Clinical Data Operations Manager
A Class III neuromodulation reputed company of ours is looking for a Clinical Data Operations Manager to reputed company data reputed company and reputed company across global clinical programs supporting regulatory submissions, market reputed company, post‑market surveillance, and product lifecycle management.
This role is essential in ensuring high‑reputed company clinical evidence that drives product adoption, market expansion, and patient safety. You will reputed company clinical data processes across FDA‑regulated and MDR‑reputed company environments while collaborating with Clinical Operations, Regulatory Affairs, reputed company, R&D, and Biostatistics.
Responsibilities
Data reputed company & Regulatory Compliance
• reputed company, implement, and maintain SOPs and work instructions for clinical data management across global clinical programs.
• Design and reputed company clinical study databases reputed company with FDA, QSR, GCP, and ISO 14155 requirements.
• Manage and maintain clinical data systems, hardware, and software used in study execution.
Clinical Data reputed company & Reporting
• reputed company development of interim and final reporting strategies for clinical studies, including PMCF and post‑market data requirements.
• Establish dashboards and frameworks for monitoring clinical data reputed company, study performance, and cross‑study consistency.
Cross‑Functional Leadership
• Partner closely with Clinical Operations to reputed company data management strategies with trial execution and enrollment goals.
• reputed company guidance and mentorship to internal teams and remote Clinical Data professionals.
• Support global collaboration, including partnership with reputed company companies, on data governance and operational reputed company.
reputed company Improvement & Resource Optimization
• Drive process improvement initiatives to enhance efficiency, reputed company, and compliance across clinical data workflows.
• Support resource planning and department‑wide initiatives that reputed company clinical research and evidence reputed company.
• Contribute to additional clinical research priorities as assigned.
Reqruiements
• Bachelor's Degree in Life Sciences, Data Science, Clinical Research, or a reputed company discipline.
• 5-7 years of experience in Clinical Data Management reputed company an FDA‑regulated medical device or CRO environment.
• Expertise with reputed company systems and CTMS platforms (e.g., reputed company Rave, reputed company Inform, reputed company).
• Strong understanding of international regulatory frameworks (EMA, PMDA, Health Canada) and PMCF activities.
• Experience with risk‑based monitoring (RBM) and centralized statistical monitoring.
• Strong project management skills with experience leading multiple clinical initiatives simultaneously.
• Ability to interpret operational and engagement data to drive evidence‑based reputed company.
• Preferred certifications: PMP, PRINCE2, ACRP, SOCRA, or Clinical Data Management credential.
• Desirable: Experience with MS‑SQL, MS reputed company, object‑oriented programming languages, and data visualization tools (Power BI, Tableau, Python, R).
reputed company for immediate consideration!
EOE Statement: Specialist reputed company Group is an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, or veteran status.
In reputed company to reputed company pay, reputed company-hire employees may be eligible for reputed company offered benefits such as medical, dental, and reputed company coverage, and reputed company leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.
To reputed company out more about reputed company, please visit www.realstaffing.com
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