The position will involve contributing to the further development and optimisation of CTIS, including in preparation for upcoming regulatory initiatives such as the Biotech Act. Additionally, the position may also require:

•  supporting the design and implementation of activities under the ACT EU programme, in relation to CTIS business intelligence;

•  contributing to communication and change management activities related to CTIS and ACT EU; 

•  providing data analysis and insights to support EMA and the European Medicines Regulatory Network (EMRN);

•  strengthening support to the CTCG and to large multinational clinical trials, including initiatives such as FAST-EU and the pre-CTA consolidated advice process.

In this role you will

Working within the EMA Data Analytics and Methods Task Force you will be part of multidisciplinary teams at EMA and across the National Competent Authorities and European Commission. You will contribute to strengthening and transforming the European clinical trials environment, supporting key regulatory, scientific, and operational activities. These activities are especially focused on supporting the oversight as well as contributing to the implementation of the revised CTR by the BTA by advising and supporting the development of the Clinical Trial Information System (CTIS). 

Depending on the specific position, you may:

• interact with different stakeholders (EU member States, European Commission, sponsor representatives, IT providers, EMA legal service) to provide business input in the following CTIS project/programme activities:
  • Analysis & design (AD) session and raise any issues that may arise during the A&D session
  • Review of the functional specifications related to CTIS development
  • Verify business validations (testing of CTIS) and escalate any issues that may arise
  • Support development of CTIS training material as subject matter expert
  • Provide input and testing for AI related enhancements in CTIS;
• provide responses to external queries on CTIS related matters;
• support communication, stakeholder engagement, and change management activities to promote effective use of CTIS, the upcoming implementation of the Biotech Act and broader ACT EU initiatives;
• conduct data analysis to inform stakeholder needs and support decision-making across EMA and the EMRN.

Link the full role description of the Scientific Officer outlining generic duties and responsibilities.

Apply if you fulfil these eligibility criteria

To be eligible for consideration for this position, you are required to meet the following general and specific eligibility conditions:

General conditions:

1.  Enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein, or Norway;

2.  Have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2);

3.  Have fulfilled any obligations imposed by applicable laws concerning military service.

Specific condition: 

1.  A level of education which corresponds to completed university studies of at least three years in Life Science (e.g. biology, chemistry, biochemistry, pharmacy, medicine), attested by a diploma that must have been obtained by the closing date of this vacancy notice.

General Condition 1 and Specific Condition 1 will be verified firstly based on the application form and then you will be required to provide documentary evidence at the interview stage. Failure to present these documents may result in the disqualification from the selection procedure. 

Only eligible candidates will be assessed by the Selection Committee.

You will need

Experience

• A minimum of 2 years of experience in the fields of research, development, manufacture, regulation or authorisation of medicines or clinical trials;
• Experience in translating Business requirements into IT Specifications and validating those requirements;
• Experience in information analysis and reporting on scientific/regulatory matters;

Skills & Knowledge

• Excellent Prioritising and Organisational skills;

Competencies you need to have:

Sub-family competencies  

Regulatory frameworks & strategy  Basic

Scientific evidence management  Basic

Scientific product lifecycle and procedure management  Basic

Applied knowledge management  Basic

Grade competencies

Adaptability and agility  Intermediate

Coping with pressures and setbacks  Intermediate

Analysing and problem solving  Intermediate

Core competencies

Ethics and integrity  Intermediate

Team collaboration  Intermediate

Customer centricity  Intermediate

Results orientation  Intermediate

Communication  Intermediate

Cross-cultural sensitivity  Intermediate

Continuous learning and self-development  Basic

For more information about definitions of competencies and associated proficiency levels, please refer to the EMA Competency Framework.

These are considered as Nice to Have

Education

• Masters in a relevant field of study (Medicine or Life sciences);
• Completed PhD or master’s degree in one of the university degrees required for eligibility.

Experience

• In data management and data analysis;
• In testing and validation of AI-enabled solutions or knowledge of Digital/AI enabled systems;
• In regulatory affairs on EU-wide or national procedures or other work on the regulation of medicines;
• In information analysis and reporting on scientific/regulatory matters;
• Clinical experience in a therapeutic field;
• In working for a multinational organisation and managing multiple international stakeholders;
• Nonclinical experience in a Good Laboratory Practice (GLP) laboratory.
• In coordination of research projects;
• In working in a regulatory environment related to the evaluation of medicines or interacting with regulatory agencies;
• In delivering, implementing and using data analytics solutions which include Artificial Intelligence components;
• In data analytics frameworks based on cloud technologies, with tools used in analytics and data visualisation such as R, Python. Power BI or Tableau.
• Using statistical software (for instance R, SAS, etc.) and programming languages used in analytics (for instance SQL, PL-SQL, Python, R, etc.);
• Experience with Data visualisation and usage of data visualisation tools (for instance Tableau, R Shiny, Oracle BI, Power BI, etc.);
• Knowledge of data collection and practices with data analysis tools;

Position Summary

• To lead and be accountable for end-to-end delivery of the assigned Therapeutic Area (TA) portfolio within RCO Japan, by directing both the Clinical Trial Management (CTM) and Clinical Research Associate (CRA)/Site Management line functions as a single, integrated operating model.
• Ensure delivery of clinical operations effectiveness across the TA portfolio in RCO Japan, in alignment with global R&D and local business priorities and the RCO Japan Book of Work.
• Serve as a member of the RCO Japan Leadership Team, reporting to the RCO Japan Head, and contribute to RCO Japan-wide strategy, resourcing decisions, and quality culture.

