Senior Clinical Data Manager

Artivion, Inc.

Sr. Clinical Data Manager at Artivion managing data for clinical trials and ensuring regulatory compliance.

Posted 5/19/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

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
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

Benefits

Comp & perks

Health insurance
Professional development
Flexible work arrangements

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

data managementData Management Plans (DMPs)case report form designdata reconciliationexternal data integrationscoding of medical termsEDC systemsdata standardsregulatory complianceclinical data management

Soft Skills

leadershiporganizational skillscommunication skillsmentoringstrategic input

Certifications

Bachelor's degreeMaster’s degree