Principal Study Operations Manager

Site Name: USA - New Jersey - Warren Posted Date: May 9 2022 Why Consumer Healthcare? In GSK Consumer Healthcare, we are on an incredible journey as we prepare to create a new, standalone, world leading company with a 100% single-minded focus on everyday health. We are doing this at a time when the work we do has never mattered more. With the COVID pandemic, people are increasingly looking for ways to manage their own health and wellbeing and to take care of their families. This is where we come in. With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we are uniquely placed to deliver better everyday health to millions of people around the world and grow a strong, successful business. Clinical Operations plays a critical role in this mission, as we provide innovative operational expertise for the planning, management and delivery of clinical trials, in order to generate reliable scientific evidence which supports our pipeline of new products and maintenance of existing brands. The Principal Study Operations Manager is at the heart of our Evidence Generation activities. The role provides operational leadership to the Clinical Study Team and is responsible for the planning, management, execution, and delivery of the trial. The role will require a robust use of project management tools and operational practices. This role will provide YOU the opportunity to lead key activities to progress YOUR career and help us through our transformation. These responsibilities include some of the following: Study Team Leader and primary operational contact for 1-3 trials of average design and protocol complexity, including clinical trials, behavioral studies, and decentralized/virtual trials. Trials are managed in North and Latin America. Has the ability and agility to manage the delivery of any types of studies (complex/ unusual study designs, new indications, challenging regional environment and local regulations) and strategically influence the operational delivery Responsible for the implementation, conduct and tracking of study trials in compliance with ICH/GCP and local regulations, company SOPs and written standards for the conduct of human subject research, study timelines, within budget and to project specifications. Provides operational and strategic leadership to assure successful delivery of trials. Acts as Business Owner and performs oversight of clinical sites, third parties/CROs and vendor activities according to the Functional Service Provider (FSP) or Full-Service Outsourcing (FSO) models Lead the coordination of cross-functional department activities to successfully achieve milestones and quality deliverables in study management, including but not limited to study start-up, recruitment, study conduct, and database lock and study close-out with risk and issue management and assurance of TMF inspection readiness. Contributes to the plans and study documents from an operational standpoint, such as protocols, informed consent forms, monitoring plans, vendor contracts, clinical study reports, etc. Leads or participates in clinical site assessments, vendor and due diligence/audit activities, and provides subject matter expertise on business improvement initiatives and change implementation. Mentoring of peers 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 5 + years experience in managing clinical research studies, clinical operations or equivalent Project management experience 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 Demonstrated business acumen, team leader experience either directly and/or as a matrix organization, as well as representing an organization with external stakeholders, including for example, Contract Research Organizations, Investigational Sites, Healthcare Organizations and External Experts Experience in RWE (Real World Evidence), decentralized trials appreciated Why Consumer Healthcare? Right now, we're on an incredible journey as we prepare to become the first independent, 100% focused consumer healthcare company. We're doing this at a time when the work we do has never mattered more. Better everyday health is about improving the health and wellness of the consumers that we touch every year - over a billion and a half of them - and it goes beyond products. It's about truly helping people manage their health proactively in different ways as consumer needs evolve. With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we're uniquely placed to do this and to grow a strong, successful business. This is an exciting time to join us and help shape the future. It's an opportunity to be part of something special. Diversity, Equity and Inclusion In Consumer Healthcare we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. *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. 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