Senior Clinical Data Manager

This is a fully remote position, open to applicants in Poland, +1 more country.

📋 Description

• Ensure that data collected from various clinical trials is managed, reported, and captured in a clear, accurate, and secure manner.

• Lead data management operations throughout studies, from protocol review to database lock.

• Monitor the status of studies, including enrollment and the approval/monitoring of CRFs.

• Present project deliverables to clients, solicit feedback, and propose effective solutions.

• Provide the project team with regular updates on data status.

• Supervise the work of Clinical Data Coordinators to ensure quality and timeliness.

• Manage vendors to guarantee that timelines and deliverables align with sponsor and protocol requirements.

• Maintain the clinical database, conducting data reviews and cleaning during the study and in preparation for database lock.

• Reconcile external data with EDC data, including sponsor safety databases pertaining to adverse and serious adverse events.

• Formulate data management plans.

• Design electronic case report forms (eCRFs) and establish clinical databases within the chosen EDC.

• Coordinate validation of clinical databases and user acceptance testing.

• Assist in the development of external clinical data systems, such as ePRO or IWRS, and document/test data transfers.

• Create eCRF completion guidelines and training materials.

• Train site users and monitors on the clinical database.

• Activate or deactivate database users while maintaining records of requests.

• Address user inquiries regarding EDC assistance.

• Generate data listings and reports for review prior to database closure/lock.

• Ensure that data management documentation is thorough and up-to-date in the TMF.

• Archive the clinical database along with associated documents.

⛳️ Requirements

• Bachelor’s or Master’s degree in a relevant field.

• Seven years of clinical data management experience within the pharmaceutical industry or in a CRO setting.

• At least three years of experience as a lead data manager.

• Extensive experience with EDC systems.

• Preference for experience with Medrio and Medidata Rave.

• Highly organized with a keen attention to detail.

• Skills in project planning and time management.

• Strong verbal and written communication proficiency in English.

• Understanding of the drug development process and the applicable regulations, including Good Clinical Practices (GCP) and ICH Guidelines.

• Good knowledge of CDISC SDTM/CDASH standards.

• Familiarity with MedDRA and WHODrug dictionaries is advantageous.

• Must possess legal eligibility to work in Poland.

🏝️ Benefits

• Flexible working hours.

• Permanent full-time employment.

• Continuous learning and professional development opportunities.

• Attractive prospects for career advancement.

• Commitment to equitable treatment and equal opportunities.

• Accommodations for recruitment and selection processes for applicants with disabilities upon request.