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clinical operation director/sd.

职位概述

职位概览

    职位概述

    MAJOR RESPONSIBILITIES:

    1. Oversee interdisciplinary clinical research programs.

    2. Represent WORG to CRO ensuring satisfaction levels are maintained and program deliverables are communicated effectively.

    3. Monitor and supervise performance and delivery of CRO key deliverables at all levels: Act in a preemptive manner.

    4. Ensure all studies within a program are conducted to reflect the therapeutic specific requirements.

    5. Apply study specific learning across assigned portfolio of studies/clients.

    6. Ensure and maintain an in depth therapeutic and/or client specific knowledge and expertise for the assigned portfolio.

    7. Contribute to the development of Clinical Development Plans.

    8. Ensure programs of studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements.

    9. Plan, coordinate and present at internal and external meetings including conferences and professional organizations.

    10. Participate in bid proposal meetings as required.

    11. Lead operational input to proposal development and pricing including proposed operations strategy at a program level.

    12. Drive performance improvement and operational efficiencies at a program level.

     

    EDUCATION REQUIRED:

    1. Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field equivalent preferred.

    2. Advanced Degree preferred Ideally Project Management qualified i.e. Prince II or PMP / equivalent.

     

    MINIMUM TRAINING & EXPERIENCE REQUIRED:

    1. 15 years relevant clinical research experience with an understanding of clinical drug development and clinical trials operations.

    2. 5 years oversight of clinical programs and/or managing clinical programs.

    3. Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.

    4. Strong organizational skills.

    5. Strong ability to manage time and work independently.

    6. Direct therapeutic area expertise.

    7. High proficiency with full MS Office Applications, including MS Project.

    8. Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence,convince, and persuade.

    9. High level of competence in English language.

    10. Ability to travel as necessary (approximately minimum 25%).

    11. Experience in Allergy field useful.

    MAJOR RESPONSIBILITIES:

    1. Oversee interdisciplinary clinical research programs.

    2. Represent WORG to CRO ensuring satisfaction levels are maintained and program deliverables are communicated effectively.

    3. Monitor and supervise performance and delivery of CRO key deliverables at all levels: Act in a preemptive manner.

    4. Ensure all studies within a program are conducted to reflect the therapeutic specific requirements.

    5. Apply study specific learning across assigned portfolio of studies/clients.

    6. Ensure and maintain an in depth therapeutic and/or client specific knowledge and expertise for the assigned portfolio.

    7. Contribute to the development of Clinical Development Plans.

    8. Ensure programs of studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements.

    9. Plan, coordinate and present at internal and external meetings including conferences and professional organizations.

    10. Participate in bid proposal meetings as required.

    11. Lead operational input to proposal development and pricing including proposed operations strategy at a program level.

    12. Drive performance improvement and operational efficiencies at a program level.

     

    EDUCATION REQUIRED:

    1. Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field equivalent preferred.

    2. Advanced Degree preferred Ideally Project Management qualified i.e. Prince II or PMP / equivalent.

     

    MINIMUM TRAINING & EXPERIENCE REQUIRED:

    1. 15 years relevant clinical research experience with an understanding of clinical drug development and clinical trials operations.

    2. 5 years oversight of clinical programs and/or managing clinical programs.

    3. Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.

    4. Strong organizational skills.

    5. Strong ability to manage time and work independently.

    6. Direct therapeutic area expertise.

    7. High proficiency with full MS Office Applications, including MS Project.

    8. Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence,convince, and persuade.

    9. High level of competence in English language.

    10. Ability to travel as necessary (approximately minimum 25%).

    11. Experience in Allergy field useful.