Clinical Data Manager (Multiple Openings)

NSF • Germantown, MD

16h • $115,939 • Hybrid

About The Position

Design, develop, and manage Electronic Data Capture (EDC) systems and electronic Case Report Forms (eCRFs) for clinical studies. Develop and implement data validation checks to ensure data integrity, accuracy, and completeness. Identify, investigate, and resolve data discrepancies in collaboration with clinical, biostatistics, and programming teams. Conduct database lock activities, including reconciliation, cleaning, and final data review. Ensure compliance with regulatory requirements (FDA, ICH-GCP) and company Standard Operating Procedures (SOPs). Collaborate with cross-functional teams, including biostatisticians, clinical operations, and project managers, to support clinical trial data management activities. Provide data management input in study protocols, case report forms, and study plans. Generate reports, listings, and summaries to track data status and quality.

Requirements

• Education: Bachelor’s – Statistics, Data Science or Life Science or a related field of study; Will accept equivalent of foreign degree.
• Experience: (2) years of experience in the position above or in a related role.
• Experience and/or Education must include: 1. Mathematical Statistics; 2. Applied Multivariate Analysis; 3. Categorical Data Analysis
• Will accept equivalent foreign degree; will accept a Master’s degree in above major fields of study in lieu of work experience; will also accept any fully equivalent combination of education, training, and/or experience.

Responsibilities

• Design, develop, and manage Electronic Data Capture (EDC) systems and electronic Case Report Forms (eCRFs) for clinical studies.
• Develop and implement data validation checks to ensure data integrity, accuracy, and completeness.
• Identify, investigate, and resolve data discrepancies in collaboration with clinical, biostatistics, and programming teams.
• Conduct database lock activities, including reconciliation, cleaning, and final data review.
• Ensure compliance with regulatory requirements (FDA, ICH-GCP) and company Standard Operating Procedures (SOPs).
• Collaborate with cross-functional teams, including biostatisticians, clinical operations, and project managers, to support clinical trial data management activities.
• Provide data management input in study protocols, case report forms, and study plans.
• Generate reports, listings, and summaries to track data status and quality.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level