Clinical Data Manager – FSP

This is a fully remote position, open to applicants in Poland.

📋 Description

• Take the lead on a small clinical study or co-lead larger studies with moderate supervision.

• Provide support for multiple clinical studies with minimal oversight.

• Oversee and track the progress of data management tasks alongside CROs or other vendors for assigned studies.

• Evaluate protocols to ensure proper data capture, including the design of electronic Case Report Forms (eCRF).

• Conduct comprehensive reviews of eCRF data requirements.

• Collaborate with CRAs, programmers, study managers, and statisticians in the design of eCRFs and the creation of annotated eCRFs and CRF completion guidelines.

• Create specifications for data edit checks and generate data listings as necessary.

• Coordinate the development and testing of Electronic Data Capture (EDC) systems in compliance with company standards.

• Resolve EDC system issues in collaboration with team members.

• Formulate the Data Management Plan for a clinical study.

• Review and provide feedback on other study documents, such as Clinical Monitoring Plans, Statistical Analysis Plans, and vendor specifications.

• Input data queries into the EDC system for resolution at investigational sites and manage query resolutions.

• Reconcile header data from external sources with the clinical database.

• Carry out Serious Adverse Event reconciliation activities according to SOPs and guidelines.

• Assist in database upgrades and migrations, including conducting User Acceptance Testing.

• Maintain study workbooks and data management files effectively.

• Execute database lock and freeze activities in accordance with company SOPs.

• Engage in regular team meetings and contribute when necessary.

• Provide input for the development of data management SOPs, Work Instructions, and process documentation.

• Aid in training new employees and/or contractors.

• Collaborate with cross-functional teams to design and execute effective data collection strategies, ensuring high-quality data capture and timely resolution of data queries throughout the clinical trial lifecycle.

⛳️ Requirements

• Bachelor’s Degree required (master’s preferred), ideally in a scientific or healthcare-related field.

• Minimum of five years’ experience in Data Management within the pharmaceutical or biotechnology sector.

• Familiarity with the scope and focus of Phase I – IV clinical studies, along with a demonstrated ability to perform core Data Management tasks and engage with vendors.

• Knowledge of regulatory guidelines and industry standards (such as ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application in Data Management practices.

• Strong attention to detail and the capacity to work independently, within a multidisciplinary team, and with external partners and vendors.

• Detail-oriented with a proven capacity to multitask and operate autonomously.

• Excellent time management and organizational skills, complemented by advanced problem-solving and analytical capabilities.

• Proficient in English, with strong written and verbal communication skills.

• Willingness to travel occasionally for meetings or training seminars.

🏝️ Benefits

• Annual performance-based bonus plan

• Annual salary review

• Total rewards incentives