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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

Responsiblities

Acting as the primary link between sites and sponsor, you will be responsible for

Several positions are currently available in Australia and the Senior CRA opportunity is a promotional pathway to potentially become an aPM within 12-18 months.

• Assist project management with the development of study tools, clinical trial related documents, project coordination, planning and logistics
• Provide direction and leadership to project CRA’s
• Coordinate & manage clinical monitoring activities from site start up activities to database lock
• Oversee the assignment of appropriate project specific training for CRAs
• Reviews and approves monitoring reports and follow up letters.
• Site management as required and provide trial site updates according to study specific monitoring guidelines
• Support trial sites in meeting project timelines, and proactively inform the PM and team of corrective action, as necessary

Minimum Qualifications & Experience

• Independent Oncology experience would be highly regarded
• 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 a sound understanding of how they apply to you
• Excellent interpersonal and team skills with a genuine commitment to contributing to the development of innovative treatments
• A strong track record of performing visits to sites according to the Clinical Monitoring Plan

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.