Global Clinical Study Delivery Lead - Multiple Positions Available (BB-45B54)

Found in: Talent UK

La version française est ci-dessous (French version is below)Please Note: Due to current COVID environment and virtual ways of working, we are open to talent across Canada working virtually from home during this opportunity. Strong preference however is for this person to be located in Mississauga/Ontario.Would you like to be part of GSK’s clinical development team, with an opportunity to drive and lead scientific innovation to deliver the next generation of transformational medicines for patients in areas of high unmet need? If so, this could be an excellent opportunity to explore. We have openings across a wide variety of therapy areas.JOB PURPOSE: As a Study Delivery Lead in Global Clinical Sciences and Delivery (GCSD) you will be responsible for leading the planning, implementation and reporting of clinical studies to time, quality, budget, company standards, scientific, ethical and regulatory requirements.Your responsibilities will include, but are not limited to:Accountable for coordination of a fully feasible Study Protocol, Informed Consent Forms, Study Procedures Manuals and Clinical Study Reports.Accountable for the study delivery strategy (e.g. country selection, recruitment of diverse study participants, patient engagement strategy, recruitment plan)Drive assessment, selection, engagement, and management of appropriate vendors.Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies.Make decisions which balance risk/benefit with clear understanding of impact on the study and project; acts to mitigate risk where appropriate.Work with matrix partners, asset lead and/or manager to develop and manage study level budget within project budget allocation.Actively partner to build relationships and collaborate with staff in other global functions.Encourage others within matrix and line teams to seek alternative perspectives and develop solutions.Why you?BASIC QUALIFICATIONS:Bachelor’s degree in life sciences or neuroscience3 to 6 years’ experience within the pharmaceutical industry or CRO environment in clinical operationsExperience of leading study teamsExperience in study management, global regulatory guidelines and ICH/GCPExperience in developing and writing study protocols, study procedures manuals, informed consent forms and clinical study reports.Experience working with investigators, external experts, Contract Research Organizations and vendorsExcellent influencing and negotiation skillsPREFERRED QUALIFICATIONS: Advanced degree in life science or related field (e.g. MS, PhD, PharmD)Highly developed communication skills appropriate to the target audience (including senior leaders), promoting effective decision-making where necessary

calendar_today3 days ago


location_on Stevenage, United Kingdom

work GSK

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