Maintain program specific timelines and deliverables, including critical program, financial and communication milestones.Monitor deliverables and timelines to ensure meeting development activities per timeline and proactively communicate risks to the Program Lead
Provide vigorous leadership to the CRO and the Operations team, ensuring that clinical data are collated and critically evaluated at appropriate intervals to provide feedback on project progress and issues in a timely manner to team members and Halozyme management
Assist in the transfer and performance of manufacturing techniques and the development and specification of processing parameters.Act as key contributor in working with CMOs to develop batch records and production specifications
We are seeking a highly motivated individual to join as Sr. Drug Safety Specialist as part of our Drug Safety Operations team.This individual will be responsible for clinical and/or post marketing safety activities, including, but not limited to, communicating/coordinating information with internal Drug Safety personnel.
The Senior Manager, Clinical Operations will be responsible for managing aspects of the operations of an oncology clinical research program, which may involve multiple simultaneous clinical studies of all phases of clinical development.