Clinical Data Manager

Working Location: NATIONWIDE 

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 Clinical Data Manager (CDM) is responsible for supporting the planning, implementation, and oversight of data management activities for clinical studies in compliance with applicable regulatory requirements and company SOPs. This role will work cross-functionally with Clinical Operations, Biostatistics, Regulatory Affairs, Safety, and external vendors to ensure high-quality, reliable, and inspection-ready clinical data.

 

The ideal candidate has hands-on experience in electronic data capture (EDC) systems, query management, and study-level data review, and thrives in a collaborative, fast-paced medical device environment.

Job Duties

• Contribute to the development and review of CRFs, data management plans (DMPs), and data validation specifications
• Support database build activities and perform user acceptance testing (UAT)
• Manage ongoing data cleaning activities, including query generation, tracking, and resolution
• Perform data review to ensure accuracy, consistency, and completeness
• Reconcile clinical data with external data sources (e.g., safety, imaging, core labs, device data)
• Support interim data reviews and database freezes/locks
• Track and report data management metrics (e.g., query aging, data entry timeliness, reconciliation status)
• Participate in cross-functional study team meetings
• Ensure data management activities comply with GCP, ISO 14155 (if applicable), and company SOPs
• Contribute to inspection readiness and support audits as needed

Job Qualifications

Required:

• Bachelors level degree or equivalent in health/science related field required.
• Minimum of 2-5 years of experience in clinical data management.
• Knowledge of clinical trial design and analysis issues.
• Proficiency with EDC programming and management (Medidata EDC, Simplified EDC).
• Familiarity with statistical analysis programs (R or SAS). Familiarity with Salesforce maintenance and programming.
• Familiarity with Salesforce maintenance.
• Knowledge of medical terminology.
• Knowledge of FDA regulations regarding data quality HIPAA and clinical trials conduct.
• Proven abilities in project management resource planning.
• Strong verbal and written communication skills.
• Superior writing composition English grammar skills a must including proofreading editing and strong attention to detail.
• Works precisely according to procedures rules and regulations has a passion for continuous improvement and quality.
• Demonstrates the highest ethical standards actively promotes trust respect and integrity in all dealings both inside and outside the Company.
• Other projects and duties as necessary and assigned. Ability to work overtime is required.

 

Preferred:

• Certified Clinical Data Manager (CCDM) Certification preferred but not required.

Why join Olympus?

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

 

Equitable Offerings you can count on:

• Competitive salaries, annual bonus and 401(k)* with company match

• Comprehensive medical, dental, vision coverage effective on start date

• 24/7 Employee Assistance Program

• Free live and on-demand Wellbeing Programs