Scientific Operations Investigator

3 weeks ago

Stevenage, Hertfordshire, United Kingdom GlaxoSmithKline Full time
Job Title: Investigator, PMed Scientific Operations

We are seeking an experienced Investigator to join our PMed Scientific Operations team. As an Investigator, you will be responsible for providing operational management of biomarker and companion diagnostic activities in clinical trial assay development, clinical trial setup, execution, and closeout, external vendor management, and collaborations.

Key Responsibilities:
  • Implement operational delivery of biomarker strategies developed by Clinical Biomarker and Virology leads within clinical trials.
  • Work with Associate Directors to ensure program-level operational strategy is deployed within studies assigned.
  • Accountable for operational deployment of sample management strategy, ensuring all activities are completed within time, quality, and budget requirements and aligned with agreed program sample management strategy.
  • Provide expert input into Clinical Trial documentation, including protocols, informed consent forms, data transfer agreements, lab manuals, and central lab specifications, to ensure scientific operational aspects are fit for the intended purpose.
  • Ensure alignment of biomarker outputs with Data Management, Biostats, and modeling/simulation requirements. Provide expert input into data transfer agreements.
  • Work with Clinical Operations to draft Site Communications and Training Materials; train CRO and internal teams on sample collection/processing activities as required.
  • Accountable for identification, documentation, and management of risks within assigned projects with the associated Associate Director for the program.
Requirements:
  • Bachelor's degree in a science or health-related discipline.
  • Experience in clinical trial specimen management, including collection and processing of diverse sample types, laboratory management, LIMS, and project management.
  • Knowledge and understanding of the clinical development process, GxP, and global regulatory requirements.
  • Excellent communication skills and good interpersonal and matrix working skills.
  • Self-motivated with the ability to work independently as well as a highly motivated team player with a proactive attitude and ability to interact effectively within a multi-disciplinary team, including internal and external technical and business experts.
Preferred Qualifications:
  • Master's degree or equivalent experience.
  • Demonstrated knowledge of Chinese regulatory requirements and expectations for sample analysis, including sample exportation.
  • Experience with validation and implementation of biomarkers.

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