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If your dream is to help close to 400 million people worldwide by taking part in developing the world’s leading diabetes product portfolio and ensuring delivery of reliable clinical data, we have a position which will be of interest to you.

Department & Responsibilities:
We are seeking a talented and engaged characterisation Senior Start Up Specialist CRA to join Clinical Research function, based in Bangkok office. You will join a clinical research team of 10 dynamic colleagues under the Clinical, Medical, Regulatory and Quality (CMRQ) department. In 2016,the Society for Clinical Research Sites (SCRS), an international organisation representing the interest of the clinical sites, has awarded Novo Nordisk the Eagle Award as the winning sponsor. This award recognises outstanding leadership, professionalism, integrity, passion and dedication to advancing the clinical research profession through a strong site partnership. We are responsible for conducting global clinical trials from phase 1-4 from country allocation to trial closure. At Novo Nordisk, we have strong pipelines and believe in taking ownership of developing our own molecules from lab to investigation in subjects. As a member of team, you will

The sCRA responsibilities in site management include (80-100%):

• Familiarise themselves with all applicable local submission guidelines from health        authority, IRB’s, IEC’s etc
• Preparation and submission of local Clinical Trial Application to Health Authorities and IRB/IEC as soon as possible to obtain all necessary regulatory approvals within defined timelines.
• Drive quality mind-set for the submission process.
• Informing relevant internal stakeholders of the local CTA documents requirement for specific trial projects needed throughout the trial. And update Clinical trial local requirement system timely.
• DFU, Label: Customization, Translation, and Communication to CS-Label Team
• Liase with CTA’s and /or Clinical trial sites with respects to obtaining submission documents from selected sites.
• Ensure that the documents are timely collected and in compliance with NNSOP and regulatory requirements.
• SIIC: Customization, Translation, Review, and Approval; Preparing Log of Changes
• Protocol and IB Signature Page: Preparation and tracking
• Update and review Protocol Attachment II
• Customisation of Master (patient) Documents and obtaining approvals from Global team.
• Coordination of translation with approved local/global vendors (where applicable).
• Liase with CQTM with respect to obtaining local clinical trial insurance documents.
• Liases with CTA’s with respect to the collation of the submission files.
• Responsible for responding to Health Authority, IRB’s and IEC’s queries timeously.
• Obtaining EC approval, signed CTA (incl. amendment), signed MTA (incl. amendment) and trial supplies import license.
• Proactive use of IT Systems (e.g. IMPACT, novoDocs, or other similar) for preparation.
• Preparation and submission of reports to local Clinical Trial Application to Health Authorities and IRB/IEC as soon as possible within defined timelines.
• Ensure collaboration with and deliveries from vendors (e.g. translators) locally.
• Therapeutic knowledge and general understanding of diseases and treatments and protocol.
• Follow CDC escalation pathway for site related issues
• Set-up initial greenlight file and hand it over to CRA after all approvals are inhouse.
• Primary responsible person for communication with HA and ECs during the trial lifecycle
• Support the coordination of feasibility activities, site selection, as required, in accordance with agreed timelines
• Upload responsible document in TMF until before handover to CRA
• Negotiate Contracts with clinical trial’s sites and Investigators and track of payments (if applicable)
• Coordinate with monitors to identify any gaps in start-up processes to ensure sites have required materials, resources, and training to initiate the trial