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Novo Nordisk
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Central Monitor

Central Monitor

Novo Nordisk

2 - 5 years

4 - 7 Lacs

Bengaluru

Posted:5 days ago| Platform:

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Skills Required

python sas sql r clinical research medical writing medical monitoring drug safety presentation skills clinical data management pharmacovigilance medical summarization medical affairs cra analytical instruments meddra clinical trials

Work Mode

Work from Office

Job Type

Full Time

Job Description

Novo Nordisk Global Business Services (GBS), India
Department- Centralised Monitoring Unit (CMU)- Bangalore
Does your motivation come from challenges and working in a dynamic environmentDo you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essentialDo you have a can-do attitude with continuous improvement as one of your career objectivesThen 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)- Bangalore, is a department within the Global Trial Portfolio area. It is a perfect blend of skilled medical professionals (Medical reviewers), technical programmers (Functional programmers, statistical monitors) and Medical Illustrators. Medical reviewers actively involved in Risk based medical monitoring in collaboration with the medical specialists from Denmark, with 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 requires medical attention and medical data cleaning. The Functional Programmers develop operational visualisations in data visualization tools to support the trial teams on proactive centralised monitoring and Statistical Monitors perform detection of unusual data patterns, systematic errors and potential lack of compliance or fraud across trials. Medical Illustrators are responsible for developing engaging visual content for our clinical meetings. 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.

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 . 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.

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.

Qualifications

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

Above 3 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 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.

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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