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Precision Medicine Group is seeking a Senior Clinical Data Manager to join their European team. This role involves managing all aspects of the clinical trial data management process from study start-up to post-database lock.Responsibilities include:
- Serving as the primary Data Management contact for assigned clinical projects.
- Overseeing project data entry processes.
- Managing timelines and ensuring deadlines are met with quality.
- Developing CRF specifications and coordinating stakeholder feedback.
- Conducting database build UAT and maintaining quality-controlled documentation.
- Specifying requirements for all edit check types.
- Overseeing the completeness of data management documentation for the Trial Master File.
- Training clinical research personnel.
- Reviewing and querying clinical trial data.
- Performing medical coding.
- Liaising with third-party vendors.
- Identifying and troubleshooting operational problems.
- Participating in the development and maintenance of SOPs.
- Communicating with study sponsors, vendors, and project teams.
- Bachelor's degree and/or related experience.
- 8+ years’ experience with strong Oncology and/or Orphan Drug therapeutic experience.
- Dictionary medical coding (MedDRA and WHODrug).
- Understanding of CDISC standards.
- Experience in utilizing various clinical database management systems.
- Proficiency in Microsoft Office.
- Broad knowledge of drug, device and/or biologic development.
- Excellent organizational, communication, and representational skills.
- Professional use of the English language.
- Strong leadership and interpersonal skills.
- Ability to undertake occasional travel.
- A fully remote position within Europe.
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.