Senior External Data Specialist FSP

Senior External Data Specialist Clinical Data Management / Vendor Data

The Senior External Data Specialist role is a great opportunity to support Clinical Data Management activities focused on external vendor and laboratory data. You will contribute to ensuring high-quality consistent and compliant data flow across studies working closely with vendors sponsors and internal stakeholders.

You will play a hands-on role across the lifecycle of external data management from planning and setup through to data review reconciliation and issue resolution. This role is ideal for someone with experience in clinical data environments who enjoys working on technically detailed tasks while collaborating in a cross-functional global setting.

What you can expect from us

Office-based or home-based options depending on location
Exposure to global clinical trials and external vendor data management
Highly competitive compensation package with local benefits
Collaborative cross-functional working environment
Opportunity to develop expertise in external/vendor data processes
Flexible working arrangements and work-life balance
Structured onboarding and ongoing training

What you will do

Support review maintenance and management of external vendor data (central labs local labs and other third-party sources)
Develop and maintain Vendor Data Plans (VDP) including data quality review and reconciliation sections ensuring appropriate approvals and TMF filing
Collaborate with external vendors and sponsors to define study expectations milestones timelines and communication processes
Ensure external data transfers meet protocol requirements are in the correct format and map accurately to systems and subjects
Develop and validate external data edit checks and reports including approvals QC and UAT activities
Review discrepancies identified through edit checks and perform query management to resolve data issues
Maintain documentation of data issues ensuring proper tracking and resolution through study and vendor logs
Support protocol and eCRF design reviews from an external data perspective
Work with cross-functional study teams to identify and resolve issues impacting data quality and analysis
Support management of local laboratory data including QC of lab ranges and verification of subject-level data accuracy
Participate in study team and departmental meetings
Plan and support multiple external data management activities simultaneously providing updates to stakeholders as needed
Complete required company and sponsor training and ensure compliance with SOPs guidelines and regulatory standards
Contribute to additional tasks and activities as required

Your profile

University/college degree (Life Sciences Health Sciences IT or related field preferred) or equivalent experience
4 years of experience in clinical trials pharmaceutical biotechnology or related industries
Experience working with external/vendor data in clinical studies
Experience supporting multiple projects or workstreams simultaneously
Strong organisational planning and critical-thinking skills
Strong written and verbal communication skills with ability to engage stakeholders effectively
Ability to manage competing priorities and deliver under pressure
Proficiency in Microsoft Office tools and general technical aptitude
Ability to maintain confidentiality and handle sensitive data appropriately
Understanding of ICH-GCP principles

Nice to have

Project management experience
Experience working with central and local laboratory data
Familiarity with data reconciliation processes and data quality review practices
Basic understanding of medical terminology
Experience working in global or cross-functional environments

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