Associate Central Monitor

2 weeks ago

Bengaluru, India Novo Nordisk AS Full time

Department – Centralised Monitoring Unit (CMU)

Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might have the right position for you. Apply now and join a growing team, working in an international environment.

About the department

The Centralised Monitoring Unit (CMU), is a department within the Clinical Drug Development area. It is a perfect blend of skilled medical professionals (Medical reviewers) and technical programmers (Functional programmers, statistical monitors). Medical reviewers are actively involved in Risk-based medical monitoring in collaboration with the medical specialists from Denmark, with a focus on ensuring overall patient safety and wellbeing of all clinical trial participants, by ensuring compliance to protocol and identifying potential clinically significant outliers that require medical attention and medical data cleaning. The Functional Programmers develop operational visualizations in data visualization tools to support the trial teams on proactive centralized monitoring and Statistical Monitors perform detection of unusual data patterns, systematic errors, and potential lack of compliance or fraud across trials.

The Position

As an Associate 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 before the start of centralized operational monitoring review.

Responsible for performing ongoing centralized operational monitoring activities on assigned studies using vendor platform dashboards/outputs by 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 the 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 sharing 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.

Qualifications:

Minimum of bachelor’s degree in life science/scientific or health care discipline. Above 2 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 Solid understanding of clinical trial design, trial execution, and operations. Ability to successfully manage multiple projects and priorities. Good Communication & Presentation skills. Ability to plan well and handle complex tasks simultaneously and independently. Ability to work collaboratively and effectively in cross-functional and culturally diverse teams. Ability to work independently/responsively and with tight deadlines and under pressure. Quality mindset and strong analytical skills, Strong attention to detail, Proactive and resilient to changes. Interact with colleagues, stakeholders, project members, and management proactively and professionally.

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