Senior Clinical Data Manager/Principal Clinical Data Manager

hace 4 semanas

Alcobendas, Madrid, España Precision Medicine Group A tiempo completo

Job Summary:

The Senior Clinical Data Manager/Principal Clinical Data Manager is a key member of our team at Precision Medicine Group, responsible for managing all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects. This role requires a strong understanding of clinical research and data management principles, as well as excellent organizational and communication skills.

Key Responsibilities:

  • Primary Data Management contact for assigned clinical projects/programs, ensuring timely completion of tasks and effective communication with stakeholders.
  • Oversee project data entry process, including development of data entry guidelines, training, and quality control.
  • Provide input on project timelines and ensure that clinical data management deadlines are met with quality.
  • Develop CRF specifications from the clinical study protocol and coordinate review/feedback from stakeholders.
  • Conduct database build UAT and maintain quality-controlled database build documentation.
  • Specify requirements for edit checks and oversee development of edit check specifications.
  • Responsible for creating, revising, and maintaining data management documentation.
  • 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 line listing data review and run patient and study level status and metric reporting.
  • Perform medical coding and coordinate SAE/AE reconciliation.
  • Liaise with third-party vendors in a project-manager capacity to support timelines and data-related deliverables.
  • May assist with SAS programming and quality control of SAS programs.
  • Identify and troubleshoot operational problems and issues for studies based on metrics data and audit reports.
  • May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP), and Clinical Study Reports (CSRs).
  • Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation.
  • May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, and potential client engagement meetings.
  • May review Request for Proposals (RFP) and provide project estimates.
  • Provide leadership for cross-functional and organization-wide initiatives.
  • Train and ensure that all data management project team members have been sufficiently trained.
  • Communicate with study sponsors, vendors, and project teams as needed regarding data, database, or other relevant project issues.
  • May present software demonstrations/trainings, department/company training sessions, and present at project meetings.
  • May require some travel.

Qualifications:

  • Bachelor's degree and/or a combination of related experience.
  • Must have worked as a Lead Data Manager for a Clinical Research Organisation.
  • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
  • Able to handle a variety of clinical research tasks.
  • Excellent organizational and communication skills.
  • Professional use of the English language; both written and oral.
  • Experience in utilizing various clinical database management systems.
  • Broad knowledge of drug, device, and/or biologic development and effective data management practices.
  • Strong representational skills, ability to communicate effectively orally and in writing.
  • Strong leadership and interpersonal skills.
  • Ability to undertake occasional travel.

Preferred Qualifications:

  • Experience in a clinical, scientific, or healthcare discipline.
  • Dictionary medical coding (MedDRA and WHODrug).
  • Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.).
  • Oncology and/or Orphan Drug therapeutic experience.

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