QED Pharmaceutical Services
Quality and Ethics in Data
Head, Clinical Operations

Provides medical expertise for site identification, study feasibility, study design, conduct, analysis and reporting, generation of integrated databases, pooled analyses for efficacy and safety, ISE and ISSs, dossiers for regulatory submissions for market authorizations of new medicinal products, and diagnostics and devices.

Job Responsibilities
  • Lead/develop/determine

    • Feasibility studies, plan ,questionnaires and results
    • Investigational sites and countries
    • Discussions with regulators/investigators/internal and external clients/project team
  • Support

    • Study design, generation of study protocol, investigator brochure
    • CRF, informed consent, statistical analysis plan , other study material
    • Selection and recruitment of investigational sites
    • Generation of publications and expert reports
    • Business development
    • To identify, acquire and win new business (by providing medical expertise)
    • To discuss portfolios and development strategies (through client contacts)
  • Develop (for the conduct of the clinical trial)

    • Case Report Forms
    • Source document templates
    • Regulatory templates
  • Provide

    • Continuous medical monitoring during study conduct
    • Answers to questions on protocol
    • Evaluation of AEs and SAEs
    • Therapeutic training relevant to specific study and project team
    • Options for different approaches to patient recruitment, referral systems and operational execution
  • Review

    • Laboratory and patient data
    • Codes of medical history
    • Concomitant medications, AEs and SAEs
    • Safety management plans
    • Regulatory reporting requirements
    • Notification letters to regulators/investigators/IRBs
    • Data summaries for Data Monitoring Committees
    • Annual study/safety reports, waiver applications
    • Correspondences to health authorities/investigators/clients/third parties
  • Establish/maintain

    • Safety systems and database including SOPs
    • Metrics and tracking systems
    • Relationships with new customers
    • Existing client relationships to obtain repeat business
  • Promote QED through active involvement in

    • Scientific meeting and speaking engagements
    • RFP discussion with clients
    • Bid defense meetings including generating presentations

  • Licensed physician (MBBS or higher) with advanced degrees (MD or DNB) in Clinical Pharmacology
  • Clinical research or drug safety experience required
  • Experience writing pharmaceutical or health-related documents required
  • Experience writing clinical study reports, poster presentations, and manuscripts for publication in a scientific journal preferred
  • Knowledge of regulatory requirements preferred
  • Outstanding verbal and written communications skills required
  • Project leadership/management skills preferred
  • Experience using computerized systems (PC-Windows and MS Office)