[Oncology]Local Study Associate Director

hace 2 semanas

España AstraZeneca GmbH A tiempo completo

AstraZeneca is expanding our therapeutic area into cell therapy, and therefore searching for potential leaders who can manage cell therapy clinical studies.LSAD is to lead Local Study Team(s) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.The Local Study Associate Director (LSAD) may perform site monitoring as needed to support the flexible capacity model.The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.(Typical Accountability)Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies.Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with AZ Procedural Documents, ICH-GCP and local regulations.Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head).Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant AZ SOPs and local regulations.Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with AZ SOPs.Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.Reviews monitoring visit reports (as required and following AZ SOPs) and pro-actively advices the monitor(s) on study related matters.Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.Proactively identifies risks and facilitates resolution of complex study problems and issues.Organises regular Local Study Team meetings on an agenda driven basis.Actively works towards achieving good personal relationships with all Local Study Team members, sites’ staff and global stakeholders.Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead.Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.Plans and leads National Investigator meetings, in line with local codes, as required.Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organised at country level.Ensures accurate payments related to the study are performed according to local regulations and agreements.Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and AZ Procedural Documents.Ensures completeness of the eTMF and ensures essential documents are uploaded in a timely manner to maintain the eTMF “Inspection Ready”.Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.Provides input to process development and improvement.Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.Updates Line Managers about the performance of the CRAs/CSAs.Ensures that study activities at country level comply with local policies and code of ethics.Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.Ensures compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).Collaborates with local Medical Affairs team.Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.(Functional Capabilities)Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.Excellent project management skills.Excellent team building and interpersonal skills.Excellent organisational skills.Excellent verbal and written communication skills.Excellent ability to prioritize and handle multiple tasks.Excellent attention to details.Excellent knowledge of spoken and written English.Good negotiation skills.Good ability to learn and to adapt to work with IT systems.Good medical knowledge and ability to learn relevant Therapeutic Areas.(Qualification)University degree in Pharmaceuticals, Biology, Medtech, biotechnologies, etc.Minimum 6 years of experience in clinical studies (prefer previous experience as project manager).Previous experience in cell therapy clinical studies (prefer previous experience as project manager).Fluent in English.
#J-18808-Ljbffr

  • Associate Director Insights

    hace 2 semanas

    España Regeneron Pharmaceuticals, Inc A tiempo completo

    The Associate Director Insights & Analytics (Oncology International) will provide strategic expertise to help optimize business performance and enable informed decision making. The role will report directly to the Director, Insights & Analytics (Oncology International). In addition, this role will oversee International Oncology performance analytics, as well...

  • Oncology Study Start-Up Associate Director

    hace 2 días

    España AstraZeneca GmbH A tiempo completo

    (Responsible for)Leading the ONC US Site Management and Monitoring Study Start-Up team to execute the delivery of site start-up activities for oncology studies.Developing and deploying cross-functional collaboration and coordination of the Study Start-Up Managers team resources to ensure optimal resource utilization and driving a best-in-class activation...

  • Global Study Associate Director Late Oncology

    hace 17 horas

    España AstraZeneca GmbH A tiempo completo

    Location: Barcelona, Spain (On-site). 3 days working from the office and 2 days working from home.The Global Study Associate Director (GSAD) is responsible for the delivery of clinical studies, including quality, timelines, budgets, resources, investigational sites, vendors, and key project deliverables in compliance with SOPs, Regulatory requirements and...

  • Associate Director Insights

    hace 2 semanas

    España Regeneron A tiempo completo

    The Associate Director Insights & Analytics (Oncology International) will provide strategic expertise to help optimize business performance and enable informed decision making. The role will report directly to the Director, Insights & Analytics (Oncology International). In addition, this role will oversee International Oncology performance analytics, as well...

  • Clinical Research Associate

    hace 5 meses

    España MRL Consulting Group A tiempo completo

    **Senior Clinical Research Associate** **About Us**: **MRL Consulting Group** is partnered with a leading contract research organization dedicated to advancing the field of oncology research. They are committed to conducting groundbreaking clinical trials that lead to the development of innovative cancer treatments. Our mission is to improve the lives of...

  • Associate Director of Translational Regulatory Science

    hace 2 semanas

    España AstraZeneca A tiempo completo

    Associate Director of Translational Regulatory ScienceWithin Oncology Regulatory Science, Strategy & Excellence (ORSSE), we bring hope and solutions to patients across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We...

