Clinical Project Manager (CPM)

по договоренности
Москва
Опыт от 3 до 6 лет

Job Responsibilities:

  • Takes overall responsibility for the study delivery in Russia
  • Provides project’s milestones and deliverables oversight for up to 10 clinical studies with different types of funding depending on incoming study workload
  • Provides functional oversight for contract CRAs during validation, initiation, routine, close-out monitoring activities; review of monitoring visits reports, proposes and follow-up the implementation of corrective and preventive actions by CRAs, provides feedback on performance if required
  • Ensures that studies are performed in compliance with ICH/GCP, Company global standards, local SOPs, laws and regulations. Conduct quality co-monitoring visits
  • Maintains a therapeutic area investigators database
  • Continuously participates in relevant training courses to improve personal/professional skills, provides study- and GCP-specific training to CRAs, CTCs and/or relevant Company staff
  • Participates in local, regional and global non-protocol related activities
  • Cooperates with colleagues from other departments to support local product registration and approved promotion activities
  • Reports on fraud or scientific/ethical misconduct as appropriate
  • Contributes to development and improvement of departmental procedures and processes in the scope of the company’s effort towards continuous quality improvement
  • Provides timely input and update of relevant clinical study databases depends on study period
  • Serves in clinical trials as point of contact for internal and external stakeholders. Works internally with PV, Regulatory, and Global Medical Affairs to align on key decisions
  • Works with external investigators, vendors, and contractors to ensure consistency across organization. Participates in knowledge generation across industry
    • Work Environment:

    • Competitive compensation, salary rate is under discussion
    • Medical insurance
    • Car allowance
    • Office-based work
      • Requirements:

      • Master's Degree preferably in Medicine or equivalent Health Care related experience
      • It is desirable that the candidate has not less than 5-6 years of experience in CR, including monitoring and project management
      • Strong scientific and clinical knowledge, an understanding of clinical trial planning and management
      • Fluency in English language
      • Superior oral and written communication in an international environment
      • Excellent project management and organizational skills
      • Strong leadership skills (scientific and business), ability to lead across several dimensions simultaneously
      • Ability to think strategically and objectively and with creativity and innovation
        • Тип занятости:

          Полная занятость, гибкий график, у работодателя

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