Clinical Data Manager
About The Position
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.
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.
- 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.
Nice To Haves
- Certified Clinical Data Manager (CCDM) Certification preferred but not required.
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
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
- Work-life integrated culture that supports an employee centric mindset
- Offers onsite, hybrid and field work environments
- Paid volunteering and charitable donation/match programs
- Employee Resource Groups
- Dedicated Training Resources and Learning & Development Programs
- Paid Educational Assistance
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
