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- Tasks: Enter and resolve data queries for clinical trials, ensuring accuracy and timeliness.
- Company: Civia Health, a next-gen clinical trial delivery company.
- Benefits: Full-time role with opportunities for growth in a supportive environment.
- Other info: Work on-site in Sunderland with a focus on quality and collaboration.
- Why this job: Join a dynamic team making a real impact in clinical research.
- Qualifications: Clinical background or studies in a related field; EDC experience preferred.
The predicted salary is between 30000 - 40000 £ per year.
Location: Sunderland, UK (on-site at flagship research site)
Job Type: Full-Time
Reports To: Head of UK Delivery
Civia Health operates a next-generation SMO model designed for predictable, high-quality clinical trial delivery. 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, ensuring sponsor expectations are met.
Purpose of the Job
The DEQS supports the organization by offshoring data entry to a specialized team allowing site staff to focus on participants. The DEQS ensures that contractual timelines are met throughout the study, especially 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 proactively.
- Escalate clinical queries to site CRCs when judgement called above your grade.
- Spot trends and patterns across sites and studies.
- Work across multiple EDC platforms (Medidata Rave, Veeva, Oracle InForm) and adapt quickly to new systems as studies require.
- Site Support
- Share front-desk and reception duties ensuring welcoming, professional coverage for patients, sponsors, and visitors.
- Support 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 being chased.
- Suggest process improvements where you see inefficiency.
Performance Measures (KPIs)
- Timeliness of EDC Entry – % of visits entered within 48 hours; target ≥ 95% of visits entered within ≤ 2 business days.
- EDC Query Resolution Time – Query response time; target ≥ 95% of queries closed within ≤ 4 business days.
Ideal Phenotype
- Detail-obsessed: sees data entry as clinical work, every field matters. Naturally spots inconsistencies and flags them to reduce rework. Maintains clean, first-time-right data.
- Clinically Aware, Not Clinically Arrogant: Brings enough clinical common sense to know when something looks wrong. Escalates concerns to QC Lead or site CRCs rather than making judgement calls above their grade. Ideally comes from a clinical background such as nursing assistant, pharmacy tech, or CRC. Knows difference between an unusual value and a protocol deviation and communicates clearly.
- Disciplined and Self-Managing: Consistently meets 48-hour windows without being chased. Manages own workload across multiple sites and studies, spanning UK and US time zones. Works on-site at the flagship site; treats physical presence as part of the discipline. Follows SOPs to the letter while applying them with care. Tracks own throughput and quality; no dashboard needed.
- Adaptable Across Systems and Studies: Already familiar with multiple EDC platforms or can pick them up fast. Comfortable moving between studies with different protocols, therapeutic areas, and data structures. Focuses on metabolic and chronic ambulatory studies but not limited by variety.
- A Communicator, Not Just a Processor: Frames and articulates issues clearly when escalating. Notes trends across sites and studies. Welcomes process improvement suggestions. Establishes clear communication to reduce queries.
- Temperament and Character: Quiet, effective, heads-down. Quality-first mindset; speed balanced with accuracy. Collaborates when beneficial. Takes feedback constructively. Motivated for growth toward QC Lead or data management.
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 regulatory context.
- Comfortable working across UK and US sites and time zones.
- Early-career but serious, building toward a career in clinical data.
Role Differentiation
The Data Entry and Query Specialist differs from the Operational Compliance Specialist in that the core focus is on entry of data and resolution of queries, not on oversight and review of compliance. The DEQS operates without site boundaries and is based at a particular site.
Executive One-Liner
The DEQS is Civia Health's centralized data handler, ensuring every chart, source document, and data point is entered and answered in the EDC, even when clinical tasks take precedence 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.
Data Entry & Query Specialist in Sunderland employer: Civia Health
Contact Detail:
Civia Health Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Data Entry & Query Specialist in Sunderland
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend local meetups, or join online forums. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by practising common questions and scenarios related to data entry and query resolution. We recommend role-playing with a friend to get comfortable articulating your experience and skills.
✨Tip Number 3
Showcase your adaptability! Be ready to discuss how you've quickly learned new systems or processes in the past. Employers love candidates who can hit the ground running, especially in a fast-paced environment.
✨Tip Number 4
Don’t forget to follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Plus, it shows your enthusiasm for the role and the company.
We think you need these skills to ace Data Entry & Query Specialist in Sunderland
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Data Entry & Query Specialist role. Highlight your relevant experience, especially any clinical background or EDC platform familiarity, to show us you’re the right fit!
Show Off Your Attention to Detail: Since this role is all about accuracy, give us examples of how you've maintained high-quality work in the past. Whether it’s spotting inconsistencies or managing data entry, we want to see that detail-obsessed mindset!
Communicate Clearly: When writing your application, be clear and concise. We love candidates who can articulate their thoughts well, especially when it comes to explaining complex issues or suggesting process improvements.
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Civia Health
✨Know Your EDC Platforms
Familiarise yourself with the EDC platforms mentioned in the job description, like Medidata Rave and Veeva. Being able to discuss your experience or understanding of these systems will show that you're ready to hit the ground running.
✨Demonstrate Clinical Awareness
Prepare examples from your past experiences where you identified inconsistencies or escalated issues appropriately. This will highlight your clinical common sense and ability to communicate effectively, which are key for this role.
✨Showcase Your Attention to Detail
Be ready to discuss how you ensure accuracy in data entry and query resolution. Mention any specific methods or tools you use to track your work and maintain high-quality standards, as this aligns perfectly with the detail-obsessed nature they’re looking for.
✨Emphasise Adaptability
Think of instances where you've had to adapt quickly to new systems or processes. Share how you managed your workload across different projects, especially if you’ve worked across time zones, as this will demonstrate your ability to thrive in a dynamic environment.