O pozici
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.
Co budeš dělat
- 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
Koho hledáme
- 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
Benefity
- 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
