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Senior Central Monitor

Senior Central Monitor

Novo Nordisk

6 - 11 years

8 - 12 Lacs

bengaluru

Posted:6 days ago| Platform:

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Skills Required

compliance gcp clinical development clinical research healthcare data quality data visualization continuous improvement operations recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

The Position

As Senior Central Monitor, an ideal candidate will be responsible for providing inputs in defining standard and trial specific key risk indicators and performing ongoing monitoring of operational risks. Ensure both standard and trial specific Key Risk Indicators (KRI s) impacting patient safety and data quality and regulatory compliance are appropriately defined as per protocol, monitoring strategy etc prior to start of centralised operational monitoring review .

Responsible to Perform ongoing centralised operational monitoring activities on assigned studies using vendor platform dashboards/outputs in accordance with NN SOPs, ICH/GCP, regulatory guidelines directives.

Provide inputs to applications, databases and systems used to monitor operational data.

Responsible for communication and findings of operational review to relevant stakeholders to enable decision making. Act as primary contact for relevant stakeholders and participate in project meetings for assigned centralized monitoring studies .

Contribute to discussions around share learnings and practices with wider CMU department colleagues and with other relevant stakeholders

Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements.

Drive continuous improvement initiatives leveraging data analytics and performance metrics to optimize monitoring practices and enhance study quality

Provide technical inputs for smooth implementation of RBQM strategies, processes, and standards to ensure consistent, efficient, and high-quality deliverables

Provide mentorship and guidance to junior monitoring staff, supporting their professional development and growth within the organization.

Qualifications :

Minimum of bachelor s degree in life science/scientific or health care discipline.

Above 6+ years of relevant clinical research experience with good knowledge of drug development process and risk-based quality management principles.

Prior CRA/Field Monitoring and analytical tool experience is desirable

Skill in aggregate data review and interpretation using visualization/analysis software s

Solid understanding of clinical trial design, trial execution and operations.

Ability to successfully manage multiple projects and priorities.

Good Strong Communication Presentation skills.

Ability to plan well and handle complex tasks simultaneously and independently.

Ability to work collaboratively and effectively in a cross functional and culturally diverse teams.

Ability to work independently/responsively and with tight deadlines and under pressure.

Quality mind-set and strong analytical skills, Strong attention to detail , Proactive and resilient to changes .

Interact with colleagues, stakeholders, project members, management in a proactive and professional manner.

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Novo Nordisk

Pharmaceutical Manufacturing

Bagsværd Kalundborg

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Senior Central Monitor