Clinical Data Manager
Posted 48ds ago
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Job Description
Clinical Data Manager supporting the planning and oversight of clinical data management activities at Olympus. Collaborating cross-functionally in a fast-paced medical device environment.
Responsibilities:
- 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
Requirements:
- 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.
- 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.
Benefits:
- 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
- Generous Paid Vacation and Sick Time
- Paid Parental Leave and Adoption Assistance*
- 12 Paid Holidays
- On-Site Child Daycare, Café, Fitness Center**













