Browse All Jobs

Senior Clinical Data Manager at Precision Medicine Group

Senior Clinical Data Manager managing clinical trial data.
Remote
Romania
Undisclosed salary
Precision Medicine Group is seeking a Senior Clinical Data Manager to join their European team. This role is fully remote and can be based in the UK, Spain, Poland, Slovakia, Romania, Hungary, or Serbia. The Senior Clinical Data Manager manages all aspects of the clinical trial data management process from study start-up to post-database lock. They will also oversee and/or perform database development and testing. Role involves:
  • Acting as the Primary Data Management contact.
  • Overseeing project data entry process, including development of data entry guidelines, training, and quality control.
  • Developing CRF specifications and coordinating review/feedback from stakeholders.
  • Conducting database build User Acceptance Testing (UAT) and maintaining quality-controlled documentation.
  • Overseeing development of edit check specifications and manual data review specifications.
  • Training clinical research personnel.
  • Reviewing and querying clinical trial data.
  • Performing medical coding.
  • Liaising with third-party vendors.
Requirements:
  • Bachelor's degree or equivalent experience.
  • 8+ years of experience with Oncology or Orphan Drug therapeutic experience.
  • Experience in dictionary medical coding (MedDRA and WHODrug).
  • Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.).
  • Experience with clinical database management systems.
  • Proficiency in Microsoft Office.
  • Knowledge of drug, device, and/or biologic development.
  • Excellent organizational, communication, and leadership skills.
  • Professional use of the English language.
Role offers:
  • Remote work opportunity.
  • Opportunity to work with a growing Data Management team.
Apply

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.