Senior Manager, Integrated Clinical Trial Data Process Excellence and Delivery

The Fountain Group; Cambridge; Remote; GBP 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a Senior Manager for Process Excellence and Delivery to enhance global processes within their clinical trial data services. This role involves leading critical initiatives to ensure high-quality, regulatory-compliant data delivery and optimizing operational excellence. The ideal candidate will have extensive experience in the pharmaceutical sector, strong leadership skills, and a knack for strategic problem-solving. This is an exciting opportunity to contribute to innovative solutions and drive process improvements in a dynamic environment, making a significant impact on clinical trial success.

Qualifications

• 6+ years in the pharmaceutical or clinical research industry.
• Experience in clinical data delivery and study reporting.

Responsibilities

• Lead end-to-end processes within GICTDS functions.
• Collaborate with clinical system owners to drive harmonized processes.

Skills

Clinical Data Management

EDC Programming

Regulatory Submissions

Communication Skills

Problem Solving

Collaboration Skills

Education

Bachelor's Degree in Life Sciences

Tools

EDC

IRT

eCOA

CTMS

TMF

Job description

Details for the positionare as follows:

• 11-month contract to start with the possibility of extension or conversion depending on performance and budget.
• Rate: $83-90
• Location: Remote

Job Description:
The Senior Manager, Process Excellence and Delivery plays a key role in driving the strategy, development, and continuous improvement of global processes across the Global Integrated Clinical Trial Data Services (GICTDS) function. This role ensures the timely delivery of high-quality, regulatory-compliant clinical trial data to support publications and regulatory submissions, while also advancing Takeda’s inspection readiness and operational excellence.

• Design, lead, and govern end-to-end processes within GICTDS functions, including Clinical Data Management, Data Engineering, Standards, Trial Technologies, Risk-Based Quality Management, Medical Writing, and more.
• Partner with Global Development Compliance (GDC) to define, implement, and refine processes that meet ICH GCP, local regulatory, and internal SOP requirements.
• Act as a process lead or delegate business process owner, serving as a subject matter expert and liaison for quality-related initiatives and continuous process improvement.
• Collaborate cross-functionally with clinical system owners, product teams, and functional heads to drive harmonized processes across the Takeda network.
• Influence decisions on functional roles and responsibilities, ensuring effective execution of trial activities through integrated clinical technologies.
• Monitor process health using metrics and user feedback, identifying areas for improvement and driving actionable change.
• Contribute to the development and deployment of innovative technologies and process solutions aligned with short- and long-term GICTDS objectives.
• Support strategic alignment across GICTDS and Global Development Operations (GDO) by helping identify, prioritize, and implement process optimization opportunities.

Required Skills:

• Bachelor’s degree or international equivalent required; degree in Life Sciences preferred.
• Minimum of 6 years in the pharmaceutical or clinical research industry, including direct experience in clinical data delivery and study reporting.
• Deep operational experience across data management, EDC programming/builds, IRT/eCOA management, centralized monitoring, and regulatory submissions.
• Strong working knowledge of clinical trial documents and regulatory requirements.
• Proficient with clinical trial technologies (e.g., EDC, IRT, eCOA, CTMS, TMF, digital health tools, CSRs, centralized monitoring systems).
• Excellent communication, collaboration, and conflict resolution skills; proven success in matrixed environments.
• Demonstrated ability to solve complex problems using innovation and strategic thinking.
• Global experience strongly preferred; ability to work effectively with cross-cultural and geographically dispersed teams.