Clinical Data Manager

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At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.

Main Purpose of the Role

The Clinical Data Manager provides expert Data Management (DM) support and project management for DM activities for multiple clinical trials executed by Bioventus. The Clinical Data Manager will be responsible for activities pertaining to end-to-end data management of clinical trials including but not limited to; data management tool and system development, query management, supporting database set up activities, supporting data validation process’, supporting in-stream data review activities, performing thorough user acceptance testing of applicable databases, supporting database lock preparations, and providing periodic and ad hoc reports of new and ongoing study data/study progress as needed.

Key Responsibilities

• Actively participate in the entire life cycle of clinical trial data management. Interact and collaborate with project managers and team members to support the set-up, maintenance, and close out of the data management aspects of global clinical trials to ensure high data quality.
• With support, manage data management activities for assigned clinical trials such as Electronic Case Report Form (eCRF) development, database set-up activities, data validation process, SAE reconciliation), training of study site personnel in Case Report Form (CRF) completion, and data clarification processes as appropriate.
• Ensure the design of the eCRF is consistent with the study protocol, meets clinical requirements, and promotes accurate and efficient data collection.
• Create and review data validation check specifications. Coordinate relevant parties in the development and testing of eCRF and data validation checks.
• Perform thorough user acceptance testing (UAT) on eCRF and data validation checks.
• Perform meticulous data management tasks, including proactively identifying data issues and periodically communicating with study sites, to ensure high quality clinical data.
• Provide periodic and ad hoc reports of study data and study progress as well as process data discrepancies.
• Lead data management data review activities (cleaning activities including listing review, external data reconciliation and data review) and any other clinical study team data reviews required, in so ensuring completion of all activities leading to the study database lock.
• Assist with the development and maintenance of data management documents, SOPs, and guidelines.
• Holds oneself and others accountable to conduct business in a manner compliant with Bioventus’ Code of Compliance and Ethics, policies and procedures and internal controls applicable to their role.
• Other duties as assigned

Education And Experience (Knowledge, Skills & Abilities)

• 4-year degree in Information Systems, Statistics, or related science/health field OR equivalent combination of education and experience
• 3 years’ experience developing programming scripts using a broad variety of language/tools
• Demonstrated knowledge of Good Clinical Data Management practices within the current FDA guidelines
• Detail oriented with strong organization skills and ability to execute effectively with multiple competing priorities
• Proven ability to support and build collaborative relationships both internally and externally
• Extensive experience with a variety of EDC systems, including but not limite to VieDoc, SmartTrian, and Medrio preferred
• Experience in Med Tech/ Med Device studies preferred
• Knowledge of EU MDR requirements preferred
• JavaScript and/or R programming expertise preferred

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Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms of diversity and take pride in working with top talent from every walk of life. In the spirit of inclusivity, qualified applicants will be considered without regard to age, ethnicity, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion or sexual orientation.  All individuals, regardless of personal characteristics, are encouraged to apply.