Technical Data Manager (m/f/d)
- Zagreb
- Stalni radni odnos
- Puno radno vrijeme
- Working in a successful company that’s growing and developing every day
- Working with a highly experienced team of the clinical research professionals
- International projects and professional growth
- Performance bonus
- Employee engagement programs
- Well-being initiatives
- Training and development program
- Additional location specific benefits
- BS or higher degree in a bio-medical or technical discipline, such as Biology, Biochemistry, Medicine, Biostatistics, Mathematics, Bioinformatics or Enginery or relevant experience in the industry
- at least 2-3 years of experience in data management in Contract Research Organizations, pharmaceutical companies, biotech companies, or similar
- excellent technical knowledge and experience with R & Python
- good knowledge of GCP and ICH Guidelines
- good knowledge of the English language, spoken and written
- ability to communicate effectively with appropriate internal and external contacts
- ability to work on multiple projects and manage project timelines
- good organizational and time management skills and initiative
- good communication and presentation skills
- ability to define problems, collect data, establish facts, and draw valid conclusions
- working on ongoing clinical studies to assure results are consistent with expectations, and quality control procedures are followed
- participating in the creation and review of key data management documents including:
- CRF Specifications
- Case Report Forms
- Data Transfer Agreements/Specifications
- Data Management Plans
- Data Cleaning Plans
- eCRF Completion Guidelines
- preparing reports, listings, resource allocation forecasts and other
- writing specifications for the set-up and modification of electronic data capture systems and other clinical databases
- working with vendor System Administrators/Programmers to develop, test and validate all project specific programming (if required)
- performing verification and User Acceptance Testing of electronic data capture systems and other clinical databases
- defining, writing, and validating Manual and Automatic edit checks for clinical data cleaning
- supporting all data cleaning activities for assigned projects
- specifying and reviewing patient listings/tables for clinical data cleaning
- performing reconciliation of data from external sources
- coordinating database locks, performing data review meetings in collaboration required project team member, and Sponsor
- performing activities such as executing unblinded data exports from EDS and creating the IP inventory management setup with supervision
- performing medical coding using industry standard dictionaries
- applying company standards, and actively participating in improvements towards harmonization and standardization across projects
- participating in the creation and maintenance of the Data Management eCRF library
- initiating and/or participating in the improvement, development, and review of Company’s Controlled Documents
- participating as necessary in sponsor qualification, sponsor audits, regulatory authority inspections, and other third-party meetings. Ensure that any recommendations are discussed and that solutions are incorporated
- entering and updating data in relevant CTMS modules timely and accurately
- participating in Optimapharm resource planning activities, if requested