Manager, Clinical Studies - Supplies
Site Name: Richmond Sherwood Posted Date: Jun 1 2021 The Manager, Clinical Studies - Supplies is responsible for the operation of Clinical Supplies function of GSK Consumer Healthcare. In this role you will design, develop and implement operational plans, administrative programs and production strategies that refine operations, enhance efficiencies and ensure services consistently meet or exceed quality standards. You will screen, hire, train, motivate and evaluate employees of the department. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Work across departmental boundaries as Clinical Supplies expert to build efficient and collaborative ways of working with partners in R&D Categories, Clinical Development, Quality, Global Development Operations, Regulatory Affairs and Marketing. Accountable, through Clinical Supplies team that clinical trials materials are sourced, labelled, packed and shipped following cGMP and compliant with ICH/GCP and FDA regulations, CH SOPs and international shipment regulations to meet category clinical plans Responsible for contract documentation and management of budget for delivery of clinical trials supplies through 3rd party outsource providers Lead and support audits through GSK internal audit teams and external regulatory bodies, closing out audit actions as assigned to ensure departmental compliance Maintain compliance to internal procedures, update SOP and WIs as per periodic review or driving changes to process, complete Management Monitoring Audits as per assigned schedule and champion compliance across team Lead continuous improvement initiatives internally and act as a team member on cross functional improvement initiatives with Global Development Operations, Clinical Development and other partners as required as part of integration and future spin of new CH business from GSK. Perform forecasting, strategic planning and establishing goals for the department. Implement policies, mandates and standards for producing cGMP compliant products to meet the goals of the business. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor of Science degree 10 + years of experience / background working within a clinical trials or human use study-related field, or a Master of Science degree with 7 + years of relevant experience Experience within a Clinical Supplies role with strong knowledge of global regulations in human use investigational products and application to clinical trials 5 + years of people-management experience required Preferred Qualifications: If you have the following characteristics, it would be a plus: Strong project management with proven record of delivering multiple projects simultaneously ensuring correct prioritization of work Able to work and develop relationships with business partners across departmental and geographical boundaries Ability to build relationships with outsource providers to ensure department can meet and match demand for clinical study delivery Strong interpersonal skills, building and developing capability within others and acting as a leader and mentor. 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: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *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. 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