Site Name: Home Worker - USA

　　Posted Date: Nov 29 2023

　　Are you energized by the opportunity to partner with key leaders in global medical science to enhance global operational support. If so, this Local Delivery Lead could be an exciting opportunity to explore.

　　The Local Delivery Lead provides leadership, oversight and manages the activities of within-country operational planning and delivery of Phase I-IV clinical trials in a specific country or cluster of countries: across all therapy areas (Rx and Vx) to the required quality standards, GSK written standards, local regulations and ICH GCP.

　　This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...

　　Leads the local study team consisting of within-country clinical operations team members, cross functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff and external clinical site staff involved in study preparation and delivery, providing both matrix leadership and project management of study activities within the country/countries.Serves as the operational point-of-contact between the central GSK study team and within-country study team. The LDL collaborates closely with local medical and regulatory affairs staff to align on local medical and scientific requirements. As required, collaborates with the local and above-country teams for conducting study feasibility and site selection within countr(ies).Accountable for within-country delivery of assigned studies to time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations, IND/GCP/ICH guidelines, GSK Corporate, Vaccines, and local SOPs and POLs.Ensures that critical study timelines related to study activities within-countr(ies) are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit qualities are met. Provides troubleshooting and problem resolution support for within-country study team to ensure productive, efficient study delivery.Accountable for the accuracy of study systems, including completeness of the trial master file, and reporting study delivery progress to study team and key stakeholders.Identifies and resolves or escalate risks and issues that may impact study delivery.Provides feedback on performance, capabilities and competencies of study members to line management. As required, reviews and approves monitoring visit reports and ensure appropriate site monitoring activities have been completed per the study monitoring plan.Has the accountability to estimate, track and deliver against the local budget for the studies within their scope of responsibility.As required, advises on contract development with Sites/CRO/Vendors and may participate in budget/contract negotiations with study vendors or clinical investigator sites.As required, prepares the local Informed Consent Form and coordinates the submission of Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs). Maintains communication with RA and ECs to ensure all regulatory requirements are met in a timely manner throughout the study.Acquires and maintains an appropriate level of knowledge on the study compound, protocol, pathology of disease area being studied, competitive landscape within country/countries, local treatment/immunization guidelines and local health care system requirements.As required, assists with audits/inspections of local clinical operations department & study / sites in the country.Continuously develops knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring, site and project management skills and capabilities. Responsible to identify and share best practices.Available and willing to travel as job requires. Why you?

　　Basic Qualifications:

　　We are looking for professionals with these required skills to achieve our goals:Bachelor's degree5 or more years of project management experience within the pharma industry5 or more years' Experience providing operational support across global scientific and medical functions.Preferred Qualifications:

　　If you have the following characteristics, it would be a plus:Advanced Degree in Life SciencesStrong stakeholder management experienceProven ability to influence and build consensus. Why GSK?

　　GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

　　Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

　　 #LI-GSK

　　The annual base salary for new hires in this position ranges from $114,563 to $154,997 , taking into account a number of factors including work location, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

　　Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.

　　Why Us?

　　GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

　　Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

　　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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