Clinical Data Coordinator II

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 end-to-end Clinical Data Management activities across multiple studies
• Assist with database testing and validation prior to study activation
• Prepare and maintain study-specific Data Management documentation
• Review CRFs critically, identifying data inconsistencies, errors, or missing information
• Raise, track, and resolve data queries and Data Clarification Forms (DCFs)
• Manage self-evident queries and allowable data changes within the database
• Perform quality control checks on data entry and database outputs
• Support study close-out activities, including preparation of archival documentation
• Ensure compliance with SOPs, ICH-GCP, regulatory requirements, and client standards
• Contribute to process improvement initiatives and data management best practices
• Perform medical coding activities when assigned
• Collaborate with offshore data processing and programming teams
• Provide project updates and support progress tracking using reports and metrics
• Take on ad-hoc tasks as required to support project and team objectives
  
  

What You’ll Gain

• Exposure to full lifecycle Clinical Data Management across diverse studies
• Hands-on experience working with industry-leading CDM systems
• Opportunity to collaborate with cross-functional and global teams
• Development of leadership, coordination, and project oversight skills
• A supportive environment that values quality, compliance, and continuous improvement
• Career growth within a regulated and evolving clinical research setting
  
  

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)

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