Clinical Data Coordinator (remote/hybrid, full-time)

Permanent employee, Full-time · SA

Job purpose

The Clinical Data Coordinator is responsible for supporting the day‑to‑day operational activities required to ensure high‑quality, accurate, and timely clinical trial data. Working under the guidance of Clinical Data Managers, the CDC performs routine data cleaning, query management, documentation, and system‑related tasks essential to the success of global clinical studies. This role contributes to database maintenance, supports cross‑functional collaboration, and ensures adherence to established processes, timelines, and quality standards. The CDC plays a key role in maintaining audit‑ready data and enabling smooth study execution throughout the clinical data lifecycle.

Responsibilities

The responsibilities for the Clinical Data Coordinator include, but are not limited to, the following:

Perform routine data cleaning activities, including query generation, review, and resolution tracking, in accordance with study timelines and data management plans.
Review data for completeness, accuracy, and consistency, escalating issues to the Clinical Data Manager (CDM) as appropriate.
Support ongoing data review cycles and contribute to maintaining audit‑ready, high‑quality datasets throughout the study.
Assist in managing data listings, validation outputs, and data reconciliation activities (e.g., SAEs, vendor data, coding).
Assist in the review and testing of database builds, updates, and system enhancements under the supervision of the CDM.
Perform User Acceptance Testing (UAT) tasks by executing test scripts and documenting outcomes accurately.
Monitor system performance and report issues or discrepancies to the study’s CDM or technical teams.
Maintain accurate and complete project documentation, including trackers, logs, meeting notes, and study‑specific forms.
Ensure all tasks are completed in compliance with SOPs, work instructions, study protocols, and GCP requirements.
Support preparation activities for internal and external audits or inspections.
Collaborate with Clinical Data Managers, Data Associates, programmers, and other study stakeholders to support efficient study execution.
Communicate clearly and proactively to ensure timely resolution of data‑related queries and tasks.
Provide regular updates on assigned activities, challenges, and progress.
Assist in developing and maintaining study‑specific trackers, metrics, and project status reports.
Contribute to the review and improvement of internal processes, tools, and templates.
Support training activities for new team members when appropriate, offering guidance on routine tasks.
Perform other data‑related tasks as assigned by the Clinical Data Manager or Line Manager to support successful study outcomes.

Experience - the ideal candidate will have

A minimum of 4 years of experience in Clinical Data Management, preferably supporting global Phase I–III trials.
Hands‑on experience with routine data cleaning activities, including query management, data review, and issue escalation.
Familiarity with EDC systems (e.g., Medidata Rave, Inform, Veeva EDC, or equivalent) and willingness to gain deeper system expertise.
Understanding of GCP, ICH guidelines, and relevant regulatory expectations related to data integrity and documentation.
Experience supporting database testing activities, such as UAT execution and documenting test results.
Strong attention to detail with a consistent track record of accuracy in data review tasks.
Ability to follow established processes and instructions, while proactively identifying potential data issues and bringing them to the CDM’s attention.
Comfortable working with spreadsheets, study trackers, and data review tools, with solid proficiency in Microsoft Excel.
Experience working in cross‑functional, global teams and collaborating effectively with colleagues across multiple time zones.
Adaptability in fast‑paced environments, with the ability to manage routine tasks while supporting shifting study needs.

Experience - you must also have these skills

Strong written and verbal communication skills, with the ability to clearly document findings and collaborate effectively with team members.
Ability to work independently on assigned tasks, including in remote settings, while maintaining strong teamwork and responsiveness.
Flexible and adaptable mindset, able to adjust to shifting priorities, timelines, and study requirements.
Excellent organizational skills and attention to detail, ensuring accuracy and consistency in all data‑related deliverables.
A proactive, hands‑on approach, demonstrating initiative and a commitment to completing tasks on time and to a high standard.
Proficiency in Microsoft Office, particularly Excel, and a willingness to learn new systems, tools, and processes (e.g., EDC platforms, trackers, validation tools).
Strong interpersonal skills and cultural awareness, enabling effective collaboration with colleagues across diverse, global teams.
Comfortable working in fast‑paced environments, managing routine tasks while supporting evolving study needs.

Why us?

You will join a young, very dynamic, and fast‑growing private research organization. Our passionate, truly multicultural, and diverse team of nearly 500 colleagues and nearly 40 nationalities include epidemiologists, clinical operations, CRAs, CTAs, data scientists, statisticians, data analysts, medical writers, safety and pharmacovigilance specialists, project managers and business support professionals spreading over 20 countries.

We all work remotely, setting our own time schedule, based on a “getting the job done” mentality. This has a positive impact in our work‑life balance. Our headquarters are in Leuven (Belgium), but we also have local and regional offices located in Rotterdam and Zeist (the Netherlands), Bogota (Colombia), Johannesburg (South Africa), Bangkok (Thailand), Paris (France), Casablanca (Morocco) as well as Marietta and Durham (United States). You may need to travel occasionally.

At P95, we are a collaborative and international team that works on diverse projects, topics, and clients and faces interesting challenges. There is a high level of empowerment, flexibility, autonomy as well as opportunities for research and development, to make things happen. We have an open culture of respect and inclusion. Consequently, we value self‑reliance, initiative, and responsibility of everyone in our team to meet our internal and external customers’ expectations. Finally, our colleagues experience a strong sense of meaning and purpose driven by the scientific nature and impact of our work.

P95 and Julius Clinical have recently joined forces, bringing together two highly complementary organizations with a shared mission: advancing global health through high‑quality epidemiological research and clinical trials.

P95, founded in 2011 and headquartered in Belgium, is a global leader in epidemiology, vaccines, and infectious disease research. With offices across Europe, North America, South America, Africa, and Southeast Asia, P95 supports public health agencies, pharmaceutical companies, academic institutions, and global organizations such as WHO and the European Commission. Our work focuses on generating timely, pragmatic, and actionable insights to improve access to safe and effective vaccines.

Julius Clinical, founded in 2008 and based in Zeist, The Netherlands, is a leading clinical CRO known for its strong scientific leadership and operational excellence. With more than 400 clinical trials conducted and over 300,000 participants enrolled worldwide, Julius Clinical specializes in central nervous system, cardio‑metabolic, renal, and rare diseases, working closely with biotech and mid‑sized pharma partners.

Together, we form a global, science‑driven organization offering an integrated portfolio of epidemiological and clinical research services. Our teams combine deep scientific expertise, operational excellence, and a shared passion for improving healthcare outcomes.

P95 and Julius Clinical are part of the Ampersand Capital Partners portfolio, a healthcare‑focused private equity firm.

We are united by a commitment to scientific rigor, innovation, and meaningful impact and we are excited to welcome new colleagues who share our ambition to improve global health.

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