Senior Clinical Data Coordinator (Poland)

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Overview

The Senior Clinical Data Coordinator will participate in various clinical data management activities required to ensure that data captured in clinical trials undertaken, or managed by Indero, are collected, managed, and reported clearly, accurately and securely. This position conducts all activities in conformance with applicable regulatory requirements, industry guidelines, and Indero’s standard operating procedures (SOPs) while respecting sponsor’s requirements and timelines.

Responsibilities

• Adhere and promote company organizational values and related expected behaviors, follow company SOPs and processes for all deliverables, and ensure all trainings assigned to oneself are completed on time.
• Support Lead Data Manager in the areas of data review, including running SAS programs and using compare programs, reviewing manual listings, and adding/closing queries in EDC.
• Data reconciliation, including adding queries in EDC and reporting issues in the data clarification log.
• Discrepancy management (e.g., adding and closing queries).
• Reporting potential protocol deviations.
• Mark forms/subjects as DM reviewed or soft locked.
• Maintain study metrics; monitor study status (e.g., enrollment, CRFs monitored/approved, etc.) on an ongoing basis and provide data status reports to the project team as needed.
• Generate ad‑hoc study reports (e.g., central monitoring reports).
• Perform user acceptance testing.
• Enter dummy data in development environment.
• Ensure that data management documentation is complete and upload documents in the trial master file (TMF).
• Create data management plan (DMP), eCRF completion guidelines, and other clinical data management related documentation.
• Assist with reviewing statistical data issues reported by statistical programmers or Lead Biostatistician.
• Provide basic support to other Clinical Data Coordinators as needed.
• Contribute to the identification of future internal initiatives to increase efficiency/quality of data cleaning activities.
• Act as a back‑up for the Lead Data Manager during short periods.
• Assist in writing test cases.
• Help in allocating CDC resources for UAT testing or any other CDC activities.
• Mentor more junior Clinical Data Coordinators.
• Participate in internal initiatives to increase efficiency/quality of data cleaning activities.
• Assist Lead Data Managers in reviewing/validating initial manual listings.

Qualifications

• B.Sc. or related field.
• 1 to 3 years of clinical data management experience in the biotechnology, pharmaceutical or contractual research organization (CRO) industry.
• Skilled in use of computer technology and ability to learn new applications.
• Highly organized and detail‑oriented with effective project planning and time management skills.
• Strong verbal and written communication skills in English; French an asset.
• Ability to work in a fast‑paced environment with demonstrated agility to organize and prioritize multiple competing demands.
• Very good interpersonal, communication, problem solving and organizational skills with the ability to work both independently and in a team environment.
• General knowledge of CDISC standards (CDASH/SDTM) an asset.
• Understanding of the drug development process and of applicable regulations, including Good Clinical Practices, ICH Guidelines, GCP, applicable Health Canada and FDA regulations/guidelines an asset.

Benefits and Working Conditions

• Permanent full‑time position
• Flexible schedule
• Vacation
• Home‑based position
• Ongoing learning and development

Work Location

Remote work available anywhere in Poland.

Company

Indero (formerly Innovaderm) is a global clinical leader in dermatology. It is a dual‑focus CRO for dermatology and rheumatology, with 25+ years of experience in clinical research and trial delivery. Indero offers a worldwide footprint with capabilities in North America, Europe, Asia Pacific, and Latin America.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in Poland.

Job Details

• Seniority level: Entry level
• Employment type: Contract
• Job functions: Research, Analyst, and Information Technology
• Industries: Research Services