the primary clinical expert for advanced user support, including clinicians and patients, on the IpsiHand system.
- Demonstrate strong leadership and communication skills with the ability to guide cross-functional teams.
- Thrive in a fast-paced, evolving research environment, adapting quickly to shifting priorities and challenges.
Required Work Experience
- 3-5 years minimum experience in the medical device industry such as Contract Research Organization (CRO) or other clinical trials environment; e.g., hands on regulatory, clinical operations (in-house CRA or study coordinator), and site monitoring experience
- Strong preference for Licensed Doctorate of Occupational Therapy with 5+ years of experience in neurorehabilitation - post-stroke care, research or equivalent in experience. Experience working with innovative rehabilitation technology is highly preferred. Ability to fill in for OTs and perform study assessments desired.
- Willingness to travel up to 15% as needed.
Preferred Work Experience
- Clinical research experience in post-stroke rehabilitation
- Strong background in stroke, upper extremity therapy, neuroplasticity principles, and motor recovery.
- Familiarity with clinical outcome measures (e.g., Fugl-Meyer, ARAT, Box & Blocks, etc.).
- Ability to conduct patient evaluations, including baseline assessments (e.g., Fugl-Meyer) and suitability for BCI therapy.
- Deliver comprehensive training to therapists, clinicians, and caregivers on IpsiHand therapy, both virtually and in person.
Other skill requirements
- Proficient in delivering clinical support virtually—comfortable using Zoom, Teams, and telehealth platforms for patient and clinician interactions.
- Able to build rapport and provide empathetic care through digital communication.
- Exceptional interpersonal skills and comfort presenting and teaching in clinical settings.
- Clear and professional communicator in both verbal and written formats.
- Confident delivering clinical training sessions to therapists and caregivers in 1:1 or group settings.
- Able to coach for behavior change and adherence with patients using motivational strategies.
- Able to effectively collaborate with engineering, product, research, and sales teams, providing clinical insight to inform device related improvements.
Please note that the salary information is a general guideline only. Neurolutions considers factors such as the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, and internal equity, as well as location, market, and business considerations when extending an offer.
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