Clinical Database Manager (Remote/Flexible) Acton, Massachusetts

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

Job Title:                       Clinical Database Manager

Department:                  Clinical and Medical Affairs

FLSA Status:                Exempt

Position Overview:

The Clinical Database Manager requires in depth knowledge and experience in clinical data and systems management with demonstrated capabilities in database design and validation, and coordinating data management activities across multiple studies. The Clinical Database Manager will also contribute to data management process improvements and initiatives within the department and all aspects of the clinical data management lifecycle.

Responsibilities:

• Provide data management expertise and support clinical colleagues using data management best practices.
• Understand the device data collected as part of clinical studies (pre and post market) and manage the data ensuring compliance with protocol, regulatory, GDPR and HIPAA.
• Create and/or review study-specific Case Report Forms (CRFs) using device study knowledge and protocol specific information in collaboration with clinical team.
• As applicable, develop Case Report Form Library of common forms that can be used consistently across studies.
• Develop, configure and validate electronic data capture (EDC) databases, and coordinate User Acceptance Testing (UAT).
• Develop and/or review study-specific data management and database documentation, which may include Data Management Plan (DMP), CRF Completion Guidelines (CCGs), Annotated CRFs, Edit/Logic Check Specifications, and UAT Plans.
• Collaborate with clinical team members to generate data review guidelines and perform data review and query generation/closure.
• Prepare data for scheduled snapshots/database locks.
• Perform appropriate database maintenance and closure and archival activities upon study completion.
• Develop and provide study tracking and metrics tools to improve monitoring of study progress and ensure data quality.
• Collaborate with clinical colleagues to train Investigators and Coordinators on the EDC system, and CRF completion guidelines as needed.
• Support improvements related to Clinical processes and data management activities and support the development of new processes.
• Monitor data quality and accuracy and ensure compliance with company policies and procedures and all regulatory requirements.
• Lead database development projects involving both internal and external resources.

Education and Experience

• Bachelor’s degree is required at minimum
• Requires 7+ years of clinical data and systems experience
• Strong computer skills with a proficiency with MS Windows based applications
• Working knowledge of both US and OUS regulations related to the conduct of clinical studies and managing clinical data, developing databases and managing protected health information including, but not limited to, Good Clinical Practices (GCP), ISO and FDA regulations including 21 CFR part 11

Preferred Skills and Competencies:

• Able to prioritize workload, assign realistic completion dates, and complete assignments on schedule
• Excellent written and oral communications skills required
• Comfortable with multiple Electronic Data Capture (EDC) Systems
• Strong organizational skills and attention to detail.
• Ability to work independently and manage multiple tasks in a fast-paced, changing environment.

Travel Requirements:

• This position requires some travel up to 5% of the time.

NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired). ## LI-Remote 

Additional Information:

The US base salary range for this full-time position is $109,400.00 - $164,300.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.