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Clinical Data Manager
Hrcrs
- Nashville, Tennessee, United States
- Nashville, Tennessee, United States
À propos
We bring science, data, and collaboration together in a single, full-service CRO model powered by real-world evidence (RWE).
By combining deep cardiovascular expertise, an engaged and diverse network of physicians, and close client partnerships, we transform data into evidence that fuels innovation and leads to better care.
Our growing network of experts and institutions powers every project we deliver — enabling collaboration, scalability, and measurable results.
270+
Cardiovascular Specialists
100+
Signed Data Sharing Agreements
3+
4
Countries represented
About the role We are seeking an experienced Clinical Data Manager to lead and oversee data management activities for medical device clinical trials, with a focus on Electrophysiology (EP). This role involves ensuring high-quality, regulatory‑compliant data collection and analysis to support clinical trials from start‑up to submission.
The ideal candidate will have expertise in clinical data management, regulatory compliance, and database development, with a strong understanding of clinical trial processes in the medical device industry. Experience in Electrophysiology (EP) trials is a plus but not mandatory.
What you’ll do Clinical Data Management & Oversight
Lead all aspects of data management for
medical device clinical trials , ensuring compliance with FDA, MDR, ICH‑GCP, and ISO 14155 regulations.
Develop and maintain
Data Management Plans (DMPs)
and
Case Report Forms (CRFs)
aligned with study protocols.
Design, validate, and manage
Electronic Data Capture (EDC) systems
such as Medidata RAVE, Oracle InForm, or Veeva Vault EDC.
Oversee data cleaning, query management, and reconciliation processes to ensure high-quality, analyzable datasets.
Ensure adherence to
CDISC/CDASH/SDTM standards , enabling efficient regulatory submission.
Conduct and support
data audits, quality control (QC) reviews, and database lock activities .
Serve as the
data management lead
for multiple studies, collaborating with cross‑functional teams including
clinical operations, biostatistics, and regulatory affairs .
Work closely with
electrophysiology (EP) experts, principal investigators, and clinical research teams
to ensure accurate data collection and interpretation.
Provide mentorship and guidance to
junior data managers
and other team members.
Manage relationships with
CROs, vendors, and external data management teams , ensuring alignment with project timelines and quality standards.
Regulatory Compliance & Quality Assurance
Ensure compliance with
FDA 21 CFR Part 11, ICH‑GCP, ISO 14155 (for medical devices), and MDR regulations .
Support
regulatory submissions (e.g., PMA, 510(k), CE Mark, IDE)
by ensuring proper data documentation and formatting.
Participate in
audits and inspections
by regulatory bodies and implement corrective actions as needed.
Stay updated on evolving
medical device data management
best practices and regulatory requirements.
Data Reporting & Analysis
Generate and review
clinical study reports, data listings, and reconciliation outputs .
Support statistical programming and data analysis in collaboration with
biostatistics teams .
Ensure seamless data integration with clinical trial management systems (CTMS) and safety databases.
Qualifications Education & Certifications
Bachelor's or Master's degree in
Life Sciences, Clinical Research, Biostatistics, Computer Science, or a related field .
Certified Clinical Data Manager (CCDM)
or equivalent certification is a plus.
Experience
5+ years of experience
in clinical data management within the
medical device industry
or related healthcare sectors.
Proven experience in
Phase I‑IV clinical trials, IDE/PMA/510(k) submissions, or post‑market studies .
Strong knowledge of
electrophysiology (EP) trials is a plus but not required .
Experience managing
EDC systems (e.g., Medidata RAVE, Veeva Vault, Oracle InForm, Medrio) .
Familiarity with
ISO 14155, CDISC/CDASH/SDTM, and FDA 21 CFR Part 11 compliance .
Knowledge of
SQL, SAS, or other clinical data programming tools
is beneficial.
Strong
leadership, problem‑solving, and analytical
abilities.
Excellent attention to detail and ability to
manage multiple clinical studies simultaneously .
Strong communication and collaboration skills for working with
clinical, regulatory, and biostatistics teams .
Ability to work effectively with
CROs, vendors, and external stakeholders .
LOCATION AND TRAVEL REQUIREMENTS: This is a fully remote position and may be performed anywhere within the United States of America. Occasional domestic travel may be required for company meetings, audits, etc.
This employer participates in E‑Verify and will provide the federal government with your Form I‑9 information to confirm that you are authorized to work in the U.S.
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Compétences linguistiques
- English
Avis aux utilisateurs
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