Site Name: Mississauga Milverton Drive Posted Date: Oct 1 2024 Clinical Operations Planning & Feasibility Associate Director As R&D efforts follow science without constraint, we need to take full advantage of our internal data and expertise, as well as leverage external services and technology, to inform, optimize and validate our clinical trial protocols and study delivery plans. This includes the management of a robust site feasibility process. As such we are seeking to appoint a Clinical Operations Planning & Feasibility Associate Director to create data driven, high quality insights and modelling to support clinical operations project and study team members. This role will directly support clinical operations planning activities. Key Responsibilities include, but are not limited to: · Use internal and industry data sources, along with data analytics, to generate insights used for the planning of clinical trials · Utilisation of current and emerging data sources to identify risks and challenges to optimise clinical trial protocol design · Lead the site feasibility process in close partnership with the network of local country teams · Provide timely, high-quality deliverables (e.g. recruitment plans, feasibility country pre-selection and final selection recommendations, etc.) to clinical trial teams to support the clinical trial planning · Comprehensive tracking of assumptions used to generate deliverables · Contribute to the tracking and reporting of team KPIs and OKRs · Drive continuous improvement in Feasibility and Clinical Operations Planning processes · Identify and share lessons learned, best practices within the team setting · May support the assessment, piloting and embedding of new data analytics and data sources to ensure GSK continues to access best in class solutions. · May act as Subject Matter Expert for tools and systems · Maintain information on impact and successes Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: · Bachelor’s degree in relevant field · 3+ years relevant industry experience · Demonstrated leadership in a clinical development operations or study feasibility role at a CRO, pharmaceutical company or other relevant environment · Proven track record in problem solving · Excellent project management skills gained in a complex matrix organization · Results orientated with a drive to set and reach challenging goals with high standards for performance · Excellent influencing and negotiation skills · Excellent written and verbal communication skills · Ability to build strong relationships · Ability to analyse data from divergent sources and translate it into meaningful recommendations · Good understanding of the drug development process · Understanding of all relevant industry guidelines (ie; FDA, GCP and ICH guidelines) Preferred skills: · Knowledge of Agile methodology · Experience utilizing clinical trial recruitment modelling tools · Experience utilizing industry clinical trial related data sources (i.e., Citeline, DQS, TriNetX, etc) · Experience with data manipulation, visualization, or advanced analytics · High level of proficiency with Microsoft Office 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 employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada-recruitment@gsk.com. Please do not send resumes to this e-mail and instead apply through the online application process of this posting. 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. 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