Senior Clinical Operations Data Specialist (REMOTE)

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OBJECTIVES/PURPOSE

The overall purpose of this position is to serve as a Senior Clinical Operational Data Specialist to drive process optimization, data governance and technology innovation for trial operations data and systems. The role is accountable for critical activities related to the systems, process, and data governance for clinical trial operational systems including Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF) and numerous other platforms. This includes a significant focus on monitoring overarching data integrity efforts to enable insights and analytics.

Data Governance & Stewardship

• R&D Data Domain Working Group Analyst for Innovation and Data (I&D) including collaborating with cross-functional stakeholders to prepare and facilitate governance meetings; Support management of key decisions are maintained, participate in data cataloguing and monitoring of data quality

• Primary data steward for clinical trial operational systems and/or inputs into R&D systems (e.g., Veeva Vault Clinical, CTMS, Trial Listings Solution, HCP Engagements etc.)

• Participate in the development and monitoring of the operational data quality checks in collaboration with key stakeholders

• Monitor data quality with data owners and external vendors 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

• Participate in the management of trial operations vendor data feeds into relevant Takeda systems and manage data quality checks tools; Work closely with key internal and external stakeholders to maintain data transfer specifications and ensure resolution of any data quality issues identified (as applicable)

Technology

• Lead requirements gathering for trial operational systems (e.g., Veeva Vault Clinical, Nexus, CTMS etc.) and/or serve as a representative to provide inputs into R&D systems

• Work independently with stakeholders to prioritize requirements and is a primary resource on complex issues for trial operations systems

• Advise stakeholders to prioritize requirements and to ensure the solution meets/exceeds expectations.

• Participate in system implementation and enhancements ensuring compliance with system development life cycle and 21 CFR Part 11 requirements (as applicable and in collaboration with IT and QA)

• Troubleshoot system issues and help define enhancements; Work closely business system lead to identify and track business needs and opportunities for future system upgrades

• Lead and participate in the development and delivery of end-user training, access and central support model for GDO managed operational systems and/or inputs into R&D systems (e.g., Veeva Vault Clinical, CTMS, Trial Listings Solution, HCP Engagements etc.)

• Review, assess, and revise current standard operating procedures and/or job aids in support of technology implementations

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

• Manage framework for assessing tracking and managing end user compliance with operational system standards

Other

• Lead 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

• Deliver educational training on centralized HCP engagement process and participate in the development of training materials/job aids

• Serve as a key point of contact for specified functional areas within R&D for HCP engagements including liaising with key stakeholders (e.g., Global/Local Compliance, Legal, Meeting Vendors, CRO partners etc.) on behalf of the function

• Seek opportunities to actively participate in process optimization initiatives; Provide input and identify opportunities to leverage operational data and/or technology to further optimize in support of an outsourced trial operating model including considerations for oversight requirements, predictable trial delivery and industry best practices

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelor’s degree or equivalent
• 3+ years experience in pharmaceutical, project administration and/or administrative.
• Experience with data analytics and clinical operations technologies desired (e.g. Medidata, Oracle, Veeva, Salesforce etc.)
• Experience within clinical trial execution and clinical trial lifecycle
• Experience in process development management, inspection readiness, and clinical trial systems such as TMF and CTMS
• Understanding of system development lifecycle requirements and of US CFR, GCP and ICH
• Knowledge of data stewardship principles and methodologies such as data quality, data governance and master data management
• Experience with Microsoft Office (Excel, Word, PowerPoint, Outlook, TEAMS)
• Strong written/verbal communication skills and presentation and project management skills
• Demonstrated ability to work well within a matrixed environment, and an ability to build solid relationships / make connections across the organization
• Ability to manage and provision large datasets to enable business analysis with a high degree of performance and trust

ADDITIONAL INFORMATION

• Ability to work with wide range of global stakeholders

• Strong adaptive communication skills across multiple levels of the organization
• Excellent written, verbal and project planning skills
• Inspire, motivate and drive results
• Seek input from multiple constituents and stakeholders to drive innovative solutions
• Incorporate feedback and ensure decisions are implemented swiftly
• Negotiate and resolve conflicts in a constructive manner
• Build strong relationships and collaborate effectively with other interfacing Takeda functions
• Self-starter with demonstrated success working independently.
• Self-motivated with comfort working on high performance teams.
• Tolerance of ambiguity and willingness to work through complex issues
• Ability to work with global internal and external partners to achieve desired goals
• Ability to develop solutions to complex issues and challenges
• Promotes team work while working through solutions

Location: Cambridge, MA or 100% Virtual

Base Salary Range: $80,000 - $100,000 based on candidate professional experience level. Employee 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, Company Holidays, Personal & Vacation Days, Student Loan Repayment 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.

This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.

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.

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