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
subject‑matter expertise, supporting the full lifecycle of clinical digital
systems—from 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 patient‑centric 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 bachelor’s
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 GxP‑regulated
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

• Delivery‑focused, proactive, and solution‑oriented.

• 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.