Senior Clinical Data Manager

Working Location: NATIONWIDE; Canada 

Workplace Flexibility: Remote

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Our five Core Values empower us to achieve Our Purpose: 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

Learn more about Life at Olympus: https://www.olympusamerica.com/careers.

Job Description

As part of the Medical and Scientific Affairs group, an integral delivery unit within the Global Clinical Affairs organization, the Senior Clinical Data Manager is accountable for driving timely and high-quality data management deliverables supporting the Olympus portfolio.

 

The Sr. Clinical Data Manager designs, develops, and maintains key data management deliverables used to collect, review, monitor, and ensure integrity of clinical data, oversees application of industry standards, data review and query management, and is accountable for quality study dataset release and consistency for submission data.

 

This position serves as a key liaison between clinical operations, biostatistics, and external vendor and is responsible for leading data management responsibilities for several concurrent clinical trials, utilizing the electronic data capture and management systems. This role manages trials in various stages, from planning, to start-up, conduct, closeout, and archiving. The role assists in the design and implementation of clinical data management processes with vendors, ensuring completeness, correctness, and consistency according to Siemens standards. This role collaborates with the Biostatistics and Clinical Operations team members, and other functions as applicable.

Job Duties

• Work collaboratively with other Data Managers, Programmers, Biostatisticians, Clinical Operations, Medical Directors, and Regulatory staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting.
• Focus on study-start up and database amendment implementation.
• Study level coordination and hands-on CDM tasks, including clinical data review and reconciliation.
• Authors data management plans (DMPs), case report forms (CRFs), edit check specifications (ECs), Data Review Guidelines (DRGs), Data Quality Plans (DQPs), and data validation rules.
• Manage database design, build, testing, and validation activities with internal teams or CROs/vendors.
• Oversee data cleaning activities including query generation/resolution, data reconciliation (e.g., SAE, lab, coding), and data reviews.
• Conduct ongoing risk-based data reviews to ensure data quality and identify trends or issues early.
• Collaborate with cross-functional teams (Clinical Ops, Safety, Biostatistics, Programming, Regulatory).
• Manage timelines and deliverables for database locks (interim and final), ensuring audit readiness.
• Coordinate with EDC and other data vendors (e.g., ePRO, IRT, central labs), ensuring seamless integration and data flow.
• Represent data management in study team meetings and regulatory audits or inspections.
• Ensure completeness, correctness and consistency of clinical data and data structure across projects.
• Ensure accurate tracking and reporting of study metrics and timelines.
• Proactively drives quality and efficiency to meet timelines and milestones for data management, ensuring scientific and operational excellence in support of strategic imperatives and in collaboration with he cross functional study team(s).
• Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements as applicable.
• Assist in the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM.
• Mentor and train junior data managers or contractors as needed.
• Other duties as assigned.

Job Qualifications

Required:

• BS degree in a Biomedical Science or comparable field of study.
• Bachelor’s degree with a minimum of 8 years of global clinical data management experience, or