CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.

With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired 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, CSL Plasma, CSL Seqirus and CSL Vifor. 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.

• You will provide 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. Accountable for all clinical program or functional deliverables. These responsibilities include Study Operations, Business Operations and Compliance.
• Ensure all activities that support the TA model are planned following the TA strategy, appropriate international regulatory standards, and within the agreed timeframe and budget.
• Help negotiate CDAs, contractual terms, rate cards, and other contractual items with all vendors that support the TA model. Guide ownership of all deliverables through 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.
• You will develop or help develop the processes (e.g. eTMF) and standards to allow inspection readiness of all clinical studies and ensuring compliance with quality standards. Manage internal quality processes following defined standards to ensure that quality is built in upfront and checks are integrated into study activities.

• Bachelor's degree , or equivalent, in Science related discipline
• 7+ years experience working in a Clinical Operations environment is required.
• Global Clinical Operations experience is important.
• Experience should include 2 years of on-site monitoring and clinical research experience or education.
• Global Clinical Operations experience, clinical trial system experience and ICH GCPknowledge is important

• Medical, Dental Vision
• 401K
• Paid time Off