Novo Nordisk Clinical Development Global Safety Team Vacancy
Novo Nordisk Clinical Development Global Safety Team Vacancy. MSc/BSc Life Science candidates are eligible to apply online for an Event Adjudication Professional I in Global Safety Team position that is available at Novo Nordisk, which is one of the world’s most successful pharmaceutical companies and with great growth potential.
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Novo Nordisk Vacancy Details
Designation: Event Adjudication Professional I in Global Safety Team
Category: Clinical Development and Medical
Location: Bangalore, Karnataka, IN
The Position:
As an Event Adjudication Professional I, you will be responsible for:
- Act as a project manager and coherent part of the EA trial team on outcome trials and point of contact to internal and external stakeholders from the planning/set-up phase until finalisation and archiving of documentation
- Keep relevant internal and external stakeholders informed of process progress and any changes to the overall project plan on an on-going basis (e.g. Study Group, EA Supplier)
- Contribute to external supplier selection in collaboration with GD Outsourcing management to ensure effective support of NN EA process including IT requirements in Safety Operations
- For delegated tasks act as the point of contact with the selected EA Supplier and ensure the involvement of stakeholders in GD and Global Safety according to NN procedures
- As project manager for delegated tasks contribute to Supplier prepared documents are reviewed and finalised according to timelines, procedures and the contract, e.g. EAC Charter, event adjudication System Requirement Specification (SRS), event adjudication Site Manual, Data Delivery Specification, Supplier Workflow, EAC Manual
- Support internal review of Supplier prepared documents (Charter, SRS, Site Manual, Supplier Workflow, EAC Manual) to ensure input from relevant stakeholders
- Support UAT of the event adjudication system
- Support review of internal documents (e.g. Trial Protocol, Monitoring Manual, EDC specification, Clinical Trial Report) to ensure that all relevant adjudication information is captured and inline/compatible with the event adjudication process
- Participate in EDC SPRINT and UAT
- Collaborate with relevant study group members throughout the trial and participate in status reporting of data
- Support the set-up of internal systems to support event adjudication (e.g. NEVAS)
- Support sites in performing tasks as outlined in the site manual, by providing overviews of events and solving individual queries
- Perform event processing of events relevant for adjudication according to agreed workflow
- The support that the event pipeline is well controlled by following supplier status and action at each relevant stage as well as participating in status meetings
- Participate in internal status meetings
- Support oversight of Supplier performance to ensure work is performed in accordance with agreed process documents, workflows and GCP
- QC the supplier’s query quality and processes in EDC.
- Provide feedback to the supplier with regard to improvements as a result of QC findings
- Escalate Supplier performance, if needed
- Support training of monitors and investigators in the handling of adjudication data in clinical trials (e.g. at Investigator and Monitor meetings)
- Ensure Audit and Inspection readiness
- Responsible for archiving of event adjudication documentation in the Trial Master File, including uploading, indexing and quality checking documents in novoDOCS
- Ensure relevant regulations (e.g. GCP) are followed
- Participate in audits and inspections
- Responsibility as Deviation responsible and CR owner (change owner, action owner) for the following tasks: preparing Deviation reports, Change Request cases and performing related actions when appropriate.
Qualifications:
You need to have the below knowledge, skills and experience.
- Post Graduate in Life Science with min. 2 years of relevant experience
OR
- Graduate in Life Science and combined with min. 4 years of relevant experience
- Experience with project management
- Knowledge of event adjudication, clinical development, clinical trial methodology and GCP requirements
- Knowledge of the FDA and EMEA guidelines related to adjudication and relevant endpoints
- Knowledge of diseases, their clinical manifestations, treatment and complications
- Experienced user of the Microsoft package specifically Excel
- Knowledge of clinical data collection methods, e.g. EDC.
- Fluent in English, both written and spoken
Personal skills:
- Team-oriented personality with a high degree of flexibility and cross-cultural awareness
- Good communication, presentation and negotiation skills
- Ability and willingness to adjust quickly to new situations in a continuously developing environment
- Good at sharing knowledge
- Ability to take initiative
- Systematic and organised
- Thorough and analytical
- Ability to work independently/in a team and ability to manage projects
Contact: For further information, please contact Shivalingappa at [email protected]
Deadline: 23 July 2020
APPLY ONLINE
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