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Clinical Operations Manager

4 months 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 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