Clinical Trial Administrator

3 weeks ago


Bengaluru, India Novo Nordisk AS Full time

Department – Clinical Trial Administration

Are you looking for a challenging role in the pharmaceutical industry? Do you have experience in clinical trial administration? We are seeking a Clinical Trial Administrator to join our team in Bangalore. If you are detail-oriented, organized, and ready to contribute to life-changing research, read on and apply today for a life-changing career.

The position

A Clinical Trial Administrator (CTA) plays a crucial role in the coordination and management of clinical trials within the pharmaceuticals. The CTA provides support to the CDC PMs and CRAs in relevant aspects of trial start up, execution and closure, and facilitate timely clinical project deliverables of required quality, below are few responsibilities mentioned as per the position requirement:

Providing clinical trial administration support to the CDC PMs and CRAs in relevant aspects of trial start-up, execution, and closure. Facilitating timely clinical project deliverables of required quality. Translation and verification of study documents and patient materials. Preparation of contracts and agreements, obtaining necessary signatures, and uploading to electronic systems. Updating national clinical trial registers with new or updated study-related information. Supporting PM with drug consumption plans and sample export plans. Tracking study-specific events and/or documents and maintaining appropriate tools and logs. Attending project meetings, taking minutes, and following up on action items. Supporting in arranging local IM and other departmental meetings or related activities. Managing shipment clearances and procurement of materials from vendors. Timely processing of vendor invoices and preparation of sponsor TMF documents for long-term archival.

Qualifications

To be successful in this role, you should have the following qualifications:

Graduate or Postgraduate in Pharmacy or Lifesciences or other related fields. 5 years of work experience as a department assistant or in a relevant job in the pharmaceutical industry. Intermediate data management skills, including computer literacy in Word, Excel, and PowerPoint. Good Communication and should be able to collaborate with internal and external stakeholders. Preparation of clinical trial application dossier for HA submissions, and other competent authorities (e.g. medical devices, communication devices import license). Support to download study documents from vault rim as per CTA document package. Tracking study specific events and/or documents and maintaining appropriate tools and logs.Ability to work in changing environment to be agile and proactively find efficient ways of doing things. Ability to multitask and deliver within agreed Timelines. Environment with patient-cantered business approach.

About the department

The Clinical Trial Administration department at Novo Nordisk is located in Bangalore. We are committed to compliance with Novo Nordisk principles and internal legal laws, as well as local regulations in India and other affiliates. Our team works collaboratively to ensure the confidentiality of company and patient information while driving forward life-changing research. With occasional opportunities for international travel, our department offers a dynamic and rewarding work environment.



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