Clinical Operations Manager

3 weeks ago


Newton, United States BioSensics Full time

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 trialprojects. The Clinical Operations Manager is themain 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 compliancewithwearing 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

by Jobble

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