Tasks

  • Responsible for the strategic planning, setup, execution, and formal closeout of clinical projects (Phases I–III)
  • Accountable for leading trial operations to ensure high-quality delivery within established timelines and budget parameters
  • Develop and maintain trial-specific budgets, financial forecasts, project plans, and detailed timelines
  • Support the RFP (Request for Proposal) process and lead negotiations for vendor contracts and project-specific budgets
  • Ensure rigorous management and oversight of CROs and various third-party providers (e.g., central labs, IWRS, clinical supply distributors)
  • Provide operational expertise during the development and review of clinical protocols, Investigator’s Brochures (IBs), and Informed Consent Forms (ICFs)
  • Create and review study-related materials, including operational manuals, guidelines, visit reports, and newsletters
  • Oversee and perform User Acceptance Testing (UAT) for clinical systems implemented during the trial
  • Plan and lead project meetings, training workshops, and Investigator Meetings
  • Supervise the training of cross-functional team members to ensure consistent adherence to GCP and trial-specific monitoring standards
  • Prepare and present regular status updates, summary reports, and data analyses for assigned trials
  • Conduct co-monitoring visits and site oversight activities to verify trial quality at the source
  • Participate in internal and external audits and maintain a constant state of "inspection readiness"
  • Ensure the (e)TMF is correctly established, regularly reviewed for completeness, and kept up to date

Qualifications

  • Professional Experience: Minimum of 5 years in managing clinical trials (Phases I–III), ideally with a career progression from CRA to Global Clinical Trial Manager
  • Monitoring Background: At least one year of experience as a CRA is strongly preferred to ensure a deep understanding of site-level operations
  • Technical Proficiency: Solid command of clinical trial technologies, including EDC, IRT, eTMF, and CTMS
  • Regulatory Expertise: Robust understanding of ICH-GCP guidelines and clinical trial regulations across multiple geographies
  • Audit Experience: Prior involvement in regulatory inspections or internal audits is considered a significant asset
  • Competencies: Exceptional communication and organizational skills, a proactive approach to problem-solving, and efficient time management