Clinical Applications SME for Digital Technology (DT) Clinical Analytics
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Contract
Posted 23d ago
~40 hrs/week
Responsibilities
Manage and support GxP and non-GxP clinical applications and data analysis platforms. Coordinate system updates, validation activities, and lead digital technology projects in collaboration with cross-functional stakeholders.
Requirements
Requires extensive experience in Pharma IT and project management within highly regulated GxP environments. Must be proficient in regulatory standards like GAMP5 and 21 CFR Part 11 with strong communication skills.
Full job description
This is a remote position.
The consultant will join the Clinical Development domain, working in close collaboration with stakeholders from Digital Technology (IT), Clinical Development teams, and external vendors.
The role focuses on implementing, maintaining, and ensuring compliance of technology solutions used in Clinical Analytics, within a highly regulated (GxP) pharmaceutical environment.
The position combines technical application management and project management responsibilities, within a complex and cross-functional organization.
Typical Day
Managing and supporting clinical applications (GxP and non-GxP systems)
Maintaining and operating clinical data analysis platforms (including R Shiny apps and dashboards)
Handling system updates, changes, and releases
Supporting validation activities with IT Compliance and QA teams
Managing user access and incidents
Coordinating testing, training, and acceptance activities
Leading or contributing to DT projects (planning, reporting, communication)
Collaborating daily with cross-functional stakeholders and external vendors
Requirements
Years of Experience
Proven experience in IT and project management
Strong experience in clinical development / Pharma IT environments (senior-level profile expected)
Must Have
Strong relevant professional background (key selection criteria from manager)
Experience in GxP environments and regulatory standards (GAMP5, V-model, 21 CFR Part 11, Data Integrity)
Experience in clinical development systems / Health IT
IT services specialists since 1996. We enable success through simplicity, flexibility, and innovation.
Industry
IT Services and IT Consulting
Company size
201-500 employees
Founded
1996
Headquarters
Lausanne
LinkedIn followers
25,728
NextLink is a global leader and the fastest growing next-generation provider of IT, BPO and digital services. We are a team of experienced IT practitioners, outstanding engineers, and innovative team members with a deep-rooted passion for automation. We strive to deliver the best possible solutions using digital technologies and targeted talent sourcing. We enable man-machine collaboration, solve complex business problems, and combine human creativity and intellect with powerful algorithms.
Our Vision:
To be the most reliable one-stop-shop for high quality technology services delivered within a collaborative empowerment culture.
Our Values:
• Customer Focus – Our customers are at the centre of everything we do.
• Passion – We are passionate about delivering innovative, high quality services to our customers and our teams.
• Collaboration – We work together with our customers, our partners and in our organisation to always achieve the best results. Together we are stronger.
• Empowerment – We empower and enable our people to make things happen.
• Flexibility – We are flexible and adaptable in our ways of thinking and working. We make the impossible possible.
An Overview of our Services:
TECHNOLOGY:
• Enterprise Application Services
• SAP
• Microsoft
• Salesforce
• ServiceNow
• Infrastructure Services
• AWS
• Oracle
CONSULTING:
• Technology Consulting
• Enterprise Application Transformation Services
• Mobility and Workplace Services
OPERATIONS:
• Targeted talent sourcing
• Business Process Services
DIGITAL TRANSFORMATION:
• Mobility
• Data Sciences & Analytics
• Cloud
• Internet of Things
• Machine Learning Solutions
• Robotics Process Automation
• Artificial Intelligence
• Blockchain
• Digital Health Solutions
IT services specialists since 1996. We enable success through simplicity, flexibility, and innovation.
Industry
IT Services and IT Consulting
Company size
201-500 employees
Founded
1996
Headquarters
Lausanne
LinkedIn followers
25,728
NextLink is a global leader and the fastest growing next-generation provider of IT, BPO and digital services. We are a team of experienced IT practitioners, outstanding engineers, and innovative team members with a deep-rooted passion for automation. We strive to deliver the best possible solutions using digital technologies and targeted talent sourcing. We enable man-machine collaboration, solve complex business problems, and combine human creativity and intellect with powerful algorithms.
Our Vision:
To be the most reliable one-stop-shop for high quality technology services delivered within a collaborative empowerment culture.
Our Values:
• Customer Focus – Our customers are at the centre of everything we do.
• Passion – We are passionate about delivering innovative, high quality services to our customers and our teams.
• Collaboration – We work together with our customers, our partners and in our organisation to always achieve the best results. Together we are stronger.
• Empowerment – We empower and enable our people to make things happen.
• Flexibility – We are flexible and adaptable in our ways of thinking and working. We make the impossible possible.
An Overview of our Services:
TECHNOLOGY:
• Enterprise Application Services
• SAP
• Microsoft
• Salesforce
• ServiceNow
• Infrastructure Services
• AWS
• Oracle
CONSULTING:
• Technology Consulting
• Enterprise Application Transformation Services
• Mobility and Workplace Services
OPERATIONS:
• Targeted talent sourcing
• Business Process Services
DIGITAL TRANSFORMATION:
• Mobility
• Data Sciences & Analytics
• Cloud
• Internet of Things
• Machine Learning Solutions
• Robotics Process Automation
• Artificial Intelligence
• Blockchain
• Digital Health Solutions