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**

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical data managementEDC programmingdata validationdata cleaninguser acceptance testingstatistical analysisproject managementdata reconciliationquery generationdata review

Soft Skills

communication skillsattention to detailwriting compositionproofreadingeditingethical standardstrustrespectintegritycontinuous improvement