Clinical Lead

1 day ago

Sydney, New South Wales, Australia Novotech Asia Full time

**Brief Position Description**:
The Clinical Lead (CL) and Senior Clinical Lead provides direction and guidance to multi-country clinical teams in assigned project(s), coordinates site management and monitoring activities, and provides operational leadership for clinical teams to achieve project deliverables.

**Minimum Qualifications & Experience**:

- Graduate in a clinical or life-science related field.
- Must have working experience in managing clinical operations deliverables & leading the CRA team across multi-region in global/regional studies
- Need to demonstrate the working experiences in clinical study deliverables, study quality & system compliance management and creation of study plans, understanding of vendor management
- Must have the ability to meet deadlines in a fast and dynamic environment.
- Good communication skills and fluency in both verbal and written English

**Responsibilities:
- Lead site identification and site selection activities.
- Prepare for and attend investigator meetings; may present materials.
- Review Monitoring Visit Reports (MVR) and follow-up letters for compliance with ICH-GCP and the CMP; provide final approved documents to Sponsor as required and track report metrics in CTMS.
- Ensure appropriate issue escalation and tracking of these to resolution, proactive identification of areas of risk, and develop risk management strategies.
- Assist PM with response to audit findings and assist the clinical team with completion of any CAPA review and documentation.
- Work with PM to manage clinical resources to ensure monitoring activities are within budget and notify the PM of any changes required or changes in scope.

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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