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Senior Clinical Project Specialist - Ssu

Novotech - Sydney, NSW

Health, Medical & Pharmaceutical
Source: uWorkin


Novotech is internationally recognized as the leading regional full-service contract research organization (CRO) in Asia-Pacific providing clinical development services across all clinical trial phases and therapeutic areas, including an in-house and integrated global product development and regulatory affairs consultancy, BioDesk.

Working in a fast paced and adaptable environment, we set a high benchmark for clinical trial operations by listening carefully, allocating Asia Pacific’s best people and talent, and leveraging best in class platforms, technology, systems and processes to meet our client’s clinical program goals and ultimately improve patient lives.

Our people are critical in meeting organisational and client’s objectives and we place a strong emphasis on creating an inclusive, collaborative, transparent and collegiate work environment where everyone is supported to be the best they can be. We support our employees with financial assistance to enable flexible working arrangements, paid parental leave for primary and secondary careers, and regular training, learning, and international knowledge-sharing opportunities.

The Position

Several positions are currently available in Australia . As the CPS Start Up specialist, you will be responsible for:

  • Assisting Project Management with planning and logistics of site start up activities
  • Working independently to set up sites and drive the site start up process including direct point of contact for site team during start up phase
  • Responsible for all site start up activities from feasibility to site activation including but not limited to IRB/IEC, HA submissions and approvals, contract and budget negotiations, ICF development, generation and collection of essential documents
  • Support trial sites in meeting IRB/IEC, HA, local institutional timelines and proactively inform the PM and project team of local requirements and updates

Minimum Qualifications & Experience
  • Tertiary qualifications in clinical or life sciences related field (relevant experience/qualifications in similar professions may also be considered)
  • Solid knowledge of GCP, national and international regulations and previous clinical site/ CRO/Pharma experience is essential
  • Familiar with the current IRB/IEC and HA requirements, including review and approval processes, and document requirements for submissions
  • Experience assisting clinical sites with IRB/IEC and local institution submissions
  • Some experience with budget and CTRA negotiations with sites and client/CRO would be desirable
  • Experience drafting essential documents required for site activation
  • Knowledge of ICF development including experience generating Site Specific ICFs
  • Excellent interpersonal and team skills with a genuine commitment to contributing to the development of innovative treatments
  • A strong track record in study start up activities, CTA, CRA, Project Specialist role

Find out more about working at Novotech at: www.novotech-cro.com/careers

Novotech is committed to offering Equal Employment Opportunities (EEO) where everyone has equal access to employment opportunities based on merit, without fear of discrimination or harassment.

Sydney, NSW

Health, Medical & Pharmaceutical


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