Central Monitor

5 days ago


Bengaluru Karnataka, India Novo Nordisk Full time

Central Monitor

**Category**:Clinical Development**Location**:Bangalore, Karnataka, IN

**Department - Centralised Monitoring Unit (CMU)
- Bangalore**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), medical illustrators (graphical designers), technical programmers (Functional programmers), statistical monitors and central monitors. 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. Our medical illustrators create visually appealing content for our clinical meetings and central monitors perform review of key risk indicators.**The Position**- 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.
- 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.

**Qualifications**:

- Minimum of bachelor’s 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 software’s
- 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 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.

**Working at Novo Nordisk**
- Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognise the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us Together, we go further. Together, we’re life changing.**Contact**Deadline**Disclaimer**
- It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process._
- We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.- At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we kno


  • Central Monitor

    2 weeks ago


    Bengaluru, India ICON Full time

    ICON is looking for a Central Monitor to be based in Chennai. The Central Monitor is responsible for listing review and central data analysis to support quality and risk reviews of projects, by highlighting/escalating trends. Job Responsibilities As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement...


  • Bengaluru, India ScaleneWorks Full time

    Single point of accountability to embed the application of Risk Based Quality Management aligned with the study planning, study protocols, GSK SOPs, ICH GCP and regulatory requirements for assigned GSK sponsored and outsourced studies.; includes the set up and execution of Central Monitoring and Data Analytics tool. Drive discussions with Global Clinical...

  • Central Monitor

    4 weeks ago


    Bangalore, Karnataka, India Novo Nordisk Full time

    Novo Nordisk Global Business Services GBS India Department - Centralised Monitoring Unit CMU - Bangalore 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...

  • Central Monitor

    4 weeks ago


    Bangalore, Karnataka, India Icon Full time

    OverviewAs a job title you will be joining the worlds largest most comprehensive clinical research organisation powered by healthcare intelligence ResponsibilitiesWe are seeking a highly experienced Clinical Trial Risk Management Specialist with a strong pharmaceutical industry background The ideal candidate will possess extensive expertise in clinical trial...


  • Bengaluru, India IQVIA Full time

    Job Overview Provide project related assistance to assigned project teams.; Ensure all work is conducted in accordance with standard operating procedures, policies, good clinical practices and applicable regulatory requirements.; Meeting quality and timeline metrics.; Essential Functions - Complete appropriate role-specific training to perform job duties. -...


  • Bengaluru, India Novasyte Full time

    Job Family Description: A technical leadership role that drives adoptions and customization of operational tech tools and support to move to a more digital way of working aligned with the DCOM strategy. Able to lead/oversight to the overall clinical tech set-up and more readily provide solutions to the available data to resolve issues across our portfolio....


  • Bengaluru, India PPD Full time

    **Summarized Purpose**: Performs site management and other related activities on assigned project(s) in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and PPD SOPs. Reviews study data from various sources remotely. Develops collaborative relationships with investigational sites and other stakeholders as applicable. May...


  • Karnataka, India ASSPL - Karnataka Full time

    Bachelor's degree in a quantitative/technical field such as computer science, engineering, statistics - Experience with Excel **Job Summary**: The Central Ops Support Executive is expected to remotely support the daily operations of Fresh business along with other CST activities of sellers, including daily metrics monitoring, triggering on field support to...


  • Bengaluru, Karnataka, India, Karnataka Ather Energy Full time

    Vertical: BusinessDepartment: Central OpsDivision: SalesUnique Role: Central Operations ManagerOperational Responsibilities Develop and drive process improvements for sales processes and RP managementScheduling of zonal wholesales for vehicles based on production plan and sales plan.Monitor and maintain optimum inventory levels at RDCs and plan...


  • Karnataka, India Amazon.com Full time

    DESCRIPTION Job Summary: The Central Ops Support Executive is expected to remotely support the daily operations of Fresh business along with other CST activities of sellers, including daily metrics monitoring, triggering on field support to sellers and audits, stake holder management, within and outside of Amazon, rolling out of new processes, and running...