Senior Manager, Clinical Trial Tools & Technologies

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:

• Develop strategy for technology selection and deployment across Clinical Studies in alignment with established Takeda SOPs & Policies, and governance models.

• Accountable for system delivery life cycle, including deployment strategies, user training and management.

• Be primary business change agent to ensure adoption of new capabilities and business process.

• Be the first point of contact for Clinical Technology vendors when collaboration is needed to ensure established milestones and deliverables are met with the highest degree of quality.

• Lead study level technology & vendor oversight activities.

• Be a process expert for operational and oversight models.

• Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents.

• Participate in preparing function for submission readiness and may represent Clinical Trial Tools & Technologies (CT3) group in a formal inspection or audit.

• Follow designated strategy for study level technology & deployment and defines vendor oversight activities.

ACCOUNTABILITIES:

• Lead in the deployment of technologies and business process across the CDS organization.
• Establishment and support of business process SOPs.
• Accountable for system delivery life cycle in collaboration with appropriate stakeholders including but not limited to Clinical Operations, Clinical Supplies, IT, and Quality organizations.
• Acts as a primary business change agent to ensure adoption of new capabilities and business process.
• Lead with appropriate stakeholders to establish technology standards and governance models.

Clinical Technology SME in Clinical Study Team accountable for:

• Serving as the first point of contact for implementation of Clinical Technologies like eCOA, IRT, eConsent, Telehealth, Devices or licensing of COA instruments.
• Collaborating with leaders of supported business functions to identify and resolve issues impacting the delivery of clinical trials.
• Being a process expert for operational and oversight models.
• Participating in study level technology vendor oversight activities.

EDUCATION AND EXPERIENCE:

• BS/BA required or MS preferred in a health-related, life science area or technology-related fields.
• 6 or more years drug development experience.
• Project management skills and experience managing implementation of integrations or implementation of clinical technologies like eCOA, IRT, EDC, Medical Devices, and Clinical Data Wearhouse for large drug development programs.
• Working knowledge and understanding of FDA and ICH regulations and industry standards and quality control principles.
• Experience applying System Development Life Cycle (SDLC) and developing strategies to address required changes to clinical trial technologies due to evolving GXP regulations.
• Experience with all phases of drug development.
• Ability to identify new innovative trends in technology to better support clinical trials.
• High complexity at program that include multiple projects and/or platforms.
• Domestic/international travel (5-20%) to other Takeda sites, strategic partners, and therapeutic area events may be required

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.