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Precision Medicine Group is seeking a Senior Clinical Data Manager to join their European team. This is a remote role based in Serbia.She will manage all aspects of the clinical trial data management process, from study start-up to post-database lock. She will be working in accordance with Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study-specific plans and guidelines. This position also involves overseeing and/or performing database development and testing.Responsibilities:
- Act as the primary Data Management (DM) contact for assigned clinical projects.
- Oversee the project data entry process, including the development of data entry guidelines, training, and quality control.
- Manage timelines and ensure clinical data management deadlines are met with quality.
- Develop CRF specifications from the clinical study protocol and coordinate feedback from stakeholders.
- Conduct database build UAT and maintain quality-controlled database build documentation.
- Oversee the development of edit check specifications and manual data review specifications.
- Train clinical research personnel on study-specific CRF, EDC, and other project-related items.
- Review and query clinical trial data according to the Data Management Plan.
- Perform medical coding of medical terms.
- Liaise with third-party vendors in a project manager capacity.
- Bachelor's degree and/or a combination of related experience.
- 8+ years of experience with strong Oncology and/or Orphan Drug therapeutic experience.
- Experience in a clinical, scientific or healthcare discipline.
- Dictionary medical coding (MedDRA and WHODrug).
- Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…).
- Experience in utilizing various clinical database management systems.
- Proficiency in Microsoft Office.
- Ability to travel occasionally.
- Remote work opportunity.
Precision Medicine Group
Precision Medicine Group is a specialized company operating in the financial and operational aspects of project management, particularly within the Clinical Research Organization (CRO) industry. They excel in managing and coordinating change orders, working closely with project management, financial analysts, and functional leads. Their expertise lies in providing detailed variance analysis, budgeting, financial forecasting, and maintaining meticulous financial records. They ensure regulatory compliance and adapt to evolving project requirements. The company emphasizes accuracy, strategic communication, and collaboration with both internal teams and external stakeholders.