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Senior Central Monitor Professional

Senior Central Monitor Professional

Name: Jobpe
Address: T-Hub, Plot No 1/C, Sy No 83/1, Raidurgam panmaktha, Knowledge City Rd, Hyderabad, Telangana, 500081, IN
Telephone: +91-83339-09630
Price range: Free

Novo Nordisk

5 - 10 years

4 - 8 Lacs

bengaluru

Posted:23 hours ago| Platform:

Apply

Skills Required

compliance clinical operations python medical pr data analytics ai regulatory compliance research sql analytics data quality ai tools r quality management data cleaning gcp clinical research data visualization life science

Work Mode

Work from Office

Job Type

Full Time

Job Description

The Position

As 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 (KRIs) 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.

Lead the development and execution of centralised monitoring processes within a Risk-Based Quality Management (RBQM) framework, ensuring alignment with global standards and continuous improvement on assigned studies using vendor platform dashboards/outputs in accordance with NN SOPs, ICH/GCP, regulatory guidelines & directives.
Design and implement advanced operational monitoring strategies, leveraging data analytics, digital tools, and AI-powered solutions for enhanced risk detection and process optimisation.
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. Prior experience with RBQM (Risk-Based Quality Management) and field monitoring as a CRA is desirable. Familiarity with analytical tools is preferred, as well as experience using SAS, Python, R, and SQL are desirable.
Drive process optimisation initiatives to improve efficiency, including strategies to enhance Clinical Research Associate (CRA) productivity and effectiveness.
Provide subject matter expertise on central monitoring methodologies, systems, and tools, mentor and train team members across operational, medical, and statistical domains.
Respond to monitoring findings, audits, and inspections, ensuring robust corrective actions and process enhancements.
Champion a culture of innovation, continuous improvement, and knowledge sharing across the CMU and broader organisation.
Represent the CMU in cross-functional and global initiatives, influencing the adoption of smart, digital, and AI-driven approaches.

Qualifications:

Minimum of bachelors degree in life science/scientific or health care discipline.
Above 5 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
Expert knowledge of Good Clinical Practice (GCP), with emphasis on ICH-GCP E6 R2 and R3 guidelines, and a proven RBQM mindset.
Experience in process optimisation and driving efficiency, particularly in supporting and enabling CRA teams. Skill in aggregate data review and interpretation using visualization/analysis softwares
Solid understanding of clinical trial design, trial execution and operations. Ability to successfully manage multiple projects and priorities. Good Communication & Presentation skills.
Ability to work collaboratively and effectively in a cross functional and culturally diverse teams.
Strong technical skills, including data analytics, visualisation software, and digital tools. Basic understanding of AI tools and their application in clinical operations is highly desirable. Ability to work independently/responsively and with tight s 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. Experience working with Clue Points solutions will be an advantage.

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Novo Nordisk

Pharmaceutical Manufacturing

Bagsværd Kalundborg

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Senior Central Monitor Professional