Chemistry Laboratory Study Associate Vacancy @ GSK - Apply Online

Chemistry Laboratory Study Associate Vacancy @ GSK – Apply Online

GSK Hiring candidates with bachelor’s degree in science. BSc Chemistry job opening 2022. Chemistry Laboratory Study Associate vacancy. Laboratory Study Associate job opening 2022. Candidates with bachelor degree in science may apply for the job opening at gsk. Check out all the details on the same below:

Job Title: Laboratory Study Associate

Location: Bengaluru, India

Department: Medical and Clinical

Id: 342777

Education

Bachelor’s degree in sciences or equivalent background

Knowledge

  • Demonstrated knowledge and competency in laboratory processes and extended knowledge of ICH-GCP/GCLP rules
  • Demonstrated fluency in spoken and written English beyond scientific English
  • Good holistic view especially to proactively detect problems and define possible solution and/or to surface issues to Management.
    Knowledge and experience of using electronic clinical trial master file (eTMF) systems and associated business processes
  • Knowledge of Trial Master File industry accepted standards, such as the DIA Reference Model
  • Proven record of being customer driven and providing effective consultation and training
    Self-starter, able to work independently, as well in matrix team environment
  • Be able to demonstrate a flexible, proactive, diligent, and self-motivated approach to work

Experience

  • At least 2 years of operational experience in clinical laboratory activities and clinical study conduct
  • Proven experience in clinical project planning, project management and issues resolution
  • Experience of GSK clinical development processes and ability to quickly integrate global network to build strong partnership with their customers
  • Experience of managing business remote matrix network of internal and external stakeholders of multicultural and multidisciplinary people with different expertise and various scientific background
  • Ability to align all the parties involved to build alliances and influence across national and cultural boundaries (up to 20 in different countries, including Africa and China)
  • Experience in leading various operational meetings
  • FDA or other competent authority inspection exposure

Job Description: 

As a Lab Study Associate, you will be responsible for providing electronic Trial Master File (eTMF) support for assigned clinical trials and management of eTMF records, with a focus on the laboratory-related documents required for a study eTMF during study set-up, study conduct, and study close-out. Working with study teams, Laboratory Study Managers in particular, to establish study-specific eTMF structure and to ensure the quality of eTMF and eTMF content, according to the established processes.

Key Responsibilties: 

  • Support the collection and storage of study specific documents that are required for the Electronic Trial Master File (eTMF).
  • Ensures the clinical trial documentation is conducted in accordance with GSK written standards, work instructions and ICH/GCP guidelines
  • Ensures the TMF is inspection ready and in alignment with the study agreed strategy and applicable milestones (with a focus on the laboratory section of the eTMF)
  • Monitors and drives TMF completeness and quality for in-house and outsourced studies (laboratory section specifically)
  • Ensure laboratory documents maintained in the eTMF are appropriate and the content of those documents are accurate, complete and consistent with GSK written standards and regulatory requirements.
    Co-ordinate study archiving activity.
  • Work in close collaboration with the Lab Study Managers.
  • Provide support in the set-up of specific meetings with internal as well as external members.
  • Creation, review, maintenance and tracking of clinical trial documentation related to lab activities.
  • Providing support in the set-up and follow-up of operational laboratory related activities (status on lab supplies, sample tracking…).
  • Ensuring quality check/double-check on specific procedures.

Apply Online

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