Principal Country & Site Activation Manager (Global Start Up Study Manager)

Job title:

Principal Country & Site Activation Manager (Global Start Up Study Manager)

Company:

GlaxoSmithKline

Job description

Principal Country & Site Activation Manager (Global Start Up Study Manager)The Country & Site Activation role is responsible for providing customer-focused execution of the operational strategy and management of start-up activities for studies but may also be assigned to manage whole programs of work. This includes the overall management and oversight of the following processes: country & site activation and regulatory approval. This role also has responsibility for maintaining internal tracking for study site status from initial site contact through site initiation. This position will primarily work with Local Delivery Leads in the LOCs, SDLs in Rx and Vx Delivery and the Feasibility Managers and GMASE SSU Teams.This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:Lead in the development and delivery of the global plan for country and site activationEnsures that critical study timelines related to Study Start-Up activities are achieved and that relevant cycle times, data and audit quality are metProvides troubleshooting and problem resolution support for department to ensure productive, efficient contribution to study deliveryMay act as the STOM working group lead dependent on experienceOversees day to day delivery of all aspects of global country site activation in the projects assignedEnsures that each project has a country and site activation plan and that country activations are planned in a single wave to maximise start up performance across all countries selected for a trialMeets the study timelines and expectations and complies with SOPs, reporting norms, appropriate regulations, and GSK’s quality standardsInput into project update and status calls, and other communicationsUtilize project management skills to optimize performance and collaboration to ensure successful study outcomes • Developing appropriate early warning systems of potential obstacles to the successful completion of study startup; analyses information and develops innovative solutions to challenges Responsible for escalation of issues and reporting progress to study teams and clinical management weekly, including plans for addressing/mitigating risks/gapsMaintains current knowledge of relevant country regulations, and GCP and ICH Guidelines for clinical researchContribute to process improvement efforts both within the department and in cooperation with other departmentsTransition oversight accountabilities to the SDL at the end of the start-up phase Job Description Description Other SkillsSignificant clinical operations experience preferably across multiple TAs and phases of development in Rx and VxHave worked in a Study Start Up or Country & Site Activation teamExperience analyzing data to optimize clinical trial delivery and to create various scenarios to support the operational design of a trialWhy you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Academic degree ( Business, Science or Math, Study Management, Clinical Operations or related discipline)Experience with electronic document management and industry accepted standardsSignificant clinical operations experience preferably across multiple TAs and phases of development in Rx and VxExperience of being a senior Study Start Up Lead/SSU Team Leader or have been involved with leading the delivery of clinical studiesExperience analysing data to optimize clinical trial delivery and to create various scenarios to support theWhy GSK?At GSK we offer a wide range of additional benefits:Career at one of the leading global healthcare companiesHybrid work ( 2/3 days per week from the office)Contract of employmentAttractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)Life insurance and pension planPrivate medical package with additional preventive healthcare services for employees and their eligible counterparts.Sports cards (Multisport)Possibilities of development within the role and company’s structure

Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities).Supportive community and integration eventsModern office with creative rooms, fresh fruits every day#LI-GSK#LI-HYBRIDAs an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at to discuss your needs.Why GSK?Uniting science, technology and talent to get ahead of disease together.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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).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.GSK is an Equal Opportunity/Affirmative Action Employer. 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.Important notice to Employment businesses/ AgenciesGSK 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 the Centers for Medicare and Medicaid Services (CMS) website at

Expected salary

Location

Warszawa, mazowieckie

Job date

Sat, 29 Mar 2025 06:09:11 GMT

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