Senior Clinical Data Manager

Artivion, Inc.

Sr. Clinical Data Manager at medical device company responsible for data management activities.

Posted 7/2/2026full-timeKennesaw • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading clinical data management activities, ensuring data integrity and compliance with regulatory standards such as GCP and FDA. Proficient in developing Data Management Plans and overseeing EDC systems, with a strong focus on collaboration across clinical operations and biostatistics.

Highest-signal resume keywords

Clinical Data ManagementData Management Plans (DMPs)EDC SystemsRegulatory Compliance (GCP, FDA)Data Visualization (Python, R)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Data ManagementData Management Plans (DMPs)Database BuildData CleaningData ReconciliationEDC SystemsData Standards (CDASH, SDTM, CDISC)Medical Coding (MedDRA, WHO-DD)Data AnalyticsData Visualization

Soft Skills

LeadershipCommunicationOrganizational Skills

Tools & Technologies

EDC SystemsData Visualization ToolsData Analytics Platforms

Certifications & Qualifications

Bachelor's DegreeMaster's Degree

Industry Keywords

Clinical TrialsCROFDA RegulationsISO 14155MDR/IVDRMedical Device TrialsCombination Products

Tech Stack

Tools & technologies

Google Cloud PlatformPython

About the role

Key responsibilities & impact

Lead, manage, execute end-to-end data management activities for clinical trials conducted inhouse or outsourced to CRO’s.
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 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

What you’ll need

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).

Benefits

Comp & perks

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