Clinical Data Manager II

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

The Clinical Data Manager II is an experienced professional with extensive knowledge on end-to-end data management activities in various clinical studies and phases. The Clinical Data Manager II independently acts as the data management representative on assigned clinical trials. He/she is responsible for designing, developing, validating, implementing, and maintaining databases used for clinical trials of in vitro diagnostic (IVD) assays. He/she has expertise with the overall data processes such as data review, data clean up, and data quality analysis.

The Clinical Data Manager II is a creative problem solver and critical thinker with a proven track record in overseeing Clinical Data Management and must possess strong communication skills and experience working effectively with cross-functional teams. He/she is highly organized who can multitask and adjust direction based on changing project/corporate priorities.

Independently act as the data management representative on assigned clinical trials.
• Manage the day-to-day activities of the data management with Clinical Research Associate for clinical trial data including the subject safety/confidentiality data and the critical efficacy endpoints.
• Configuration and hands-on working knowledge of Electronic Data Capture (EDC) systems, g., Medrio
• Manage the definition of Case Report Form (CRF) requirements.

• Owning the development of Clinical Data Management technology and process Quality SOPs, templates and tools.
• Mentor and assist with the onboarding of the Clinical Data Managers, if needed
• Ensure all Data Management procedures are executed with a high attention to detail and
• Works in conjunction with Clinical Operations, Research and Development, and other operational departments to ensure accurate, efficient, and complete data collection.
• Interact with Clinical Research Associates and study sites regarding generation and reconciliation of queries to meet study timelines.
• Serves as a liaison between Clinical Project Managers and Biostatisticians
• Assist in EDC system selection and
• Support submissions
• Efficient under tight timelines and strict deliverables with demonstrated ability to resolve issues and meet deadlines.
• In-depth knowledge of Data Management Practices and other regulatory guideline specific to data management such as ICHGCP, ISO 14155 - Clinical investigation of medical devices for human subjects, and STARD guidelines.

• Bachelor's Degree required with 5+ years of relevant work experience in Clinical Data Management position
• Experience working in Pharmaceutical/ Medical Device/ Biotechnology/ CRO industry in Clinical Data Management is required

Preferred Competencies:

• Strong presentation skills to internal cross functional teams and external collaborators
• May be required to work additional hours outside of the normal work shift to ensure business commitments are met (evenings and weekends).
• Be an initiative-taker, detail oriented, organized, and able to prioritize and balance workloads to meet strict critical deadlines along with performing under pressure in a fast- paced environment.
• Ability to manage, prioritize, and routinely report progress on multiple projects to cross functional teams and Clinical Management
• Demonstrated knowledge of applicable S. regulatory requirements for conducting clinical trials
• Fluent French and English

Required International Travel (Canada) - 10%

*All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. (USA Only)*