Study Start Up Manager
hace 2 semanas
OverviewStudy Start Up Manager at AstraZeneca – based in Barcelona, Spain. Commitment: on‑site 3 days a week. Fluency in English required. Your role is to accelerate site activation, turning regulatory and operational requirements into a predictable, high‑quality path to site activation.AccountabilitiesObtain and maintain essential documentation in compliance with ICH‑GCP and AZ Procedural Documents.Assist in coordination and administration of clinical studies from start‑up through site activation.Actively participate in local Study Delivery Team meetings and work cross‑functionally with Contracts, Feasibility and Study Support Services in US SM&M.Activate study sites in compliance with AZ Procedural Documents.Share information (metrics) on study site progress towards activation within local Study Delivery Team and US SM&M leadership as required.Drive delivery of regulatory documents at the sites; proactively identify delays in start‑up activities and the risks to the activation plan.Primary reviewer of site level Informed Consent Forms.Update Veeva Clinical Vault (VCV) and other systems with data from centres as per required per SAT process.Ensure regulatory binders and study supplies are provided for study site start up and/or delivered as per SAT process and agreement with Local Study Delivery Team.Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and QA.Ensure compliance with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).Ensure completeness of the Study Master File for study start‑up documents and site activation and ensure essential documents are filed in the TMF enterprise system (Veeva).Ensure timely delivery of proper documents for support of study team submission to Regulatory Authorities.Ensure that all start‑up study documents are ready for final archiving and sign‑off completion of local part of the Trial Master File.Contribute to production of study start‑up documents, ensuring template and version compliance.Create and/or import clinical‑regulatory documents into the A New Global Electronic Library (ANGEL) according to the Global Document List (GDL) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents to support publishing in ANGEL.Set‑up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. Veeva, MS Teams, Box etc) and support others in the usage of these systems.Essential Skills & ExperienceBachelor’s degree in a relevant discipline.Experience of Study Management within a pharmaceutical or clinical background.Knowledge of relevant legislation and new developments in Clinical Development and Study Management.Desirable Skills & ExperienceAdvanced degree within the field.Professional certification.Understanding of multiple aspects within Study Management.About AstraZenecaAstraZeneca is driven by a vision to eliminate cancer as a cause of death. Our team is dedicated to pioneering new frontiers in Oncology, fusing cutting‑edge science with the latest technology to achieve breakthroughs. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non‑discrimination in employment and work authorization and employment eligibility verification requirements.#J-18808-Ljbffr
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Study Start Up Manager
hace 2 semanas
Barcelona, España AstraZeneca A tiempo completoOverviewEs posible que un gran número de candidatos se presenten a este puesto, así que asegúrese de enviar su CV y su solicitud lo antes posible.Study Start Up Manager at AstraZeneca – based in Barcelona, Spain. Commitment: on‑site 3 days a week. Fluency in English required. Your role is to accelerate site activation, turning regulatory and...
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Study Start Up Manager
hace 2 días
Barcelona, España AstraZeneca A tiempo completoOverview Study Start Up Manager at AstraZeneca – based in Barcelona, Spain. Commitment: on‑site 3 days a week. Fluency in English required. Your role is to accelerate site activation, turning regulatory and operational requirements into a predictable, high‑quality path to site activation. Accountabilities Obtain and maintain essential documentation in...
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Study Start Up Manager
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barcelona, España AstraZeneca A tiempo completoIntroduction to role This role is based in Barcelona, with an on-site commitment of three days a week. Fluency in English is required. Are you ready to accelerate site activation so patients can access groundbreaking cancer trials sooner? As a Study Start Up Manager, you will turn complex regulatory and operational requirements into a predictable,...
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Study Start Up Manager
hace 2 semanas
Barcelona, España AstraZeneca A tiempo completoIntroduction to roleThis role is based in Barcelona, with an on-site commitment of three days a week. Fluency in English is required.Are you ready to accelerate site activation so patients can access groundbreaking cancer trials sooner? As a Study Start Up Manager, you will turn complex regulatory and operational requirements into a predictable, high-quality...
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Study Start Up Manager
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