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Sr. Manager Clinical Operations - Valencia, CA

Valencia, CA

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Description

Sr. Manager Clinical Operations - Valencia, CA (must have medical device background)

POSITION SUMMARY: Responsible for developing and conducting clinical trials/studies and ensuring that all programs are in compliance with FDA and other regulatory body regulations. Directs and manages the Clinical Affairs team, as well as external contractors, monitors and consultants. For each study, the Sr. Manager, Clinical Affairs is accountable for creating the clinical trial plan, then overseeing that the trial is conducted in compliance with GCP, FDA, ICH guidelines, and HIPAA requirements, national and local regulations, and company policies and procedures. In addition, the Sr. Manager, Clinical Operations will assist with regulatory submissions such as IDE/PMA, 510(k) and annual progress reports, as related to clinical trials from concept to study conclusion and reporting. SPECIFIC DUTIES AND RESPONSIBILITIES: • Drives the development, optimization, alignment, and implementation of clinical trial processes across the Clinical Operations group. • Oversees clinical management for pre-market trials and post-approval studies, and registry studies, including protocol development and training, CRO management, data capturing, biostatistical analysis, site monitoring, and timely reporting. • Partners with respective functions for development, optimization, and alignment of shared clinical trial processes. • Identifies and leads Process Improvement opportunities. • Provides Clinical Operations SME support to the Regulatory and Marketing teams. • Assists in the development of standard operating procedures (SOPs). • Directs the development of policies, procedures, and quality standards in Clinical Operations group. • Maintains awareness of changes within the industry and regulatory environment (i.e. ICH E6 (R3)) to ensure Clinical Development processes are updated as necessary. • Assists in developing department budget and is accountable for

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