Clinical Data Coordinator I

Description

At Quanticate, we're pioneers in providing top-tier statistical and data management support to our clients.

Are you passionate about clinical research and data excellence? Do you thrive in fast-paced, dynamic environments where your attention to detail can make a real impact on patient outcomes? We’re looking for a Clinical Data Coordinator II to be at the heart of our studies, ensuring top-quality data from start to finish.

What You’ll Do

• Support database testing: Help validate study databases before activation.
• Prepare documentation: Assist in creating study-specific materials.
• Process clinical data: Ensure accuracy and completeness of project data.
• Review CRFs: Critically check Case Report Forms against the Data Management Plan and raise queries when needed.
• Resolve queries: Track and resolve Data Clarification Forms, self-evident queries, and allowable changes.
• Perform quality control: Conduct QC checks on data entry and CRFs/databases.
• Manage archiving: Prepare documentation for client return or internal archiving at study completion.
• Contribute to improvements: Suggest enhancements to processes and standards.
• Medical coding: Perform coding activities when assigned.
• Collaborate with teams: Work with project managers, sponsors, investigators, and offshore teams to ensure smooth delivery.
  
  

What You’ll Gain

• Hands-on experience: Exposure to end-to-end clinical data management across multiple studies.
• Skill development: Strengthen expertise in database testing, CRF review, query resolution, and medical coding.
• Quality mindset: Learn to work to industry standards, SOPs, and regulatory guidelines.
• Career growth: Build a foundation for advancement in clinical data management and project leadership.
• Collaboration opportunities: Gain experience working with global teams and diverse stakeholders.
• Contribution to healthcare: Play a vital role in ensuring reliable data that supports medical research and patient outcomes.
  
  

Quanticate is the world leading data-focused CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical programming, statistics and data management input. We need talented individuals to help us fulfil our customers’ needs.

Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical program, to small biotechs that are taking their first steps in clinical development

We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.

Requirements

Knowledge:

• Strong understanding of Clinical Data Management processes
• Solid knowledge of ICH-GCP guidelines and regulatory requirements related to data handling
• Familiarity with CRO and sponsor-driven study standards
  
  

Work Experience

• Prior experience in Clinical Data Management or a similar role
• Hands-on experience with at least one CDM system (e.g., Oracle Clinical, Medidata Rave, Inform)
• Experience supporting multiple studies or managing competing priorities is preferred
  
  

Skills

• Excellent attention to detail and strong analytical thinking
• Good written and verbal communication skills
• Strong organizational and time-management abilities
• Ability to work effectively in a fast-changing, deadline-driven environment
• Comfortable working with offshore or remote teams
• Proficient in Microsoft Word and Excel
• Team-oriented mindset with the ability to motivate and collaborate effectively
  
  

Quanticate will never ask for payments as part of the recruitment or hiring process, and all legitimate correspondence from Quanticate will come exclusively from our @quanticate.com domain name. Hiring at Quanticate is based purely on merit and we do not ask or require candidates to deposit any money or complete any paid for courses as part of the process. Further guidance on our recruitment process and tips on how to stay safe during your job search can be found on our website at https://www.quanticate.com/careers-guidance.

Benefits

• Competitive salary
• Flexible working hours
• Holidays (Annual Leave, Sick Leave, Casual Leave and Bank holidays)
• Medical Insurance for self and immediate family
• Gratuity
• Accidental Coverage
• Quanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e- learning, job shadowing)