Director, Trial Operational Systems Business Lead

at Takeda Pharmaceuticals in Augusta, Maine, United States

Job Description

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Job Description


+ Lead the roadmap development and drive organizational adoption for operational data systems, including for business go-live milestones and new feature rollouts

+ Lead and drive clinical trial operational data stewardship, ensuring quality at all levels of clinical trial delivery operational systems, including both internal and external data systems

+ Lead and evolve clinical trial reporting in support of cross functional stakeholder needs for regulated reporting processes including but not limited to reporting to for regulatory inspections, audits, GDO/R&D Leadership, TAU requests, LOCs R&D Tax reporting

+ Lead and develop a team focused on business administration and business system ownership


Business System Owners

+ Serve as a Business System Owner for transactional clinical trial delivery operational systems (e.g., Veeva Vault Clinical, Nexus, CTMS etc.)

+ Strategize, lead and manage system implementation and enhancements for clinical trial delivery systems, platforms and tools, working closely with business process SMEs and cross-functional stakeholders, ensuring compliance with system development life cycle and 21 CFR Part 11 requirements (as applicable and in collaboration with IT and QA); provide input into the status updates on technology implementations to appropriate management and governance forums

+ In collaboration key stakeholders, support data and documentation requests for audits, regulatory inspections and/or other internal purposes

Business System Administration

+ Develop, lead and maintain robust process for central support model for operational systems, including end user training, user access request including verification of training and access approval for and/or inputs into R&D systems (e.g., Veeva Vault Clinical, CTMS, Trial Listings Solution, HCP Engagements etc.); ensure end user compliance with operational system standards

+ Liaise with IT Technology Leads and Business Stakeholders to resolve system issues and help define enhancements; Work closely business teams, identify and track business needs and opportunities for future system upgrades

+ Provide expertise on clinical trial delivery operational systems across other R&D and Takeda systems

+ In partnership with Process, Training and Digital Strategy, ensure high quality current standard operating procedures and/or job aids are in place to support technology implementations and enhancements

Data Quality and Data Stewardship

+ Lead data stewardship for clinical trial delivery operational data within Takeda operational data systems and/or external inputs into R&D systems

+ Develop and monitor operational data quality checks in collaboration with key stakeholders and data owners to ensure high quality data is available in near real time.

+ Define and embed appropriate quality oversight and governance throughout data program in accordance with R&D policies

+ Develop strategy and manage implementation of a robust data quality process to ensure source system data updates are made in a timely manner to support operational reporting, clinical trial listing regulatory reporting and ensure inspection readiness with both internal and external stakeholders

+ Engage and direct operational data team for all systems and tools within operational data ecosystem


+ Develop, oversee and manage operational data clinical trial delivery reporting, ensuring system roadmap is aligned with business needs to support GxP required regulatory authority trial and activity listing requests (e.g., PSMF Trial Listings, Aggregate Safety Listings, Regulatory Authority Trial Listing etc.)

+ Oversee trial listing report requests for regulatory inspections, audits, GDO Leadership, TAU requests, LOCs R&D Tax reporting, etc.

+ Oversee, lead and manage end to end centralized end user/customer support for specified functional areas within Research & Development (R&D) when engaging an HCP to ensure compliance with Takeda transparency and external reporting requirements including including liaising with key stakeholders (e.g., Global/Local Compliance, Legal, Meeting Vendors, CRO partners etc.) on behalf of supported functions


+ Promote and implement measures to support enable a positive workplace, collaboration, talent development and growth for team

+ Show influential strategic, execution and delivery leadership both within Takeda and outside of Takeda with vendors and partners

+ Act as role model for Takeda’s values

+ Active participation in data quality, governance and operational data system forums within Takeda and external industry groups


+ Bachelor’s Degree or international equivalent required, Life Sciences preferred

+ 10+ years experience in the pharmaceutical industry and/or clinical research organization, including 6+ years in clinical study management, including at least 6 years of line management experience

+ Experience in people leadership, managing global teams and coordinating collaboration with cross-functional teams

+ Strong strategic thinking, planning, execution, and communication skills

+ Global/international experience required, including ability to collaborate with colleagues and staff in other locations

+ Operational experience in clinical development with significant direct exposure to implementation of novel approaches in clinical development

+ Health care business acumen with a comprehensive understanding of the pharmaceutical industry

Base Salary Range: $160-229K. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off. The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

EEO Statement

Takeda 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.


Massachusetts – Virtual

Worker Type


Worker Sub-Type


Time Type

Full time


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Job Posting: JC248865106

Posted On: Sep 30, 2023

Updated On: Nov 01, 2023

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