JOB INFORMATION

  • Job Title:
    CRM (Clinical Research Manager)
  • Job type:
    Full time
  • Workplace type:
    On site
  • Job Reference:
  • Location:
    Lebanon
  • Reports To:
    Vice President Operations
  • Job Description:

     

    1. Manage Site Selection and Monitoring:
      • Oversee the selection, qualification, initiation, monitoring, and close-out of clinical trial sites.
      • Lead a team of CRAs in conducting site visits and ensuring adherence to protocols and regulations.
    2. Ensure Regulatory Compliance:
      • Develop and implement strategies to guarantee all regulatory documents meet quality standards and adhere to GCP and ICH guidelines.
      • Supervise the CRA team in managing regulatory submissions and addressing queries from regulatory bodies.
    3. Manage Informed Consent and Contracts:
      • Lead the review and approval process for Informed Consent Forms (ICFs) and other essential documents.
      • Oversee contract negotiation and ensure timely signatures from investigators and hospitals.
    4. Manage Study Conduct and Data Quality:
      • Lead the development and delivery of protocol training for assigned sites.
      • Manage and monitor data quality through source data verification, risk-based monitoring, and data query resolution.
    5. Oversee Safety Reporting and Protocol Deviations:
      • Implement processes for accurate and timely reporting and follow-up of Adverse Events (AEs)/Serious Adverse Events (SAEs) and protocol deviations.
      • Oversee the CRA team in ensuring protocol compliance and escalating quality issues.
    6. Manage Trial Master File (TMF) and Site File Compliance:
      • Develop and enforce procedures for maintaining complete and accurate Trial Master Files (TMFs) and Investigator's Site Files (ISFs).
    7. Lead Patient Enrollment and Investigational Product Management:
      • Develop and monitor strategies to meet patient enrollment targets and project timelines.
      • Oversee the proper handling, accountability, and reconciliation of all Investigational Products (IPs) and clinical study supplies.
    8. Manage Communication and Reporting:
      • Develop and manage communication plans for all stakeholders, including investigators, sponsors, and internal departments.
      • Oversee the timely and accurate reporting of clinical trial data and progress.
    9. Manage Site Finances and Audits:
      • Oversee and coordinate hospital/investigator invoicing, payment, and financial reporting.
      • Lead the team in preparing sites for audits and addressing any audit findings efficiently.
    10. Manage Quality Management:
      • Review and address internal co-monitoring and sponsor audit reports.
      • Collaborate with the Quality Management Department for sponsor report review and response.
    11. Manage Nonconformity Reporting:
      • Implement and oversee procedures for nonconformity reporting and corrective action/preventive action (CAPA) processes.
  • Required Skills:
    1. Bachelor's degree in a life science field, such as biology, pharmacy, or nursing….
    2. Requires at least 5+ years of on-site independent monitoring experience
    3. In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
    4. Strong therapeutic and protocol knowledge as provided in company training.
    5. Excellent leadership, communication, and interpersonal skills to manage and motivate a team.
  • Application deadline: 2024-05-31

    • Apply now