Sr. Clinical Data Manager

Scorpion Therapeutics; Kennesaw (GA); On-site; USD 110,000 - 160,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Clinical Data Manager to oversee data management for medical device clinical trials, ensuring data integrity from study start-up to database lock. This role leads end-to-end data activities and mentors junior staff in a fast-paced, cross-functional environment.

The ideal candidate has 7+ years in clinical data management, strong EDC/CDISC expertise, and a deep understanding of FDA/EMA/ISO standards.

Qualifications

• Bachelor’s or Master’s in Life Sciences, Data Science, or related field.
• 7+ years in clinical data management with 2+ years in a senior/lead role.
• experience with medical device or combination product trials (IDE, PMA, 510(k)).
• strong EDC, CDASH, SDTM, and CDISC knowledge.
• understanding of regulatory standards (FDA, EMA, ISO 14155, GDPR)

Responsibilities

• lead end-to-end data activities, develop and maintain study documents, oversee database build, testing, and validation
• collaborate cross-functionally with Clinical Operations, Biostatistics, Regulatory, QA, and CROs
• ensure compliance with GCP, FDA, MDR/IVDR standards
• support audits and regulatory inspections
• mentor junior staff and contribute to process improvements

Skills

EDC

CDASH

SDTM

CDISC

Education

Bachelor’s or Master’s in Life Sciences, Data Science, or related field

Tools

Python

R

Job description

Role: Senior Clinical Data Manager overseeing data management for medical device clinical trials, ensuring data integrity from study start-up to database lock.

Responsibilities:

• lead end-to-end data activities, develop and maintain study documents, oversee database build, testing, and validation
• collaborate cross-functionally with Clinical Operations, Biostatistics, Regulatory, QA, and CROs
• ensure compliance with GCP, FDA, MDR/IVDR standards
• support audits and regulatory inspections
• mentor junior staff and contribute to process improvements

Requirements:

• Bachelor’s or Master’s in Life Sciences, Data Science, or related field
• 7+ years in clinical data management with 2+ years in a senior/lead role
• experience with medical device or combination product trials (IDE, PMA, 510(k))
• strong EDC, CDASH, SDTM, and CDISC knowledge
• understanding of regulatory standards (FDA, EMA, ISO 14155, GDPR)

Preferred:

• experience in FDA-regulated/ISO-certified environments
• proficiency in data visualization and analytics tools (Python, R)

HighValue: medical device (vascular/surgical), clinical trials, GCP, FDA/EMA compliance, database management, cross-functional collaboration.

WorkSetup: not specified.