Clinical Data Team Lead - Drive Global Trials

United States Digital Space LLC; United States; Remote; USD 110,000 - 170,000; Full time

Job summary

Unknown CRO is seeking a Data Team Lead with at least five years of data management experience in clinical trials. You will oversee CRF tracking, data entry, data validation, and data quality across EDC systems, while leading small DM project teams for clients.

You will develop study metrics, guidelines, and data processes, and contribute to training and UAT activities to ensure regulatory compliance and data integrity.

Qualifications

• College graduate in scientific, medical, clinical discipline or related field.
• Minimum of 5 years’ experience in Data Team Lead or similar field.
• Familiarity with ICH, 21 CFR Part 11, FDA and GCP requirements.
• Hands-on experience with clinical trial data and pharma development preferred.
• Strong problem-solving and communication skills.

Responsibilities

• Proficient with MS Office applications.
• Understand ICH, 21CFR Part 11, ISO 9001 and ISO 7001.
• Develop eCRFs, CRF Completion Guidelines, Edit check specs, and DMP.
• Create study tracking and metric reports for study team.
• Oversee CRF tracking, data entry, data integration, validation, and QC audits.
• Perform UAT for EDC and integrated systems, including test plans and scripts.
• Assist with training sites/users on EDC applications and UAT.
• Ensure end-user knowledge for study conduct and data extraction.
• Lead studies or small data management project teams for clients.

Skills

MS Office

ICH Guidelines

21 CFR Part 11

GCP Knowledge

Data Management

Communication

Problem Solving

Data QA

EDC Testing

Team Leadership

Education

Bachelor's degree in science/medicine/clinical discipline

Tools

EDC Systems

MS Office Suite

Job description

Unknown CRO is seeking a Data Team Lead with at least five years of data management experience in clinical trials. You will oversee CRF tracking, data entry, data validation, and data quality across EDC systems, while leading small DM project teams for clients.

You will develop study metrics, guidelines, and data processes, and contribute to training and UAT activities to ensure regulatory compliance and data integrity.