Senior Manager, Clinical Site Startup and Engagement Process Excellence & Delivery

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

Here, you will be a necessary contributor to our inspiring, bold mission.

GOALS:

• Work closely with the Head of Business Process Excellence & Delivery to develop and execute Clinical Site Startup & Engagement (CSSE) strategic plans, projects, and commitments to drive operational efficiencies and connectivity across CSSE and the Global Development Office (GDO).

• Assist with building new capabilities for the CSSE organization by becoming a Subject Matter Expert (SME) developing new and/or updating defined standard operating practices (SOPs), guidance documents/job aids, tools, and templates to accelerate transformation towards predictive and agile ways of working.
• Work with partners and cross-functional colleagues on an enhanced operating model to ensure consistent delivery of global clinical trials by streamlining processes, enhancing systems, and creating effective tools/templates.
• Support the implementation of process optimization by aligning with business practices set forth by management and continuous improvement initiatives/workstreams becoming a change agent within CSSE, integrating process, and implementing training plans.
• Drive best-in-class process agility and efficiency, by harnessing innovation to automate data collection and documentation, enhancing compliance, improving quality and robustness of CSSE process.
• Ensure crucial strategic and operational cross-organizational issues/projects/initiatives are addressed efficiently and track progress of initiatives, working with teams and leaders across GDO and R&D functions.
• Ensure implementation of new/updated processes and technologies follow quality standards (including ICH, GCP, local regulations and Takeda SOPs)

ACCOUNTABILITIES:

• Support CSSE initiatives to develop and/or update innovative processes and technologies to advance clinical study site startup and reduce critical milestone cycle timelines.
• Collaborate with cross-functional leaders within GDO to identify opportunities for improvement in Takeda's clinical development operations processes including optimizing roles and responsibilities across the Takeda Network.
• Contribute to the development of new processes and technologies in compliance with quality standards (including ICH GCP, local regulations, and Takeda SOPs).
• Support GDO strategic initiatives and processes by representing CSSE on cross-functional teams.
• Support business processes optimization by identifying opportunities for enhancements of core capabilities within CSSE, including process improvements and facilitating best practice sessions.
• Support development and deliver clear, consistent and documented training. 
• Contribute to the development/maintenance of the CSSE on-boarding training and playbook.   
• Maintain guidance documents pertaining to CSSE’s ways of working, including relevant Takeda clinical development processes.  
• Support Takeda's clinical research development operations process strategy based on external and internal perspectives to achieve the Global Development Office's short-term and long-term goals.
• Point of contact for questions and best practices; internal team interface communicating changes and updates as needed.
• Develop solutions to complex problems which require the regular use of ingenuity and innovation. Ensures solutions are consistent with CSSE objectives.

EDUCATION AND EXPERIENCE:

• Bachelor’s Degree or international equivalent required; Life Sciences preferred. Advanced degree is highly desirable.
• 6 or more years’ experience in the pharmaceutical industry and/or clinical research organization, with demonstrable deep understanding of clinical development practices. 
• 6 or more years of direct operational experience in pharmaceutical drug development with direct exposure to clinical development (i.e., study management, study startup, country and site feasibility) in a highly matrix organization across multiple regions.
• Knowledge or FDA and ICH-GCP guidelines for conducting clinical research.
• Global/international experience required, including ability to collaborate with colleagues and staff in other locations.
• Experience in managing global teams, change management and coordinating collaboration with cross-functional teams.
• Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables.
• Strong strategic thinking, planning, execution, and communication skills.
• Health care business acumen with a comprehensive understanding of the pharmaceutical industry.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.