Investigator

Employer
GSK
Location
Collegeville, Pennsylvania
Salary
Competitive
Closing date
May 25, 2022

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Sector
Pharmaceutical
Organization Type
Corporate
Jobseeker Type
Professional
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. Budgeting and cost-consciousness *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

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