Job Details
Description
BioSensics is a biomedical engineering firm specializing in wearable medical sensor and telehealth technologies. Our physiological monitoring, telehealth, and biofeedback products are used in elderly care, physical therapy, rehabilitation, orthopedics, neurology, and many other areas.
We are looking for a self-driven, detail oriented and motivated individual to join our fast-growing team. To be successful in the role of Clinical Operations Manager, the individual will independently manage all operational aspects of our clinical trial projects. The Clinical Operations Manager is the main point of contact for study sponsor and will manage project timelines and ensure BioSensics deliverables are met for assigned projects. This includes:
Coordinating with our clinical partners and responding to client and subject inquiries
Develop working knowledge of BioSensics products
Provide customer support to clinical sites and study participants
Delivering, recovering, and tracking devices, managing device inventory for projects
Work closely with Engineering and Research Scientists to ensure customized BioSensics solution requirements are met and data reports are delivered on time
Regular phone and email outreach to study subjects or clinical sites related to subject compliance with wearing sensors and completing study questionnaires and assessments
Conduct training on BioSensics products and represent BioSensics at Investigator Meetings
Documentation of processes and process changes related to clinical projects. Strict adherence to established processes. Focus on continually improving processes for efficiency and accuracy
Work closely with Quality and support Quality System Manager in creating and maintaining requirements documentation, processes and procedures, and project-specific documentation
Ensure data for study is received and offloaded per procedure
Assist as needed with operations, office management and administration
Role: Operations
Desired Skills and Experience
Minimum 3-year clinical trial experience
Highly organized and detail oriented
Experience with handling PHI and familiarity with HIPAA regulations
Able to handle multiple competing priorities and manage multiple tasks
Prior experience interacting with clinical subjects a plus
Able to work independently as well as with a team
Strong interpersonal, communication (verbal and written)
BS or MS Degree in science, engineering, or technical discipline