Senior Clinical Study Manager

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Posted
Aug 29, 2020
Ref
R-118250
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
About CSL

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!

Job Description

• 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 activites 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
• 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.