GSK

Senior Clinical Study Manager (BB-74455)

Found in: Neuvoo CN

Description:

Are you energized by an opportunity to accelerate and deliver clinical safety and compliance across multiple clinical programs? If so, this Clinical Development Manager role could be an exciting opportunity to explore.

As a Clinical Development Manager, you will participate in Phase I-IV Clinical Development and Epidemiology activities within a program or group of related programs to ensure the high quality and on-time delivery of scientific data.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Participate in Clinical Development and Epidemiology activities for a study or studies within a specific program or group of related programs.

• Design clinical trial and epidemiology study protocols, and author study reports and publications of high scientific, operational and ethical standards under the supervision of an experienced senior Clinical Research Development Lead (CRDL), senior Epidemiologist or Clinical Epidemiology Program Lead (CEPL).

• Responsible for scientific and medical quality and timeliness of clinical trial synopses and protocols and all clinical trial documents, including Investigator’s Brochure and the Study Report.

• Supervise the study conduct and serve as the accountable for the overall delivery of clinical and epidemiology trials and as a scientific and management reference for the project (internally/externally).

• Support the Senior CRDL, Senior Epidemiologist or CEPL in representing therapy area in meetings with health authorities and the scientific community where applicable.

• Assemble and transmit timely summaries of clinical safety data for review by the competent medical officer and publish clinical and epidemiology data in peer review journals and presents in external scientific meetings/congresses.

• Responsible for Data Listing review for the medical portion of data listing for individual studies and assuring medical consistency within a trial and across trials within program.

• Address scientific and medical issues related to one or more clinical/epidemiology studies paying special attention to serious adverse events and potential safety signals and ensures study results meet the highest standards of quality and ethical conduct.

• Liaise with the Regional Evidence Generation and the Local Medical Leads to ensure alignment of clinical/ epidemiology trial activities (includes but not limited to, scientific and medical issues as well as subjects safety).

• Actively participate in preparing the clinical portion of the regulatory files and the registration process and contributes to development of clinical section of regulatory files, including labelling.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • Master’s degree
  • Direct experience with Good Clinical Practices (GCP), Good Epidemiology Practice (GEP), regulatory guidelines
  • Experience overseeing the medical and human safety aspects of clinical programs
  • Preferred Qualifications:

    If you have the following characteristics, it would be a plus:

  • PhD or Doctor of Medicine (MD)
  • Experience independently conducting clinical research, critically evaluating scientific aspects of immunology
  • Ability to work in matrix environment and multi-task through good planning and organization skills
  • Effective ability to prioritize tasks and deliver on deadlines
  • Ability to translate scientific skills in clinical research into business-driven strategies
  • calendar_today16 hours ago

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    info Full time

    location_onShanghai, China

    work GSK

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