Manager ELN Project Lead and Lab Automation澳洲R-1317983065 CSL Limited
((Write two or three sentences that describe the role. Include information about the team the candidate will work on and to whom he/she/they will report))
- Provides either leadership to, and management of a clinical program in a designated Therapeutic Area (TA) or is a team member within a function that supports the delivery of the portfolio.
- Fully accounable for all clinical program or functional deliverables.
- These functions include Study Operations, Business Operations and Compliance.
- Ensure all activities that support the TA model are successfully planned, implemented and completed in accordance with the TA strategy, appropriate international regulatory standards, and within the agreed timeframe and budget.
- Support the negotiation of CDAs, contractual terms, rate cards, and other contractual items with all vendors that support the TA model. Drive ownership of all deliverables through effective oversight and governance of the vendors.• At a study level, responsible for overall forecasts and management of budgets and resource allocation in collaboration with the Director, ClinOps Lead and the clinical teams.
- Develop or support the development of the processes, systems (e.g. eTMF) and standards to enable inspection readiness of all clinical studies as well as ensuring compliance with quality standards. Manage internal quality processes in line with defined standards to ensure that quality is built in upfront and checks are appropriately integrated into study activities.
- Drive a culture of continuous improvement, always looking for way to reduce cost and timelines, while maintaining the highest level of quality
Your skills and experience
- Bachelor degree , or equivalent, in Science related discipline preferred; Post graduate qualifications in scientific or business related field preferable.
- 7+ years experience working in a Clinical Operations environment is required.
- Global Clinical Operations experience is essential.Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
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