Central Monitor

1 month ago


Bengaluru, India Novo Nordisk Full time

   

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 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)- 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

 

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 (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.

 

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

If you believe you are a match for the above requirements and are willing to take up the role, please apply here with our online application tool.

 

Deadline

Apply on or before: 28th November 2024.

 

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 know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

 


  • Centralized Monitoring

    6 months ago


    Bengaluru, India 14260 GSK India Global Services Private Limited Full time

    Key Responsibilities ​ 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...

  • Central Monitor

    1 month 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),...


  • Bengaluru, India Novasyte 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...


  • Bengaluru, India IQVIA 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 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, Karnataka, India myGwork Full time

    Company Overview: myGwork is an inclusive employer and a member of the largest global platform for the LGBTQ+ business community.About This Role: As a Security Operations Specialist, you will serve as an operational resource to support the Security Command Center for ATS. Your key responsibilities include providing comprehensive program security guidance,...


  • Bengaluru, Karnataka, India HyrEzy Talent Solutions Full time

    About HyrEzy Talent SolutionsWe are your go-to partner for all your business technology needs. With strong expertise in Salesforce CRM setup, IT services, support, and staffing, we're committed to helping businesses of all sizes succeed. Our experienced team can smoothly integrate Salesforce into your operations, making it easier to manage customer...


  • Bengaluru, Karnataka, India HyrEzy Talent Solutions Full time

    About the Role:We are seeking a seasoned Business Central Architect to join our internal team at HyrEzy Talent Solutions. As a Business Central Architect, you will play a critical role in designing, implementing, and optimizing Microsoft Dynamics 365 Business Central solutions tailored to our institution's needs.Main Responsibilities:Lead the architecture...


  • Bengaluru, India ATSPL - Karnataka Full time

    The Control Room Specialist – CMRS (Centralized Monitoring and Response System) position serves as operational resource to support the Security Command Center for ATS. This position will act as a shift in charge and provide support and accountability for the overall deliverables of the command center. The control room will be functional 24/7, hence this...


  • Bengaluru, India myGwork Full time

    This job is with Amazon, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.DESCRIPTION:The Control Room Specialist - CMRS (Centralized Monitoring and Response System) position serves as operational resource to support the Security Command Center for...

  • Central Operations

    6 months ago


    Bengaluru, India YTPS HR Services Full time

    **Manager, Central Operations & Process Excellence**: **About the role**: The Manager of Operations will lead and champion process improvement initiatives across the operations function, driving efficiency, effectiveness, and scalability. This individual will work closely with field teams to identify, design, and implement optimized Operation processes. The...


  • Bengaluru, Karnataka, India We IT Global AB Full time

    Job RequirementsWe IT Global AB is seeking a skilled Centralized Schema Registry Architect to assist us in building a cutting-edge Centralized Schema Registry using the Apicurio Registry as a self-managed service. The successful candidate will be responsible for:Architecting and optimizing the Centralized Schema Registry for seamless performance and...


  • Bengaluru, Karnataka, India Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in...


  • Bengaluru, Karnataka, India Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...


  • Bengaluru, Karnataka, India QuestAlliance Full time

    Published 2024-12-05 **About Quest Alliance** Quest Alliance transforms learning ecosystems through education technology, capacity building, and collaboration to build 21st-century skills for learners and facilitators. As a not-for-profit trust, we drive research-led innovation and advocacy in teaching and learning. By partnering with educators, civil...

  • Success Factor

    6 months ago


    Bengaluru, India Shifastar Full time

    **Job description** **Employee Central**: - Minimum 5 years of experience in design and configuration of SuccessFactors Employee central. - Must have 2 TO 3 full life cycle implementations/Support experience for Employee central - Expertise on Data models configuration. - Workflows, event reason configuration and Business rules. - Foundation and Generic...

  • Success Factor

    6 months ago


    Bengaluru, India Shifastar Full time

    **Employee Central**: Minimum 5 years of experience in design and configuration of SuccessFactors Employee central. - Must have 2 TO 3 full life cycle implementations/Support experience for Employee central - Expertise on Data models configuration. - Workflows, event reason configuration and Business rules. - Foundation and Generic object configuration and...


  • Bengaluru, Karnataka, India ATSPL - Karnataka Full time

    Job DescriptionThe Centralized Security Operations Lead role at ATSPL is a critical position that requires a highly skilled and experienced professional to oversee the security operations of our organization. The ideal candidate will have a strong background in security management, with experience in control room management, law enforcement, loss prevention,...


  • Bengaluru, Karnataka, India ASSPL - Karnataka Full time

    Job OverviewWe are seeking an experienced Senior Operations Leader to join our Central Support Team at ASSPL - Karnataka. This role will play a crucial part in supporting the daily operations of sellers, ensuring efficient functioning, and driving opportunities for efficiency.About the RoleThe ideal candidate will have a bachelor's degree and strong skills...

  • Operations Director

    1 month ago


    Bengaluru, Karnataka, India SATS Ltd. Full time

    Job SummarySATS Ltd. seeks an experienced Operations Director to oversee the day-to-day operations of a central kitchen in Bengaluru, ensuring seamless and efficient operations, inventory management, and compliance with food safety regulations.About UsSATS Ltd., a leading provider of food solutions, is committed to delivering exceptional quality and service...