Sr. Clinical Study Manager
Site Name: USA - New Jersey - Warren Posted Date: Jul 13 2021 In support of the Clinical Development IPT values (Innovation, Performance, Trust), the Senior Clinical Study Manager is accountable for the execution and delivery of the study to timelines, budget and quality as defined in the Non-Clinical and Clinical Development Plan and study protocol, and in adherence with GCP-ICH guidelines, GSK Consumer Health (CH) Written Standards and within regulatory requirements. The role will involve leading and managing a clinical study team using robust project management tools and operational practices. This role interacts with internal teams, as well as external groups and individuals, such as Investigational Sites, Contract Research Organizations (CRO) and others as needed, to help achieve company objectives and to build GSK reputation. Demonstrates the GSK expectations of Courage, Accountability, Development and Teamwork This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Study Accountable Person for assigned clinical study projects Accountable for the implementation, conduct and tracking of clinical trials, according to study timelines, within budget and to project specifications. Provides operational and strategic advice regarding study conduct and logistics. Ensures appropriate study oversight including study kick off meeting(s), communications, regular interactions/meetings with Third Parties, review of protocol deviations, risk and issue management and ensures appropriate follow-up actions are taken. Conduct and oversight of clinical / human subject research studies, including oversight of CROs and clinical sites according to the Functional Service Provider (FSP) or Full Service Outsourcing (FSO) models. Strong operational leadership of cross-functional clinical study teams. Lead or contribute to the creation and execution of effective study delivery plans aligned with project goals and timelines. Ensures studies are conducted in compliance with ICH/GCP and local regulations, GSK enterprise and Consumer Health SOPs and other written standards for the conduct of human subject research. Subject matter expertise on implementing good clinical practice and evolving trends in clinical operations. Deliver in alignment with GSK values and expectations. Tracks delivery to time, cost and quality, including maintenance of standard tools such as, eTrack, Finance Tool and MSProject. Oversight of human biological sample management within clinical development and acts as HBS custodian. Accountable for the TMF-related activities from study start-up to archiving, in order to ensure the TMF is high quality and inspection ready at all times. Represents Clinical Operations in Clinical Development and provides subject matter expertise on improvement initiatives and change implementation. Leads or participates in clinical site assessments, vendor and due diligence activities. Typically, responsible for 1-3 trials of average design and protocol complexity, including clinical trials, behavioral testing and decentralized/virtual trials. Trials are managed in North and Latin America. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in Science or Health-related field 3+ years experience in managing clinical research studies, clinical operations or equivalent. Experience and understanding of clinical research and clinical trial management, associated regulatory processes, and quality requirements. Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced Degree in Life Sciences Track record of success in continuous improvement, innovative work practices and driving changes to achieve these Demonstrated team leader experience either directly and/or as a matrix organization Demonstrated experience representing an organization with external stakeholders, including for example, Contract Research Organizations, Investigational Sites, Healthcare Organizations and External Experts Demonstrated business acumen. 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, rigour 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 *This is a job description to aide in the job posting, but does not include all job evaluation details. *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). 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