Investigator

Site Name: USA - Pennsylvania - Upper Providence Posted Date: Apr 27 2022 Are you looking for an exciting opportunity to make an impact in the field of biology research development? If so, then this role is for you! The Human Biological Sample Management (HBSM) specialist will work within a central team playing a fundamental role in minimizing exposure of GSK R&D to legal and reputational risk associated with HBSM. The team supports research groups across GSK with respect to the ethical acquisition and/or use of Human Biological Samples (HBS) both within GSK R&D sites (internal HBSM) and by GSK's external partners (e.g. collaborations & alliances) working on behalf of GSK R&D at external institutions (external HBSM). The team drives the further development of the HBSM due diligence infrastructure including refinement of its business processes and IT tools. The team supports the HBSM Board in managing the overall strategy for HBSM risk management for R&D. Such activities include setting the priorities for reviews of the Human Subject Research (HSR) Policy and HBSM SOP and managing resolution of HBSM related escalations. This role has specific responsibilities relating to legal and ethical obligations for GSK worldwide. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Have comprehensive understanding of the GSK HSR Policy and HBSM SOP including HBS classification Provide HBSM advice to GSK scientists across the various research sites upon request Manage requests for HBS acquisition / use from R&D scientists (internal & external HBS) and perform appropriate due diligence according to GSK HSR Policy & HBSM SOP and local HBSM Team Guidance Provide GSK scientists information regarding any restrictions which apply to their requested HBS and give advice / support to correctly register and track their HBS at a GSK site Roll out training in HBSM operating procedures, including sample management and tracking tools Manage HBS Commercial suppliers (due diligence and ongoing oversight / monitoring) Maintain a database of HBSM information regarding all the above HBSM activities Support the management of the GSK Risk Treatment Plan(s) ensuring that each of the Internal Control Framework elements is embedded and activities completed as applicable May hold key HBSM roles for GSK R&D, including: HBSM representatives coordinator / site lead Responsibilities for CAPA management, risk register, audit preparation, external regulation engagements Responsibilities within HBSM Acquisition team, Genetics Advisory Panel, Restricted HBS application process, Risk Management Team Liaison / point of contact for external Research Ethics Committees or Independent Review Boards Engagements with key business partners (e.g. Worldwide Business Development, GSK Corporate Policy Office, Third Party Resourcing) Make key contributions to the overall HBSM strategy across R&D Competencies and Capabilities Shows a consistent focus on compliance and seeking to deliver and perform with excellence in all tasks. Challenges and questions ways of working to seek improved process. Seeks to raise levels of performance by establishing or improving process Able to foster strong matrix working Capable of developing and recommending strategies for change Good communication skills. Capable of delivering key communications with clarity and impact Strong skills developing personal networks and capable of using them to secure appropriate support and outcome Capable of identifying project or team issues in advance and seeking necessary help and support to resolve Ability to make sound decisions Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in life sciences Experience of the drug discovery and development process, with particular emphasis on considerations for the use of human biological samples Experience with the Internal Control Framework, its application and administration within the research setting Expertise in IT tools, systems and processes suitable to document management, record keeping and data retention for auditing purposes Experience and aptitude in sample tracking systems such as HEART would be beneficial Experience of engagement with internal and external decision-making bodies such as regulatory authorities, ethics committees, governance boards and committees Knowledge of the relevant laws and regulations of the principal nations in which GSK operates R&D would be beneficial Preferred Qualifications: If you have the following characteristics, it would be a plus: Masters Degree or PhD Experience with more advanced analytical techniques in biology Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigor and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations. 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