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Senior Clinical Data Associate

Novotech Clinical Research India
Full-time
On-site
Australia
Description

About the Role

The Senior Clinical Data Associate acts as the primary point of contact for all external data matters for the study team and is responsible for the timely delivery of quality outputs following all applicable regulatory, compliance, best practice and operational procedures.

Responsibilities:

  • Scope external study data requirements and effort for projects and project manage all external data related activities across multiple projects.
  • Provide expert advice on the transfer and expected formats of data transfer files.
  • Provide technological expertise and guidance on the best methods for handling laboratory data and other external data.
  • Create and maintain data transfer agreements. Maintain study documentation within project files as appropriate.
  • Act as primary contact and study representative to third party data providers. Effectively communicate transfer requirements and project timelines to various stakeholders. Identify and communicate project risks.
  • Ensure data integrity is maintained by implementing appropriate data controls for masked data and ensure delivery of timely data transfers and undertake quality reviews and testing activities.
  • Conduct external data reconciliation using available technologies and processes and raise queries to external data providers and track queries to successful resolution.

Experience and Qualifications:

  • Graduate in information science or life science related field, or similar 
  • Relevant experience /qualifications in allied professions may also be considered. 
  • Preferably at least four years experience in data management in a pharmaceutical company, CRO or EDC software provider.

Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. 

Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. 

We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. 

We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.



Qualifications

Minimum Qualifications & Experience

Graduate in information science or life science related field, or similar. More than four years’ experience in a Senior Clinical Data Manager/Clinical Data Programmer /Laboratory Data Specialist role in a pharmaceutical company, CRO or EDC software provider.