Study Plan & Feasibility Spec.
With operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
Responsibilities: • Provides support to a clinical study in a designated Therapeutic Area (TA) or is a team member in a function that supports the delivery of the portfolio. This includes all functions within Clinical Development Operations. • Ensure all study level activities that support the TA model are successfully delivered based on the requirements of the TA strategy, appropriate international regulatory standards, and within the agreed timeframe and budget. This includes study, data, and business operations as well as compliance, • May support the negotiation of CDAs, contractual terms, rate cards, and other contractual items with all vendors that support the TA model. • Follow the processes, systems (e.g. eTMF, CTMS, EDC, GFIS, etc.) and standards to enable inspection readiness of all clinical studies as well as ensuring compliance with quality standards. Support internal quality processes in line with defined standards to ensure that quality is built in upfront and checks are appropriately integrated into study activities. • Under general supervision, provide input to implementing processes for clinical trial activities. • For business processes and technologies, liaise with study teams to facilitate knowledge and use of tools and processes. Qualifications: • Bachelor degree or equivalent • 3+ years' relevant clinical research (or related) experience within the pharmaceutical industry. • A solid understanding of the drug development process, and specifically, each step within the clinical trial process. • Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process. Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.