Duties/Responsibilities

Key Responsibilities

Portfolio & Operational Leadership

• Own end-to-end accountability for clinical trial delivery across the assigned TA portfolio, integrating the CTM (trial management) and CRA (site management) functions into a single accountable operating model.
• Execute the assigned TA portfolio in line with the RCO Japan Book of Work, ensuring timely study start-up and that target subject recruitment numbers and database lock timelines are met.
• Direct and align CTM Line Managers and CRA Line Managers to ensure consistent resourcing, workload evaluations, and study assignments in alignment with R&D and local priorities.
• Make decisions on portfolio-level resource allocation, study prioritization, and risk mitigation strategies.
• Accountable for portfolio-level study metrics (enrollment, quality, timeline, budget) and team performance across both CTM and CRA functions.
• Approve study fee funds and payments within grant of authority for the portfolio.
• Ensure implementation of Corrective Action/Preventive Action (CAPA) and provide necessary resources/tools at the portfolio level.

Strategic Partnership & Organizational Leadership

• Serve as the senior RCO Japan representative for the assigned TA portfolio, building trusted partnerships with CD TA Head(s), GRS TA Head(s), Medical, GPV and HR to align on Japan strategy and delivery.
• Lead strategic partnerships with internal and external stakeholders to advance clinical trial innovation and operational excellence across the portfolio.
• Discuss, decide and coordinate roles & responsibilities across the CTM and CRA organizations; build and continuously improve the operating structure for the portfolio.
• Represent RCO in local affiliate leadership discussions and external forums as needed.

Compliance & Quality

• Take ultimate accountability for GCP, ICH Guidelines and local regulatory compliance across the portfolio's clinical trial delivery.
• Support Health Authority inspections, pre-inspection activities, and audit preparation for the portfolio.
• Assess and escalate significant compliance/quality risks, and build consensus on risk minimization or mitigation plans with relevant stakeholders.
• Support a GDO Quality Culture, collaborating with the GDO Global Clinical Compliance team and the GQ Clinical Trial and Safety group as needed.

Talent Management

• As a role model, ensure CTM Line Managers and CRA Line Managers fulfill their supervisory responsibilities properly, and provide them with necessary support after sharing all direct reports' responsibilities.
• Provide expert advice, coaching and skill development to Line Managers to enable them to fulfill their competency effectively.
• Manage hiring, performance management, and succession planning for Line Managers and, through them, the broader CTM/CRA organization.
• Participate in performance calibration and talent review meetings for the portfolio.
• Foster a culture that values diversity of thought, promotes integrity, and creates an atmosphere that supports coaching and fosters accountability across the organization.

Stakeholder Engagement

• Collaborate with cross-functional stakeholders (local Medical, Clinical Development, RDSP, DQS, GRS, PS, Commercial, Human Resources, Legal and Compliance) to ensure integrated, portfolio-wide delivery, consistent with RCO Japan's broader matrix relationships.
• Ensure effective external partnerships with study sites, investigators, trade associations, and local health authorities (e.g., PMDA) relevant to the portfolio.
• Spend approximately 10-20% of working time in the field, visiting clinical trial sites and operational KOLs, to build and maintain strong relationships with key sites and investigators.

Digital, AI & Data-Driven Operations

• Leverage digital platforms and data analytics across the CTM and CRA functions to optimize resource allocation, monitor portfolio-level study progress, and support decision-making.
• Actively utilize AI tools and applications across the CTM and CRA functions to drive efficiency, generate insights, and enhance quality of decision-making, while championing a continuous learning mindset and adaptability to evolving AI capabilities within the organization.

Reporting Relationship

• Report to Direct Supervisor: Senior Director, Clinical Operations (RCO Japan Head).
• Supervisory Responsibility
  • Direct line reporting responsibility for RCO Line Manager of Clinical Trial Manager and RCO Line Manager of CRA roles within the assigned Therapeutic Area portfolio.

Qualifications

• Minimum of 12 years pharmaceutical industry experience in Clinical Research including significant leadership experience in clinical trial operations.
• Demonstrated experience leading people leaders/managers (i.e., managing managers) across both trial management (CTM) and site management (CRA) disciplines, or equivalent cross-functional leadership experience.
• Significant experience in the planning, conduct and management of clinical programs (Phase I-IV).
• Prior clinical trial management and/or monitoring experience required.
• Proven track record of strategic leadership, cross-functional collaboration, and external partnership management.
• Demonstrated ability to make final decisions on portfolio-level strategy, resourcing, and risk mitigation.
• Experience with Health Authority inspections and audits.
• In depth understanding of GCP, ICH Guidelines and other local guidance, regulation and codes of practice related to Clinical Research.
• Demonstrated organizational and planning skills and independent decision-making ability.
• Strong organization and time management skills and ability to effectively manage multiple competing priorities across a multi-disciplinary portfolio.
• Outstanding interpersonal, oral and written communication skills to influence, inform or guide others; ability to build trusted partnerships with senior internal and external stakeholders.
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