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Novo Nordisk
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Head Clinical Operations Excellence

Head Clinical Operations Excellence

Novo Nordisk

3 - 15 years

0 Lacs

karnataka

Posted:2 days ago| Platform: Shine logo

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Skills Required

clinical operations clinical quality compliance team handling performance management stakeholder management risk assessments trend analyses audit inspection readiness capa documentation stakeholder communication quality management reviews training plans operational strategies innovative solutions digital visit tracking rbqm process improvements stakeholder satisfaction checks communication with regulatory authorities medical qualifications pharmacy qualifications life sciences qualifications digital tools systems excellent communication

Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: As the Head of Clinical Operational Excellence at Novo Nordisk, you will be responsible for ensuring clinical quality, compliance, and operational excellence. Your role will involve performing risk assessments and trend analyses to address clinical quality risks proactively, ensuring audit and inspection readiness, representing the CDC in regional and global clinical quality forums, coordinating Quality Management Reviews (QMR), driving innovative solutions for operational efficiency, and implementing process improvements. You will play a key role in communicating with external Regulatory Authorities FDA, EMA, CDSCO, PMDO, and ensuring compliance with local regulatory requirements. Key Responsibilities: - Perform risk assessments and trend analyses to proactively address clinical quality risks - Ensure audit and inspection readiness including CAPA documentation and stakeholder communication - Represent the CDC in regional and global clinical quality forums - Coordinate Quality Management Reviews (QMR) and develop yearly training plans aligned with operational strategies - Drive innovative solutions for operational efficiency such as digital visit tracking and RBQM - Identify and implement process improvements - Conduct stakeholder satisfaction checks and measure the effectiveness of new processes - Communicate with external Regulatory Authorities FDA, EMA, CDSCO, PMDO Qualifications Required: - 15+ years of experience in clinical operations with a minimum of 3 years in clinical quality - 5 years of direct team handling experience with 360* performance management - Completed qualifications in Medical, Pharmacy, Life Sciences, or related field - Track record of driving innovation and process improvements in clinical operations - Experience with digital tools and systems for operational excellence - Excellent communication and stakeholder management skills Company Details: The Clinical Development Centre (CDC) India at Novo Nordisk is dedicated to ensuring clinical quality and operational excellence. The department focuses on proactively addressing clinical quality risks, ensuring audit and inspection readiness, maintaining compliance with local regulatory requirements, driving innovative solutions like digital visit tracking and RBQM, and representing the CDC in global forums. The team fosters a culture of continuous improvement and operational efficiency to deliver impactful results. (Note: The above job description is tailored based on the provided information and may not include all details from the original JD.),

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Novo Nordisk

Pharmaceutical Manufacturing

Bagsværd Kalundborg

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Head Clinical Operations Excellence