1+ months

Sr. Clinical Research Manager

Abbott
上海, Shanghai

Primary Job Function:

The leader of clinical operation team; responsible for the establishment optimization of quality management system for clinical study projects in China. Responsible for operational conduct of clinical study projects (in interaction with the Clinical Research Organization (CRO) Project Manager) and to manage the interaction with various Abbott specialists of the clinical team and medical team to ensure the completion of study objectives in accordance with the applicable regulations in China. The scope of clinical projects includes but is not limit to phase IIV study, clinical pharmacology studies, bio-analytical studies, epidemiology study, and medical research in China. Responsible for providing clinical development expertise to business development team and project teams on clinical development programs for potential product candidate and supporting branded generics plans or ITBs to expand or maintain EPD compounds on the market in China.

Core Job Responsibilities:

1. The Leader of Clinical Operation Team:

  • As the line manager of Clinical Project Manager/Specialist, be responsible for goal plan setting, performance management for the clinical operation team.
  • Be responsible for project assignment, workload management for the team, and provide training and coaching to the team including ICH-GCP, SOP and interpretation to local regulations.
  • As the leader to have an overview management to all the planned and ongoing clinical study projects including project planning, budget, CRO bidding/selection, quality monitoring, internal communication

    2. Clinical Study Projects:

    • Conducts Clinical Study Projects from study start-up to final study report, including (Co-) monitoring, managing and/or coordinating in- and external resources per project basis and aligning activities to agreed timelines and deliverables.
    • Ensure the pharmacovigilance compliance to both company and local regulations for responsible clinical study projects in alignment with CROs.
    • Oversees and manages CROs and other second vendor activities (such as Study management, risk management, monitoring) and supports study budget controlling and tracks budget relevant milestones.
    • Organizes and coordinates outsourcing for activities related to clinical trial conduct like monitoring, Project Management, Medical Writing, Registration and follows-up on deliverables.
    • Acquire, maintain and share knowledge / expertise related to CTM and to project specific medical / scientific aspects; To provide insights from the sites of potential needs of protocol amendment to resolve problems to ensure on track deliverables.
    • Contributes to and/or advises on update of processes, guidelines and procedures relevant for Clinical Trial Management
    • Serve as a key contact for issue resolution and liaison between global team and China Affiliate.
    • Support to enable the quality management system including but not limit to vendor evaluation, internal QC, audit and inspection.

      3. Clinical Development Program

      • Responsible for providing clinical development expertise to business development team and project teams on clinical development programs for potential product candidate for China.
      • Supporting branded generics plans or ITBs to expand or maintain EPD compounds on the market in China.
      • Act as the Regional Project Manager in a regional project or product team on assigned projects.
      • Interacts with the Project Teams operating in this TA including Commercial, Regulatory Affairs, and other disciplines to ensure that the clinical project fulfills the regulatory requirements and represents the company to the Regulatory bodies as appropriate on clinical matters.
      • Performs other duties as assigned or requested.

        Minimum Education:

        - Clinical development background

        - Master degree in biological/pharmaceutical/chemical sciences or comparable level.

        - Excellent English

        Minimum Experience/Training Required:

        Minimum 5 years of experience in the pharmaceutical industry as Clinical Research Manager or Clinical Project Manager across different clinical development phases. Experience on clinical projects for Asia-Pacific Region is preferred.

        ","industry":"Healthcare","title":"Sr. Clinical Research ManagerDivision: EPD Established Pharma
        Travel: Not specified
        Medical Surveillance: Not Applicable
        Significant Work Activities: Not Applicable

Categories

Posted: 2020-03-25 Expires: 2020-10-22

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Sr. Clinical Research Manager

Abbott
上海, Shanghai

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