Senior Manager, Integrated Clinical Trial Data Process Excellence and Delivery

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The Senior Manager, Process Excellence and Delivery supports the strategy to develop and maintain quality Global Integrated Clinical Trial Data Services (GICTDS) function processes for clinical trial data delivery, study reporting, and inspection readiness. They define processes to ensure complete, accurate, high quality, regulatory compliant data in support of publications and regulatory submissions.

In partnership with functional stakeholders and with Global Development Compliance, they contribute to and may lead within-function and cross-function process definition, training, and change management activities to successfully deliver the functional operational strategy.

A CCOUNTABILITIES:

Support and may lead process design and governance for any of the following GICTDS functions: Clinical Data Management, Clinical Data Engineering, Clinical Data Standards, Clinical Trial Tools and Technologies, Risk Based Quality Management, Medical Writing, Information Management and Operational Systems, and Emerging Priorities and Innovation.

Partner with Global Development Compliance (GDC) GCP Process Excellence to develop and implement these processes.

Serve as functional process lead or business process owner for a defined set of processes. Includes liaising with GDC on continuous process improvement, serving as process expert for end-users, and serving as point of contact for Quality related activities/initiatives.

Collaborate with key stakeholders such as functional heads, business process owners, and clinical data system owners and product teams to support the implementation and maintenance of effective process(es) across the Takeda Network.

Contribute to decision making to determine and clarify roles and responsibilities across functions and to determine how process responsibilities will be executed using clinical trial systems and technologies. 

Contribute to development of new processes and technologies in compliance with quality standards (including ICH GCP, local regulations, and Takeda SOPs). 

Monitor metrics and feedback from the global network and users to ensure the health of the process and performance against measures that are aligned with the organization strategies. 

In partnership with GDC GCP Process Excellence, collaborate with both asset teams and leaders within Global Development Operations (GDO) to identify opportunities for improvement in Takeda's clinical trial data delivery & study reporting processes including optimizing roles and responsibilities cross-functionally.

Support Takeda's clinical trial data delivery & study reporting process strategy based on external and internal perspectives to achieve GICTDS short-term and long-term goals.

Develop solutions to complex problems which require the regular use of ingenuity and innovation. Ensures solutions are consistent with GICTDS objectives.

EDUCATION AND EXPERIENCE:

Bachelor's Degree or international equivalent required; Life Sciences preferred. 

6 or more years’ experience in the pharmaceutical industry or clinical research organization, including clinical data management/clinical trial data delivery & study reporting.

6 or more years of operational experience in clinical data management/EDC build and programming, IRT/eCOA implementation and management, data transfers/ingestion, centralized monitoring, and/or regulatory submission experience. 

Understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, data management plans, clinical study reports) and processes.

Understanding of clinical trial technologies, including EDC, IRT, eCOA, digital wearable tools, CTMS, TMF systems, centralized monitoring systems, and clinical study report generation tools.

Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.

Demonstrated matrix leadership and communication skills.

Knowledge of FDA and ICH-GCP guidelines for conducting clinical research.

Global/international experience preferred, including the ability to collaborate with team members in other locations.

Takeda Compensation and Benefits SummaryWe understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.For Location:Massachusetts - VirtualU.S. Base Salary Range:133,000.00 - 209,000.00The 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-term incentives. 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.EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob ExemptYes#LI-Remote