Clinical Studies Manager Jobs

The Clinical Studies Manager is responsible for overseeing and managing clinical studies and clinical operations of the company. The Clinical Studies Manager will work closely with data scientists and engineers at DeepHealth to execute clinical studies as well as oversee pre- and post- market activities of our medical devices. The position will be part of the larger clinical team and will provide periodic status reports of all clinical activities to the Director of Clinical Studies.

Responsibilities:

• Creating and managing clinical SOPs
• Managing the execution of clinical studies including creating project plans and documentation such as study protocols, data management plan, analysis plan, project deliverables, timelines, and stakeholder management.
• Operational execution of pre- and post-market surveillance activities
• Managing Clinical Research Organizations to conduct clinical studies
• Providing periodic status reports of ongoing clinical activities
• Management of IRB documentation and communication
• Contributing to defining appropriate quality metrics of the medical device portfolio and managing the process of data collection
• Periodic internal and external communication regarding clinical research

Requirements:

• Excellent oral and written communications skills
• Knowledge in clinical data statistics
• Strong scientific reasoning and clinical validation skills
• Experience working with real-world healthcare data
• Bachelor’s degree with at least 5 years of experience in project management or Master’s degree in health-related field

Quality Standards

• Communicates, cooperates, and consistently functions professionally and harmoniously with all levels of supervision, co-workers, patients, visitors, and vendors.
• Follows OSHA regulations, RadNet and site protocols, policies and procedures.
• Demonstrates initiative, personal awareness, professionalism and integrity, and exercise confidentiality in all areas of performance.
• Promotes good public relations on the phone and in person.
• Completes job responsibilities in a quality and timely manner.
• Follows all local, state and federal laws concerning employment to include but not limited to: I-9, Harassment, EEOC, Civil rights and ADA.
• Follows HIPAA, compliance, privacy, safety and confidentiality standards at all times.
• Reports to work regularly as scheduled; consistently punctual with respect to working hours and lunch schedules, and maintains satisfactory personal attendance in accordance with RadNet guidelines.
• Practices universal safety precautions.
• Consistently adheres to the time management policies and procedures.
• Adapts and is willing to learn new tasks, methods, and systems.

Working Environment

Remote setting