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Sponsor (Opérations cliniques (ClinOps) affaires clinique (Adjoint de…

- - - - • writing drug trial methodologies (procedures)
      - • identifying and briefing appropriate trial investigators (clinicians)
      - • setting up and disbanding trial study centres
      - • designing trial materials and supplying study centres with sufficient quantities
      - • providing clinicians with instructions on how to conduct the trials
      - • collecting and authenticating data collection forms (commonly known as case report forms)
      - • monitoring progress throughout the duration of the trial
      - • writing reports
  - - - • Oversee CRA activities and ensure Trial Site oversight/management is adequate
      - • Collaborate with cross-functional groups (Data Management, Regulatory, Product Safety, etc) to execute/manage/develop protocols
      - • Manage Trial Site contracts and budget negotiations
      - • Manage study timelines, budgets and deliverables
  - - - • Maintain Trial Master Files (TMF)
      - • Maintain Clinical Trial Management Systems (CTMS)
      - • Create/maintain trackers for study management
      - • Draft meeting minutes and coordinate clinical study team meetings
- - - - • Ensure proper safety data reporting per reporting requirements
      - • Assist with Serious Adverse Events (SAE) reconciliations
      - • Maintain clinical safety database
- - - - • Discuss Trial Subject safety management
      - • Assess adverse events and their relationship to the investigational product
      - • Analyze safety and efficacy data for scientific reports
- - - - • Responsible for all statistical aspects of the clinical protocol
      - • Analyze and report on clinical trial data
      - • Provide statistical consultation for clinical protocol design, conduct, efficacy evaluation and data review
  - - - • Design/validate/maintain clinical database
      - • Review data in clinical database with regard to quality and integrity
      - • Generate queries to the site regarding non-conformant data or data requiring clarification
      - • Train site personnel and provide data entry guidelines
- - - - • Author/review SOPs
      - • Assist/conduct study/site audits
      - • Serve as resource for study team with regard to compliance per regulations/guidelines
- - - - • Prepare/assist submissions packages for regulatory authorities
      - • Author/review study documents such as Protocols, Informed Consents, Investigator Brochures, etc.
      - • Review study- and site-level regulatory documents for completeness/accuracy per regulations/guidelines