Associate Clinical Study Manager

2 days ago

London, Greater London, United Kingdom GlaxoSmithKline Full time
Job Summary

We are seeking a highly skilled Clinical Study Manager to join our team at GlaxoSmithKline. As a Clinical Study Manager, you will be responsible for providing medical/scientific expertise in the safety evaluation and risk management of key GSK assets in clinical development and/or the post-marketing setting.

Key Responsibilities
  • Ensure scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate.
  • Make recommendations for the further characterization, management, and communication of safety risks.
  • Drive production of regulatory periodic reports and associated documentation and RMPs globally according to the agreed process and timelines; advises on content of regulatory period reports (in partnership with the product physician).
  • Author the SERM safety contribution to global regulatory submissions in partnership with the product physician.
  • Advanced evaluation skills and analytical thinking for literature review, data gathering, data synthesis, analysis and interpretation.
  • Make sound decisions based on relevant information or factors gathered from a broad range of sources, seeking help and input as needed.
  • Committed to the task and able to prioritise activities effectively and meet multiple deadlines successfully and with appropriate attention to detail, setting high performance standards for quality.
Requirements
  • Medical Doctor (physician) preferred, (or equivalent e.g. veterinarian/dentist with appropriate PV experience), with additional relevant medical or scientific post-graduate qualifications.
  • Pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities.
About Us

GlaxoSmithKline is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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