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Precision Medicine Group is seeking a Senior Clinical Data Manager to join their European team. This role is crucial for managing all aspects of the clinical trial data management process, from study start-up to post-database lock.She will be the primary Data Management contact for assigned clinical projects, ensuring responsiveness and timely task completion. They might oversee project data entry, provide input on timelines, and ensure data management deadlines are met with high quality. She may also assist in SAS programming and quality control of SAS programs.Role Involves:
- Overseeing project data entry and quality control.
- Developing CRF specifications and coordinating feedback.
- Conducting database build UAT and maintaining documentation.
- Reviewing and querying clinical trial data.
- Performing medical coding.
- Liaising with third-party vendors.
- Identify and troubleshoot operational problems.
- Reviewing protocols, SAPs, and CSRs.
- Participating in SOP development.
- Training clinical research personnel.
- Bachelor's degree and/or related experience.
- 8+ years of experience with Oncology and/or Orphan Drug therapeutic experience.
- Experience in clinical database management systems.
- Dictionary medical coding (MedDRA and WHODrug) knowledge.
- Understanding of CDISC standards.
- Proficiency in Microsoft Office.
- Knowledge of drug, device, and/or biologic development.
- Excellent communication and organizational skills.
- Professional use of English.
- Strong leadership and interpersonal skills.
- 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.