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
Learn more about our EEO & Accommodations request here.
Skills Required
- University/college degree in Life Sciences, Health Sciences, IT, or related field 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
- 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
- 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
What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
