Clinical Operations
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    发布时间:2020年08月31日  


    Senior Manager/Associate Director


    Job Responsibilities:

    1. Plan and deliver the assigned projects with high quality, and in accordance with  program/company goal, including project timelines, risk assessments, and budgets etc

    2. Ensure study conduction in compliance with ICH-GCP, country specific regulations, Standard Operating Procedures (SOPs), study specific plans and guidelines

    3. Coordinate project related 3rd party vendors selection (CRO, SMO, central lab etc.) and oversee the vendor performance throughout the study

    4. Manage internal and external clinical development activities with team members involved in the design and conducted of clinical trialsAssists with protocol design and medical issue resolution; Work closely with CMC function to ensure the timely supply of clinical trial drugs

    5. Develop study related documents/plans in collaboration with the CRO, including consent form, protocols, statistical analysis plan, clinical study reports and operational plans, etc.

     

    Qualifications:

    1. Bachelor degree or above in life sciences, pharmacy, or medicine related majors

    2. At least 5 years of clinical research or relevant experience; Neurology/pain clinical trials experiences preferred

    3. Fully understand and be familiar with the application of GCP and ICH guidelines

    4. Excellent project management skills with sense of responsibility and teamwork spirit

    5. Good command of English, both in written and spoken, great communication and coordination skills

    6.Demonstrated business ethics and integrity.


    E-mail:hr@simrbio.com