þasibility Manager

Site Name: Warsaw Posted Date: Jan 27 2023 We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated. In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention. Find out more: Our approach to R&D. Would you like to enhance your clinical systems expertise with an opportunity to accelerate compliance and efficiency across clinical operations? If so, this Clinical Support Manager role could be an excellent opportunity to explore. As a Clinical Support Manager, you will be responsible for understanding how well a study is progressing, driving the clinical trial systems completeness. You will serve as point of contact for the study teams for clinical trial system matters and liaise with clinical systems Subject Matter Experts (SMEs) Feasibility Manager In this role you will… Ensure that the clinical system is inspection ready and in alignment with the study agreed strategy and applicable milestones. Ensure the clinical trial documentation is consistent with trial master file agreements and applicable Standard Operating Procedures (SOPs), International Council for Harmonization (ICH), Good Clinical Practices (GCP). Provide project management expertise to Study Accountable Person (SAP) and their study team members globally as needed to support their study deliverable targets, to agreed quality and data integrity standards Serve as point of contact for the study teams for Clinical System matters and liaise with Clinical System Subject Matter Experts (SMEs) and process owners to ensure trial master files are inspection ready Conduct analysis and identification of business problems/opportunities that may arise and support the implementation of high quality solutions Address requests in a timely and efficient manner and assist in the development and delivery of training materials at the study level providing subject matter expertise Understand all technical aspects of Pharma Clinical system and associated tools Liaise with third party providers, performing as part of the cross-functional team Ensure that the documents are filed to meet the required timelines and the Analyst would ensure there is no deviation from the plan and follow up appropriately Monitor and identify trends for studies and drive the clinical system completeness metrics, track performance Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Associate degree 3 or more years of experience using clinical trial systems and associated business processes Experience with electronic document management and industry accepted standards Preferred Qualifications: If you have the following characteristics, it would be a plus: Bachelor’s degree Excellent working knowledge of International Conference on Harmonization/Good Clinical Practice (ICH/GCP) Excellent communication and interpersonal skills 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. 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. Find out more: Annual Report 2021
LI-GSK
LI-HYBRID 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 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/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/ Agencies GSK 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 GSK’s Transparency Reporting For the Record site.