CBS DT Clinical SME

Our mission starts with improving the lives of patients living with severe diseases. Data and digital technologies are central to how we invent develop and deliver innovative therapies. Within the Global DT Clinical Patient Evidence organization this role plays a critical part in delivering and optimizing digital clinical solutions with a strong focus on Veeva Clinical Vault Cloud platforms. The position combines delivery-focused project leadership with hands-on Veeva Vault subjectmatter expertise supporting the full lifecycle of clinical digital systemsfrom design and implementation through validation enhancement and operational support.

The role contributes directly to transforming how clinical trials are conducted by enabling compliant scalable and patientcentric digital solutions.

MAJOR ACCOUNTABILITIES

1. Digital Clinical Solution Delivery & Project Leadership

Lead and contribute to the delivery enhancement and maintenance of digital clinical platforms across Clinical Operations and Development.

Manage projects across the full solution lifecycle including planning execution risk

management status reporting and stakeholder alignment.

Apply Agile and hybrid delivery methodologies supporting rapid prototyping and iterative delivery where appropriate.

Coordinate with internal IT teams clinical stakeholders and external vendors to ensure cohesive delivery.

2. Veeva Clinical Vault SME Responsibilities

Act as the technical and functional subject-matter expert for assigned Veeva Clinical Vault Domain

Provide technical design input and business analysis ensuring optimal configuration and integration with upstream and downstream systems.

Challenge vendor or project-proposed designs when out of scope or suboptimal and investigate best-fit technical solutions.

Serve as the technical reference point for the Vault domain ensuring technology consistency and best practices.

Perform complex configuration and administrative tasks within Veeva Vault.

Execute end-to-end change requests including impact assessment configuration

testing documentation and deployment.

Support data and document migration activities using tools such as Veeva Vault Loader.

Maintain system documentation technical specifications and operational procedures.

3. Quality Validation & Compliance

Ensure all systems operate in compliance with GxP requirements including GCP and 21 CFR Part 11.

Plan execute write and review validation and test scripts (IQ OQ PQ as applicable).

Collaborate with quality and validation teams to ensure audit-ready documentation and traceability.

Maintain a strong focus on data integrity system reliability and regulatory compliance.

4. Stakeholder Engagement & Knowledge Sharing

Act as a bridge between technical and business stakeholders translating requirements into actionable technical solutions.

Work closely with digital solution owners digital study leads and external providers to ensure shared understanding and execution.

Coach and mentor team members supporting knowledge transfer and adoption of newly implemented features.

Contribute to ideation and continuous improvement initiatives across digital clinical platforms.

Requirements

EDUCATION & QUALIFICATION

A bachelors degree in computer science or field relevant to this Job Description

5 years of experience in IT project management Agile delivery or digital solution implementation.

3 years experience in the pharmaceutical industry within clinical development.

Hands-on experience with Veeva Vault administration support or implementation (minimum 6 months mandatory).

Experience working in GxPregulated environments including system validation.

Experience with SaaS platforms cloud-based systems integrations and interfaces.

Experience with data and document migrations is strongly preferred.

Prior exposure to digital clinical solutions (CTMS eTMF eCOA EDC) is a plus.

Technical & Professional Competencies

Strong expertise in Veeva Clinical Vault (configuration administration deployment).

Understanding of GxP validation testing and quality processes.

Knowledge of REST APIs web services and system integrations.

Strong project management skills (planning tracking reporting).

Ability to write clear structured test scripts and technical documentation.

Advanced Microsoft Office skills.

Behavioural Competencies

Deliveryfocused proactive and solutionoriented.

Strong communicator able to engage with both technical and business stakeholders.

Comfortable working independently and within globally distributed teams.

Able to challenge constructively manage ambiguity and adapt to changing priorities.

High attention to detail with a commitment to quality and patient impact.