Senior Clinical Data Coordinator (Poland)

The Senior Clinical Data Coordinator will participate in various clinical data management activities 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 standard operating procedures while respecting sponsor 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 but not limited to running SAS programs and using compare programs, reviewing manual listings, and adding/closing queries in EDC.
• Support Lead Data Manager in the areas of Data Reconciliation, including but not limited to adding queries in EDC and reporting issues in the data clarification log.
• Discrepancy Management (e.g. adding and closing queries).
• Reporting potential protocol deviation.
• Mark forms/subjects as DM reviewed or Soft Locked.
• Maintenance of Study Metrics; monitoring study status (e.g. enrollment, CRFs monitored/approved, etc.) on an ongoing basis and providing data status reports to the project team.
• Generation of 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 and quality of data cleaning activities.
• Act as a back‑up for the Lead Data Manager during short periods.
• Assist in writing test cases.
• Help allocate CDC resources for UAT testing or other CDC activities.
• Mentor more junior Clinical Data Coordinators.
• Assist Lead Data Managers in reviewing/validating initial manual listings.

Requirements

• 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 using 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; proficiency in French is 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; ability to work independently and in a team.
• General knowledge of CDISC standards (CDASH/SDTM) is an asset.
• Understanding of the drug development process and applicable regulations, including Good Clinical Practice, ICH Guidelines, GCP, Health Canada and FDA regulations/guidelines is an asset.

Benefits

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

Work environment and values: At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

Work location: The successful candidate will work remotely anywhere in Poland. Employees located outside North America are expected to have some flexibility to accommodate team or client meetings; all efforts will be made to accommodate various time zones.

About Indero: A global clinical leader in dermatology and rheumatology. Formerly known as Innovaderm, Indero is a world‑renowned clinical research leader with over two decades of experience and a global footprint.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. 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.