Lead Remote Clinical Data Manager

CryoLife, Inc.; Kennesaw, Northern (GA, KY); Hybrid; USD 110,000 - 160,000; Full time

Job summary

Artivion, Inc. seeks a Sr. Clinical Data Manager to lead end-to-end data management for clinical trials, including database setup, testing and reconciliation. You will collaborate with CROs and internal teams to ensure data integrity from start-up to database lock.

The role requires 7+ years in clinical data management, a life sciences or related degree, and deep knowledge of FDA/EMA regulations. Proficiency in EDC and CDISC standards, with strong leadership and communication skills.

Qualifications

• 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).
• 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.

Responsibilities

• Lead end-to-end data management activities for clinical trials.
• Develop and maintain Data Management Plans (DMPs) and CRFs.
• Oversee database build and 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.
• Ensure data integrity and regulatory compliance.
• Contribute to protocol development and CRF design.
• Handle data reconciliation and external data integrations.
• Provide study reports and ad-hoc data listings.
• Support audit readiness and regulatory inspections; mentor junior staff.

Skills

Leadership

Data management

Cross-functional collaboration

Regulatory knowledge

Education

Life Sciences / Data Science / Computer Science degree

Tools

EDC systems

CDASH

SDTM/CDISC

Job description

Artivion, Inc. seeks a Sr. Clinical Data Manager to lead end-to-end data management for clinical trials, including database setup, testing and reconciliation. You will collaborate with CROs and internal teams to ensure data integrity from start-up to database lock.

The role requires 7+ years in clinical data management, a life sciences or related degree, and deep knowledge of FDA/EMA regulations. Proficiency in EDC and CDISC standards, with strong leadership and communication skills.