Clinical Data Coordinator II

Kapadi Pty; Polska; On-site; PLN 60,000 - 100,000; Full time

Benefits offered by this job

Work in a growing CRO in Poland

Opportunities to influence process in/

Job summary

Kapadi Pty is seeking a data management support specialist to assist the Clinical Data Manager in daily tasks for clinical trials. You will perform data management activities in line with study plans, SOPs and regulatory requirements, and help review data in the EDC system to ensure completeness and accuracy.

You will contribute to maintaining study documentation, developing CRFs, and generating study metrics.

Qualifications

• Degree or equivalent qualification in Life Sciences, Health Sciences, Pharmacy, Biotechnology, Data Management or related discipline.
• Experience in clinical research or data management is preferred.
• Knowledge of GCP and clinical trial processes is desirable.
• Familiarity with EDC systems and data management processes.
• Strong Excel skills and ability to work with large data volumes.

Responsibilities

• Support the Clinical Data Manager in day-to-day management of clinical trial data.
• Perform data management activities per study plans, SOPs and regulatory requirements.
• Assist in review and cleaning of data in the EDC system according to timelines.
• Review data for completeness and accuracy, identify discrepancies.
• Assist in maintaining study documentation (DMPs, data review guidelines).
• Support development, testing and maintenance of CRFs and EDC systems.
• Prepare study metrics, data listings, and status reports.
• Ensure data management activities comply with regulations and ICH-GCP.
• Support data transfer and reconciliation with internal departments and vendors.
• Participate in study meetings and provide task updates.

Skills

Life Sciences degree

Clinical data management

GCP knowledge

EDC systems

Excel proficiency

Attention to detail

Time management

Independent worker

Analytical skills

R/SAS programming

Education

Life Sciences or related degree

Tools

EDC systems

Microsoft Excel

Job description

• support the Clinical Data Manager in the day-to-day management of clinical trial data,
• perform assigned data management activities in accordance with study-specific plans, procedures, SOPs, working instructions and applicable regulatory requirements,
• support the review and cleaning of clinical trial data entered in the EDC system in accordance with the study-specific requirements and agreed timelines,
• review data for completeness, consistency and accuracy and identify potential discrepancies requiring follow-up,
• assist in maintaining study documentation, including Data Management Plans (DMPs), data review guidelines, and other study-related documents,
• support the development, testing, and maintenance of Case Report Forms (CRFs) and electronic data capture (EDC) systems,
• contribute to the preparation of study metrics, data listings, and status reports,
• ensure data management activities are performed in compliance with applicable regulations, ICH-GCP guidelines, and company standards,
• support data transfer and reconciliation activities with internal departments and external vendors,
• participate in study meetings and provide updates on assigned data management tasks.

Our requirements

• degree or equivalent qualification in Life Sciences, Health Sciences, Pharmacy, Biotechnology, Data Management or a related discipline,
• previous experience in clinical research, clinical data management or a related field,
• knowledge of clinical trial processes and Good Clinical Practice (GCP),
• familiarity with Electronic Data Capture (EDC) systems and clinical data management processes,
• good working knowledge of Microsoft Office, particularly Excel,
• strong attention to detail and ability to work accurately with large volumes of data,
• good organizational and time-management skills,
• ability to work independently on assigned activities while operating effectively within a team,
• Good analytical and problem-solving skills,
• some programming skills (R, SAS) - nice to have.

What we offer

• work in a developing CRO in Poland with foreign branches,
• recommending appropriate solutions in projects,
• impact on changes in processes in the Data Management area,
• stable employment in the company awarded Top Employer 2026,