  • Associate Director, Trial Clinical Delivery Lead

    hace 1 semana

    España EMD A tiempo completo

    Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich...

  • Associate Director, Trial Clinical Delivery Lead

    hace 2 semanas

    España Merck Group A tiempo completo

    Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich...

  • Medical Director- Oncology/Hematology

    hace 2 semanas

    España IQVIA A tiempo completo

    Job Overview The medical department consists of a Chief Medical Officer, Medical Directors, medical writers, and safety associates. The Medical Director provides medical and scientific support to clinical research programs, study teams, and investigators. The Medical Director also provides review, advice, and leadership for potentially or awarded clinical...

  • Study Start Up Associate

    hace 1 semana

    España ICON plc A tiempo completo

    Study Start Up Associate II - Spain, Madrid ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. Study Start Up Associate / Regulatory Submissions -...

  • Senior Study Start Up Associate

    hace 3 días

    España ICON A tiempo completo

    Senior Study Start Up AssociateICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.We are currently seeking a Senior Study Start Up Associate to join...

  • Senior Study Start Up Associate

    hace 2 días

    España ENGINEERINGUK A tiempo completo

    Senior Study Start Up AssociateICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.We are currently seeking a Senior Study Start Up Associate to join our...

  • Senior Study Start Up Associate

    hace 3 días

    España ICON Plc A tiempo completo

    ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.We are currently seeking a Senior Study Start Up Associate to join our diverse and dynamic team. As...

  • Study Director

    hace 2 semanas

    España Biobide A tiempo completo

    Position: Study Director Candidate profile: Ph.D. in life sciences with knowledge in toxicology and Zebrafish Main functions: Leading R&D projects, internal and clients’. Scientific posters and articles writing. Taking part at conferences and presenting posters. Objective and experiments designing. Collaborate with Zebrafish facility. Team coordination...

  • Medical Director

    hace 2 semanas

    España Precision Medicine Group, LLC. A tiempo completo

    Medical Director - Clinical Trial ServicesRemote HungaryJob Type: Regular Full-timeDivision: Precision for MedicineBusiness Unit: Clinical SolutionsRequisition Number: 4774Precision for Medicine is hiring a Medical Director to join our team, candidates can work remotely in any of the following locations: UK, Spain, Poland, Hungary, Romania, Serbia or...

  • Associate Director Scientist, Early Oncology Global Development

    hace 2 semanas

    España AstraZeneca A tiempo completo

    Location: Barcelona, Spain (3 days working from the office and 2 days working from home) The AD Scientist is an important member of the Project Team, working under the supervision of a clinical lead/study physician or senior clinical scientist, supporting activities related to the medical scientific aspects of the compound and its development. The...

  • Global Study Manager CVRM

    hace 2 semanas

    España AstraZeneca A tiempo completo

    Location: Barcelona, Spain (on-site) / 3 days working from the office and 2 days working from home The Global Study Manager is a member of the extended global study team supporting delivery of clinical studies within Bio Pharmaceuticals Clincal Operations, Study Management to time, cost and quality, from Clinical Study Protocol (CSP) development through...

  • Associate Director, Local Compliance Officer Spain

    hace 2 semanas

    España Teva A tiempo completo

    Associate Director, Local Compliance Officer SpainMinimum Qualifications:Typically > 10 years’ professional experience of which 5+ years of Compliance experience, preferably as Compliance officer in the pharmaceutical industry. Additional experience in other control functions such as legal, regulatory, audit or finance is welcome.University degree,...

  • Associate Epidemiology Director

    hace 2 semanas

    España IQVIA A tiempo completo

    Associate Epidemiology Director IQVIA Real World Solutions Home-Based / Hybrid / Office-Based Join us on our exciting journey! This innovative epidemiologist role sits in the Center for Advanced Evidence Generation (CAEG) at IQVIA and reports directly to the Chief Scientific Officer. CAEG works alongside scientific teams across IQVIA and is responsible for...

  • Associate Director, Local Compliance Officer Spain

    hace 2 semanas

    España Tevapharm A tiempo completo

    Associate Director, Local Compliance Officer SpainDate: Sep 4, 2024Location: Madrid, Spain, 28108Job Id: 58079At Teva we are all in for better health for our patients, our society, and our planet and for our people. TEVA is one of the pharmaceutical companies that treats the most patients in the world, 200 million every day, and its differential element is...