Senior Manager

Senior Manager focuses on contributes and drives ongoing process improvement initiatives.

What the role involves

• Contributes and drives ongoing process improvement initiatives.
• Monitors progress for site activation and monitoring visits and acts on any deviations from plan.
• Ensure clinical project audit and inspection readiness through the study lifecycle.
• Contributes to clinical study report writing.
• Recommends and participates in cross-functional and departmental process improvement initiatives.
• Support oversight of unmasked clinical monitoring.

Skills and requirements

• Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors.
• Supports internal audit and external inspection activities and contributes to CAPAs as required.
• Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents.
• In order to be considered qualified, a minimum of a Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience.

Confirmed role details

• This role is not eligible fully remote.
• Be Onsite in one of our locations.

Candidate fit

• Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan.

Additional role context

• Assigns tasks to Clinical Study Management staff and supports their deliverables.
• May require 25% travel.
• Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC.