Principal Clinical Data Manager

2 weeks ago

Sydney, New South Wales, Australia Novotech Asia Full time

**About the role**

The Principal Clinical Data Manager's role is to control all aspects of data management and to ensure compliance with Good Clinical Data Management Practices

**Responsibilities**
- Participate in project meetings and client meetings as Subject Matter Expert for Clinical Data Management providing advice on all aspects of processes, systems and tools in view of client's business objectives, regulatory requirements and Novotech best practices.
- Contribute to protocol development or review client's protocol in terms of schedule of assessments, consistency with assessments' descriptions and internal company standards of the corresponding CRFs
- Support CDM staff with complex CDM study requirements throughout the entire study lifecycle, from protocol development to database lock and decommissioning
- Participate in industry forums (conferences, professional association committee work etc.) and providing training on CDM related topics to Biometrics

**Minimum Qualifications & Experience**:

- Must be a graduate in a clinical or life sciences related field.
- Extensive experience in Clinical Data Management including working in a Senior position in the pharmaceutical or CRO industry
- Excellent understanding of regulations applicable to the CDM area as well as Good Data Management Practices and regulations regarding Electronic Data Capture (EDC) systems and validation

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 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.

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