Clinical Trial Data Specialist

About the Opportunity:

This team is a full-service CRO supporting innovators and entrepreneurs bringing In Vitro Diagnostics (IVD) and Medical Devices to market. The Clinical Trial Data Specialist manages data-related activities in clinical trials, ensuring high-quality data collection, integration, and analysis throughout the trial lifecycle. This role supports data management and analytical functions while ensuring compliance with regulatory requirements, trial protocols, and Good Clinical Practice (GCP) standards. The specialist collaborates closely with the Senior Data Manager and Clinical Operations team to maintain accurate, clean, and analysis-ready trial data.

Responsibilities:

• Collaborate with Senior Data Manager to manage clinical trial data collection, cleaning, and validation
• Design, implement, and maintain data collection systems (e.g., electronic data capture) with the data management team
• Ensure data entry into EDC systems complies with protocol and regulatory guidelines
• Track queries and data discrepancies; support their resolution
• Verify accuracy and completeness of trial data before database lock
• Perform preliminary data analysis for interim or final clinical trial reporting
• Assist in creating clinical trial reports including tables, listings, and figures
• Conduct exploratory analysis to support clinical decisions
• Ensure compliance with ICH-GCP, FDA regulations, and other applicable guidelines
• Develop and review data management documentation such as Data Management Plans, Data Validation Plans, and Case Report Forms with Senior Data Manager
• Provide regular updates on data status, issues, and progress to project teams
• Communicate with clinical operations to assess data quality and resolve data issues
• Troubleshoot and provide technical support for data-related problems during trials
• Identify data-related risks proactively and work with stakeholders to mitigate them
• Document and track data discrepancies or issues properly

Requirements:

• Bachelor’s degree in Life Sciences, Health Sciences, Statistics, Computer Science, or related field
• Minimum 2 years of experience in clinical data management, clinical trial data analysis, or related roles in pharmaceutical, biotechnology, or CRO industry
• Hands-on experience with EDC systems (e.g., MedNet, Medidata, Veeva Vault), data validation tools, and statistical software (e.g., Python, JMP, SAS, R)
• Familiarity with clinical trial design and regulatory requirements (FDA, EMA, ICH-GCP)
• Experience with data visualization tools such as Power BI
• Strong analytical and problem-solving skills
• Excellent verbal and written communication skills
• Ability to collaborate effectively with cross-functional teams and stakeholders
• Strong attention to detail and ability to meet tight deadlines
• CDISC or equivalent certifications are a plus

Benefits & Perks:

• Medical, Dental, and Vision Insurance
• Health Reimbursement Account (HRA)
• Flexible Spending (FSA) / Dependent Care Accounts (DCA)
• Short and Long-Term Disability
• Group Term Life Insurance
• 401(k) with Safe Harbor Match
• Unlimited PTO
• 13 Paid Holidays

Compensation:

• Base salary range $70k - $75k
• Employee Stock Options

Key skills/competency:

• Clinical Data Management
• EDC Systems
• Data Validation
• Statistical Software
• ICH-GCP
• FDA Regulations
• Data Visualization
• Analytical Skills
• Problem Solving
• Cross-functional Collaboration