Global Clinical Operations Manager
3 weeks ago
As a key member of SYD Fortrea Australia Pty Ltd's global clinical operations team, you will play a critical role in ensuring the successful execution of local operational clinical trial activities.
The ideal candidate will have a minimum of 1-4 years of experience as a CTL, Project Manager or an equivalent combination of education and experience to successfully perform key responsibilities of the job. This includes executing and overseeing local operational clinical trial activities, with ownership, oversight, and impact on local regulatory and financial compliance.
About the Role
- Key Responsibilities:
- Accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards, and adverse event reporting requirements internally and externally.
- POC for assigned protocols. Proactively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols. Strong collaboration with local CO roles. Forecasts country resource needs. Serves local business needs (signs contracts, manages budgets as delegated).
- Responsible for quality and compliance in assigned protocols in country. Oversees CRAs and CTCs on assigned projects. Oversees training compliance. Performs quality control visits. Reviews Monitoring Visits Reports and escalates performance issues and training needs to functional vendor and internal management as needed.
- Collaborates internally with local PV, Regulatory, GMA/GHH to align on key decisions in countries. Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations.
Requirements
- Mandatory Qualifications:
- Minimum 1-4 years of experience as a CTL, Project Manager or an equivalent combination of education and experience.
- Advanced CRA experience, on-site or in-house. Global clinical project management experience.
- In lieu of the above minimum requirement, candidates with three or more years of relevance clinical research experience in pharmaceutical, CRO, or health care setting will be considered.
About SYD Fortrea Australia Pty Ltd
SYD Fortrea Australia Pty Ltd is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.
Estimated Salary
Around AU$90,000 per annum, depending on experience.
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