Location: Sunderland, UK (on-site at flagship research site)
Job Type: Full-Time
Reports To: Head of UK Delivery

Join Us at Civia HealthCivia Health operates a next-generation SMO model designed for predictable, high-quality clinical trial delivery. Our approach depends on seamless alignment across specialized functions, supported by disciplined governance, transparency, and performance accountability.
Within this model, the Data Entry and Query Specialist serves as the data entry and query support, centrally supporting the organization.
The DEQS ensures that source data is entered into the EDC and queries are resolved within internally agreed timelines (as per the data compliance plan), ensuring sponsor expectations are met. Purpose of the JobThe DEQS supports the organization by offshoring data entry to a specialized team allowing the site staff to focus their time on seeing participants. The DEQS ensures that contractual timelines are met throughout the study, but critically at key milestones such as data cuts or database lock. Key Responsibilities

• Data Entry & Query Resolution
  • Perform centralized EDC data entry for assigned US and UK sites, consistently within 48 hours of patient visit.
  • Resolve data queries within 48 hours, applying clinical common sense to identify root causes before responding.
  • Flag clinical inconsistencies to the QC Lead as they arise — proactively, not reactively.
  • Escalate clinical queries to site CRCs where judgement calls sit above your grade.
  • Spot trends and patterns across sites and studies, not just individual data points.
  • Work across multiple EDC platforms (e.g. Medidata Rave, Veeva, Oracle InForm) and adapt quickly to new systems as studies require.
• Site Support
  • Share front desk and reception duties with your fellow specialist, ensuring welcoming, professional coverage for patients, sponsors, and visitors.
  • Support the smooth day-to-day running of the Sunderland research site.
• Quality & Process
  • Follow SOPs meticulously while understanding why the process exists.
  • Track your own throughput and quality without needing to be chased.
  • Suggest process improvements where you see inefficiency — your input is welcomed.

Performance Measures (KPIs)

KPI / Metric	What’s Reviewed	Target
Timeliness of EDC Entry	% of visits entered within 48 hours	≥ 95% of visits entered ≤ 2 business days
EDC Query Resolution Time	Query response time	≥ 95% of queries closed ≤ 4 business days

Ideal PhenotypeDetail-Obsessed by Nature

• Sees data entry as clinical work, not admin — every field matters because a patient sits behind it.
• Naturally spots inconsistencies: a lab value that doesn’t match a visit date, a dose that contradicts the protocol.
• Doesn’t wait for QC to catch errors — flags as they go, reducing rework downstream.
• Takes pride in clean, first-time-right data; treats avoidable queries as a personal failure, not someone else’s problem.

Clinically Aware, Not Clinically Arrogant

• Brings enough clinical common sense to know when something looks wrong — a vitals reading that doesn’t make sense, a medication conflict, a timeline gap.
• Doesn’t play doctor: flags concerns to the QC Lead or escalates clinical queries to site CRCs rather than making judgement calls above their grade.
• Ideally comes from a clinical background — nursing assistant, pharmacy tech, CRC — where they’ve been close enough to patient data to understand its weight.
• Knows the difference between “that’s unusual” and “that’s a protocol deviation” — and communicates the distinction clearly.

Disciplined and Self-Managing

• Consistently meets 48-hour data entry and query resolution windows without being chased.
• Manages their own workload across multiple sites and studies, potentially spanning UK and US time zones.
• Works primarily on-site at the flagship site; treats physical presence as part of the discipline, not a burden.
• Follows SOPs to the letter but isn’t robotic — understands why the process exists and applies it with care.
• Tracks their own throughput and quality; doesn’t need a dashboard to know where they stand.

Adaptable Across Systems and Studies

• Either already familiar with multiple EDC platforms (Medidata Rave, Veeva, Oracle InForm) or picks them up fast without complaint.
• Comfortable moving between studies with different protocols, therapeutic areas, and data structures.
• Doesn’t need handholding on new systems — finds the logic in each platform and adapts.
• Focused primarily on metabolic and chronic ambulatory studies but not thrown by variety.

A Communicator, Not Just a Processor

• Can frame and articulate issues clearly when escalating to the QC Lead or site CRCs — not just “this looks wrong” but “here’s what I’m seeing, here’s why it matters, and here’s what I’d suggest.”
• Notes trends and patterns across sites and studies, not just individual data points.
• Welcomes the chance to suggest process improvements rather than silently enduring inefficiency.
• Understands that poor communication downstream creates more queries, not fewer.

Temperament and Character

• Quiet, effective, heads-down — gets energy from doing the work well, not from being seen.
• Quality-first mindset: speed matters, but not at the expense of accuracy. Trusts that pace comes with familiarity.
• Individual output is their primary currency at this level, but they’re not a loner — they collaborate when it serves the data.
• Takes feedback constructively; sees corrections as learning, not criticism.
• Motivated by growth — sees this role as a stepping stone toward QC Lead or data management, not a dead end.

Qualifications and Experience

• Clinical foundation: medical assistant, pharmacy tech, clinical research coordinator, or currently studying in a clinical field.
• EDC experience across one or more platforms; query resolution experience strongly preferred.
• Familiarity with Phase 2/3 trial data flows and the regulatory context behind clean data.
• Comfortable working across UK and US sites and time zones.
• Early-career but serious — someone building toward a career in clinical data, not filling a gap.

Role DifferentiationThe Data Entry and Query Specialist (DEQS) is distinctly different from the Operational compliance specialist (OCS) as the core focus is on the entry of data and resolution of queries, versus the direct oversight and review of how the data/queries collected are in compliance to our processes and approved documents. The DEQS will operate without site boundaries regardless of being based at a particular site.
Executive One-LinerThe DEQS is Civia Health's centralized data handler, ensuring every chart, every source document, and every data point is entered and answered in the EDC, even when clinical tasks take precedent at site.CIVIA HEALTH VALUES IN ACTION

• Empathy: Approach site staff with understanding, meeting them where they are to elevate quality together.
• Integrity: Hold the line on compliance, even when it means flagging uncomfortable findings.
• Trust: Build confidence through thoroughness, consistency, and follow-through on every query.
• Community: Collaborate across QA, data, and site ops to strengthen the collective standard.
• Relentless Self-Improvement: Stay current on EDC guidelines and continuously strive to improve quality at grass roots.

WHY CIVIA HEALTH

Join a purpose-driven organization redefining clinical research by connecting science with humanity. As part of our quality and operations team, you will play a direct role in ensuring the integrity of clinical trial data, protecting patient safety, and maintaining the standards that earn and sustain sponsor confidence.