Real Staffing

Compensation

Full Description

A Class III neuromodulation client of ours is looking for a Clinical Data Operations Manager to lead data strategy and integrity across global clinical programs supporting regulatory submissions, market access, post‑market surveillance, and product lifecycle management. This role is essential in ensuring high‑quality clinical evidence that drives product adoption, market expansion, and patient safety. You will lead clinical data processes across FDA‑regulated and MDR‑aligned environments while collaborating with Clinical Operations, Regulatory Affairs, Quality, R&D, and Biostatistics. Responsibilities Data Strategy & Regulatory Compliance • Develop, implement, and maintain SOPs and work instructions for clinical data management across global clinical programs. • Design and oversee clinical study databases aligned with FDA, QSR, GCP, and ISO 14155 requirements. • Manage and maintain clinical data systems, hardware, and software used in study execution. Clinical Data Quality & Reporting • Lead 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 quality, study performance, and cross‑study consistency. Cross‑Functional Leadership • Partner closely with Clinical Operations to align data management strategies with trial execution and enrollment goals. • Provide guidance and mentorship to internal teams and remote Clinical Data professionals. • Support global collaboration, including partnership with Sonova group companies, on data governance and operational excellence. Continuous Improvement & Resource Optimization • Drive process improvement initiatives to enhance efficiency, quality, and compliance across clinical data workflows. • Support resource planning and department‑wide initiatives that elevate clinical research and evidence generation. • Contribute to additional clinical research priorities as assigned. Reqruiements • Bachelor's Degree in Life Sciences, Data Science, Clinical Research, or a related discipline. • 5-7 years of experience in Clinical Data Management within an FDA‑regulated medical device or CRO environment. • Expertise with EDC systems and CTMS platforms (e.g., Medidata Rave, Oracle Inform, Veeva). • 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 decisions. • Preferred certifications: PMP, PRINCE2, ACRP, SOCRA, or Clinical Data Management credential. • Desirable: Experience with MS‑SQL, MS Access, object‑oriented programming languages, and data visualization tools (Power BI, Tableau, Python, R). APPLY NOW for immediate consideration! EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change. To find out more about Real, please visit www.realstaffing.com