Clinical Study Database Designer

Boston Scientific - Arden Hills, MN

Full-time - Mid Level

Hybrid - Arden Hills, MN

1,001-5,000 employees

Miscellaneous Manufacturing

About the position

The Clinical Study Database Designer is responsible for ensuring the quality and integrity of clinical data through the creation of data collection instruments, management plans, database specifications, and edit checks. This role involves collaboration with various clinical and cross-functional teams to design, configure, and validate electronic Case Report Forms (eCRFs) and manage the associated clinical database. The position is hybrid, requiring a minimum of three days in the office, with flexibility in location.

Responsibilities

• Define, maintain and communicate high-level project planning based on clinical study timelines and management priorities.
• Review clinical protocols, identify data requirements, and provide feedback to streamline data capture and mitigate risks.
• Collaborate with the study team to clarify study-specific needs and assess design options based on cost and feasibility.
• Create or update study-specific eCRFs in Medidata Rave, including complex edit checks for data verification.
• Ensure complete peer review of technical designs including forms, fields, matrices, and edit checks.
• Leverage standard forms and design patterns to ensure consistency across studies.
• Define and execute data entry scenarios or test scripts for eCRF validation.
• Identify payment rules based on study budget in collaboration with the Payment Specialist and Clinical Trial Manager.
• Partner with technology teams to ensure timely development and release of required systems and reports.
• Organize and facilitate regular review meetings and formal User Acceptance Testing.
• Develop and maintain functional documentation and guidelines in accordance with GCP and GDP.

Requirements

• Minimum Bachelor's degree or equivalent.
• Minimum 2 years of Clinical Database (eCRF) Design experience in the pharmaceutical or medical device industry.
• Medidata Rave EDC Certified Study Builder.
• Excellent interpersonal, verbal, and written communication skills.

Nice-to-haves

• Ability to work in a fast-paced environment supporting multiple projects and customers simultaneously.
• High customer focus and ability to collaborate closely with global and cross-divisional partners.
• Skilled in organization and prioritization with strong attention to detail.
• Solid understanding of clinical area and industry practices, techniques, and standards.

Benefits

• Access to the latest tools, information, and training for career advancement.
• Support for progressing in your career based on individual ambitions.