Novo
Nordisk, Event Adjudication Professional I in Global Safety team Graduate in
lifes Science / Post Graduate in life Science
The
position
As
an Event Adjudication Professional I, you will be responsible for:
Act
as project manager and coherent part of the EA trial team on outcome trials and
point of contact to internal and external stakeholders from 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 point of contact with the selected EA Supplier and ensure
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 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 in line / 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
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 suppliers 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 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
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 relevant experience
OR
Graduate
in lifes Science and combined with min. 4 years 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
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