Clinical Study Database Designer

Additional Location(s): US-MN-Arden Hills; US-MN-Mankato/Rochester; US-MN-Maple Grove; US-MN-Minneapolis; US-MN-Minnetonka; US-MN-Northern/Duluth; US-MN-Plymouth

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.                

About the role:
A Clinical Study Database Designer is responsible for ensuring the quality and integrity of clinical data via the creation of tools such as data collection instruments, data management plans, database specifications, and edit checks, as well as the review of clinical data for completeness, accuracy, and consistency. This is achieved through collaboration with clinical colleagues (e.g., Project Management, Trial Operations, Site Operations, Clinical IT, Global Safety, Biostatistics, Quality and Medical Sciences) and other cross-functional team members (e.g., Legal and Regulatory). You will primarily be focused on electronic Case Reports Forms (eCRFs) design, configuration, and validation. This is the role in charge of the creation and the updates of the associated clinical database where the study data will be captured, reviewed, and stored.

 

This is a hybrid position (in the office minimum for three days per week) with the flexibility to be located in Arden Hills or Maple Grove, MN. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist. 

Your responsibilities will include:

• Define, maintain and communicate high-level project planning based on the clinical study timelines and the priorities defined by management.
• Review clinical protocols, identify data requirements and provide feedback to the owner in order to streamline data capture and to mitigate the related risks if any. 
• Collaborate actively with the study team to clarify study-specific needs, assess various design options based on cost and feasibility in order to define the best solution.
• Create or update the study-specific eCRFs in the approved data capture system (Medidata Rave), including complex edit checks to verify the data completeness, accuracy and consistency in accordance with the investigational plan.
• Ensure complete peer review of the technical design including forms, fields, matrices, edit checks and derivations.
• Leverage standard forms, design patterns and naming conventions to guarantee consistency across studies.
• Define and execute data entry scenarios or test scripts to ensure a complete and comprehensive validation of the eCRFs.
• Identify payment rules based on study budget in collaboration with the Payment Specialist and the Clinical Trial Manager. Configure the associated compensation forms implementing all the required triggers.
• Partner with technology teams to ensure the required systems and reports are developed and released on time to meet the study requirements.
• Organize and facilitate regular interactive review meetings with the study team and formal User Acceptance Testing.
• Develop and maintain functional documentation and guidelines in accordance with Good Clinical Practices (GCP) and Good Documentation Practices (GDP).

 
Required qualifications:

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

Preferred qualifications:

• Ability to work in fast-paced environment requiring support of 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 a strong attention to detail
• Solid understanding of clinical area and industry practices, techniques and standards
   

Requisition ID: 593927

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for o