Job Description

At our heart we are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity, and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, sexual orientation, race, color, ethnic or social origin, or disability.

Our team is growing and for this we need bright minds with creativity and flexibility - what talent do you have?

OBJECTIVE

• Responsible for the strategic oversight and continuous improvement of Trial Master File (TMF) and Clinical Trial Management System (CTMS) processes, acting as the functional owner and subject matter expert.
• Evaluate process changes, driving innovation and automation, and collaborating with cross-functional teams to implement technology-driven solutions that enhance operational efficiency and quality.
• Maintain a constant state of audit and inspection readiness, including accountability for inspection activities and follow-up.

CORE ELEMENTS RELATED TO THIS ROLE

• This role serves as the key representative of the VBU for clinical study documentation and management of systems, with a strong focus on ensuring inspection readiness and regulatory compliance.

DIMENSIONS AND ASPECTS

• As VBU representative for the study documentation and management of related processes and systems:

  • Serve as the functional owner of Trial Master File (TMF) and Clinical Trial Management System (CTMS) related processes, ensuring they are inspection ready.
  • Accountable for TMF and Clinical Documentation standard operating procedures, processes, best practices and tools for clinical trial documentation and its lifecycle management ensuring compliance with the evolving regulatory requirements, industry trends, technological advancement and business needs.
  • Development and ownership of lifecycle of VBU document standards (e.g. VBU specific TMF Plan and TMF Index templates), process documents (e.g. SOP, job aids, guidance documents for systems and process) and tools; collaborate in partnership with VBU functions, Pharma R&D and CRO as appropriate.
  • Drive strategy for business processes related to clinical research documents (e.g. TMF document processing, wet ink process and TMF quality control, TMF archiving) and document management systems (DMS) such as Veeva eTMF.
  • Evaluate how changes in related processes affect VBU, providing insights and recommendations to mitigate risks, optimize outcomes, and maintain a state of continuous inspection readiness. Responsible for end-end change management.
  • Drive communication, exchange of ideas & feedback on process effectiveness, improvement opportunities, simplification and automation possibilities with internal and external stakeholders, with a focus on sustaining compliance and audit preparedness.
  • Represent VBU for Clinical Documentation and Information related topics in front of CRO Partnership leads to align expectations on systems & processes, where applicable in alignment with Takeda Pharma R&D.

• Identify areas for improvement within existing processes applied to study management. Propose and implement innovative solutions to enhance efficiency, quality, and compliance. Include quantitative descriptions of expected impact, such as reduction in manual effort and improved inspection readiness through applied expertise and technical solutions.

• Work synergistically with Innovation, Technology and e-Systems Solution, DD&T Business Partner, and applicable stakeholders to drive innovation adoption. This includes identifying and implementing innovative solutions that enhance clinical processes and ensure alignment with the overall strategic goals.

• Contribute to the identification of key processes affected by changes in the operating model, ensuring their common understanding:

  • Help the team understand the main changes and explore options to streamline implementation of the new processes while maintaining inspection readiness.
  • Ensure a common understanding of respective processes among all SET members, including those involved in documentation, inspection readiness, and any other applicable study related activities.
  • Promote process literacy and ensure that all SET members are well-versed in the relevant procedures.

• Collaborate closely with the R&D organization to ensure that applicable processes adopted are fit for purpose for Vaccine Clinical Development requirements. When existing processes do not meet these needs, this role will be responsible for assessing and implementing suitable solutions with the appropriate stakeholders and SMEs.

• Act as the accountable person for audits and inspections related to clinical documentation processes and systems, eTMF, CTMS and solutions related processes. Ensure timely and effective follow- up on findings.

• Organize own work assignments, prioritization and capacity.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

• Bachelor degree or equivalent, preferably in life science, clinical research, or related discipline.
• Deep practical knowledge of TMF processes, related standards (e.g. DIA Reference Model) and its quality control.
• Thorough understanding of ICH-GCP quality standards and other relevant regulations; comprehensive knowledge of Good Documentation Practice.
• Fluent knowledge of spoken and written English.
• Minimum 6 years professional experience in document management/business project/process or operations management preferably in the pharmaceutical industry.
• Experience in supporting and/or hosting audit or inspection preparation.
• Knowledge of CRO partnership operating model is a plus.
• Very good self-organization, time management skills, independent and structured way of working.
• Excellent problem-solving and communication skill.
• Proactive mindset, strong analytical skills, and a passion for process excellence in a regulated environment.
• Ability to work remotely and within a team in a matrix organization. Experience in working in an international matrix setting (cross-culturally, globally) and aligning parties without direct authority.
• Strong methodical skills combined with proven ability to efficiently maintain work stream, databases/systems; comfortable in handling/crunching large volume of data, synthesize it into meaningful trends and translate into corresponding action.
• Experience in reviewing/extracting/inter-relating data from multiple data source/systems in a seamless way.
• Advance level of Microsoft Excel and other Microsoft Office tools.
• Strong presentation, writing and interpersonal skills.

Empowering our people to shine

At Takeda, we earn the trust of society and our customers through our values of Takeda-ism: Integrity, Fairness, Honesty, Perseverance. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential. As a global top employer, we offer exciting career paths, promote innovation, and strive for top performance in everything we do. Takeda fosters an inclusive, collaborative, and international work environment where our teams are united by their relentless commitment to our goal of improving people's health and creating a better future for the world.

Diversity, Equality, and Inclusion

Takeda is committed to foster diversity, equality, and inclusion. Hiring decisions are based entirely on qualifications and are made regardless of gender, ethnic origin, religion, sexual orientation, age, or disability.

If you are interested in this opportunity, we look forward to receiving your application via our online tool!

Learn more at takedajobs.com

Locations

Zurich, SwitzerlandCambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time