Project Manager, Adaptive Clinical Trial Technologies
With operations in 35+ nations and ~27,000 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 one of the largest influenza vaccine companies 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!
• Act as primary contact for clinical trial technology utilized in project(s), working closely with the study teams and vendor project leadership to achieve study goals.
• Responsible for overall management and execution of the technology for the project(s) and coordination of all related activities on a study team.
• Supports ensuring vendor compliance through the CSL Audit Process to ensure that the vendor has the appropriate Quality Management, adequate planning, and resourcing in place to support CSL Projects.
• Interpret the study protocols to assess all possible requirements for technology utilized in the project(s), in addition to those specified during the relevant study team meetings.
• Responsible for supporting developing, reviewing, and approving of project related documentation for the technology utilized during the course of the Project Lifecycle.
• Guide the study team in the development of the specifications and validation plan for the clinical trial technology-paying specific attention to all the project deliverables.
• Responsible for ensuring that the vendor(s) maintains high quality service and on time delivery of data and technical project(s) outputs for the customer.
• Conduct periodic status checkpoints with vendors and study teams to assess progress against the plan. Review status reports on all technical project activities and issues (as required).
• Conduct Lessons Learned to continue to improve processes for clinical trial technology implementation.
• Educated to BA or BS Degree level
• Experience in a Project Management role OR equivalent, ideally related to the pharmaceutical or clinical research industry
• 2-3 years experience at another sponsor or vendor in a role supporting implementation of clinical trial technologies (eCOA, eConsent, biosensors, etc.)
• Experience/understanding of the clinical research environment and GCP principles is preferred
• Organized, good time management and attention to detail is critical