Senior Clinical Data Manager

Jobtailor; Kennesaw (GA); On-site; USD 120,000 - 180,000; Full time

Job summary

Jobtailor in Kennesaw, GA seeks an experienced Clinical Data Manager to lead end-to-end data management for in-house and CRO trials, developing DMPs, CRFs, and edit checks.

You will oversee database build, testing, validation, and UAT in EDC systems, ensure data quality, and collaborate with cross-functional teams while ensuring GCP, FDA, MDR/IVDR compliance. Strong leadership and CDISC expertise are required; Python/R experience is a plus.

Qualifications

• Requires a Bachelor's or Master's degree in Life Sciences, Data Science, Computer Science, or related field.
• 7+ years of clinical data management, with 2+ years in senior/lead role.
• Experience with medical device trials or IDE/PMAs and 510(k) processes.
• Strong understanding of EDC systems and CDISC standards (CDASH/SDTM).
• Knowledge of FDA/EMA/GCP/GDPR regulatory requirements.
• Excellent organizational, leadership, and communication skills.
• Experience in FDA-regulated or ISO-certified environments is a plus.
• Advanced data visualization/analytics skills (Python/R) are a plus.

Responsibilities

• Lead, manage, and execute end-to-end data management activities for clinical trials (in-house or CRO).
• Develop and maintain Data Management Plans (DMPs), CRFs, edit check specs, and other essential docs.
• Oversee database build, testing, validation, and UAT in EDC systems.
• Ensure timely data collection, cleaning, reconciliation, and database lock.
• Collaborate cross-functionally with Clinical Operations, Biostatistics, Regulatory, QA, and CROs/vendors.
• Ensure data integrity and compliance with GCP, FDA, MDR/IVDR, and other standards.
• Contribute to protocol design, CRF design, and data flow diagrams.
• Conduct data reconciliation and external data integrations (labs, imaging), and MedDRA coding.
• Provide study-specific reports and data listings; support audits and inspections.
• Mentor juniors and contribute to process improvements and SOPs.

Skills

Data management leadership

EDC systems

CDISC standards

Regulatory compliance

Python/R

Mentoring

Cross-functional collaboration

Education

Bachelor's or Master's in Life Sciences / Data Science / CS

Tools

MedDRA coding

EDC platforms

Job description

Responsibilities

• Lead, manage, execute end-to-end data management activities for clinical trials conducted in‑house or outsourced to CROs.
• Develop and maintain Data Management Plans (DMPs), CRFs, edit check specifications, and other essential documents.
• Oversee database build, testing, validation, and UAT processes in EDC systems.
• Ensure timely and high-quality data collection, cleaning, reconciliation, and database lock activities.
• Collaborate cross‑functionally with Clinical Operations, Biostatistics, Regulatory Affairs, QA, and external CROs/vendors.
• Ensure data integrity and compliance with GCP, FDA, MDR/IVDR, and other applicable regulatory standards.
• Participate in and contribute to protocol development, case report form design, and data flow diagrams.
• Conduct and oversee data reconciliation, external data integrations (labs, imaging, etc.), and coding of medical terms (MedDRA, WHO-DD).
• Provide study‑specific reports and data listings on a regular basis and for ad‑hoc requests.
• Support audit readiness and participate in regulatory inspections when required.
• Mentor junior team members and provide strategic input into department process improvements and SOP development.

Requirements

• Bachelor's or Master’s degree in Life Sciences, Data Science, Computer Science, or a related field.
• 7+ years of clinical data management experience, with at least 2 years in a senior or lead role.
• Experience with medical device trials or combination products (IDE, PMA, 510(k), CE marking, etc.).
• Strong understanding of EDC systems and data standards (CDASH, SDTM, CDISC).
• Knowledge of regulatory requirements (FDA, EMA, ISO 14155, GCP, GDPR).
• Excellent organizational, leadership, and communication skills.
• Experience working in an FDA‑regulated and/or ISO‑certified environment (preferred).
• Advanced proficiency in data visualization tools and data analytics platforms (such as Python and/or R) is a plus (preferred).