Description:
Company Information:

Breakthrough Careers!
A career at Millennium: The Takeda Oncology Company comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality.

Position Summary:

Manages all aspects of business process development and associated training within the Clinical Organization; Acts as business lead for Clinical Operations technology initiatives; Oversees clinical central files and ensures files are maintained in an audit-ready condition

Duties and Responsibilities:

. Designs and manages a Clinical Operations business process management program which includes SOP and work practice management, assessment and assurance of adherence to standard processes, assessment of staff skill levels and training needs and overall process training infrastructure
. Provides staff mentoring, support, and training for Clinical Operations organization
. Develops, maintains and distributes tools and processes in support of the clinical training program
. Oversees Clinical Central Files function and systems; evaluates and improves the efficiency of processes and tools related to clinical central files; manages central files staff members
. Acts as Business lead for Clinical Operations technology implementations and associated process changes
. Works in close accord with Clinical Quality Standards Quality Assurance and is the Clinical Operations Organization liaison to the CQSQA
. In collaboration with CQSQA, responsible for responses to internal and external audits and implementation of Corrective Action Plans; manages SOP deviation documentation process

Qualifications:

Experience: BS degree with 8+ years of clinical operations experience; 2+ years in a process management, training and/or quality-related position preferred; demonstrated competence as a manager/leader are preferred

Other:
. Solid understanding of US CFT, GCP, ICH and the clinical development process
. Understanding and experience with global regulatory environment is desirable
. Self-starter with demonstrated success working independently
. Self-motivated with comfort working on high performance teams
. Excellent written and verbal skills
. Proficiency in computer applications such as Excel, Word and PowerPoint