[Oncology]Local Study Associate Director
hace 1 mes
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
-
[Oncology]Local Study Associate Director
hace 1 mes
Barcelona, España Astrazeneca Gmbh A tiempo completoAstraZeneca 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,...
-
Global Study Associate Oncology
hace 7 meses
Barcelona, España AstraZeneca A tiempo completo**Location: Barcelona - On-Site** The GSA is a member of extended global study team supporting delivery of clinical studies within Late Development Oncology (LDO) to time, cost and quality, from Clinical Study Protocol (CSP)development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to study archiving. The GSA...
-
Global Study Associate Director Late Oncology
hace 7 días
Barcelona, España Astrazeneca A tiempo completo.Global Study Associate Director Late Oncology 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...
-
Oncology Study Start-Up Associate Director
hace 4 semanas
Barcelona, 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 6 días
Barcelona, España Astrazeneca A tiempo completo.Global Study Associate Director Late OncologyLocation: 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...
-
Oncologylocal Study Associate Director
hace 1 mes
Barcelona, 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,...
-
Global Study Associate
hace 5 meses
Barcelona, España AstraZeneca A tiempo completoAre you ready to join our Early Oncology Study Management Team at AstraZeneca and make a difference for patients living with cancer? At AstraZeneca, we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re passionate about the potential of science to...
-
Global Study Associate Director Late Oncology
hace 7 días
Barcelona, España Astrazeneca A tiempo completoGlobal Study Associate Director Late Oncology 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...
-
Global Study Associate Director Late Oncology
hace 1 semana
Barcelona, España AstraZeneca A tiempo completoGlobal Study Associate Director Late Oncology 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...
-
Associate Director, Experimental Oncology
hace 6 meses
Barcelona, España AstraZeneca A tiempo completoOncology is a core therapy area and growth platform at AstraZeneca and our vision is to deliver life-changing medicines that improve outcomes for patients most in need. Within Oncology Translational Medicine (TM), Experimental Oncology supports academic collaborations and external sponsored research that further our understanding of the mechanism of actions...
-
Associate Director
hace 6 meses
Barcelona, España AstraZeneca A tiempo completo**Job Title: Associate Director Study Data Manager"** **Career Level - E** **Introduction to role** Are you ready to take on a leadership role in Clinical Data Management (CDM)? We are seeking an Associate Director Project Data Manager to oversee the delivery of high-quality data for one or more assigned projects. This role requires an expert in CDM...
-
Oncology Study Start-Up Associate Director
hace 1 mes
Barcelona, 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 7 días
Barcelona, 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...
-
Global Study Associate Director Late Oncology
hace 7 días
Barcelona, 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...
-
Global Study Associate Haematology
hace 7 meses
Barcelona, España AstraZeneca A tiempo completo**Global Study Associate Haematology** **Location: Barcelona, Spain** When we put unexpected teams in the same room, we fuel ambitious thinking with the poweencouragespire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per...
-
Global Study Associate Director Late Oncology
hace 6 días
Barcelona, España Astrazeneca A tiempo completoGlobal Study Associate Director Late OncologyLocation: 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...
-
Global Study Associate Director Late Oncology
hace 1 semana
Barcelona, España Astrazeneca A tiempo completoGlobal Study Associate Director Late OncologyLocation: 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...
-
Global Study Manager
hace 6 meses
Barcelona, España AstraZeneca A tiempo completo**Location: Barcelona - On-Site** **Short role description** The GSM (Global Study Manager) is a member of extended global study team supporting delivery of clinical studies within Late Development Oncology (LDO) to time, cost and quality, from Clinical Study Protocol (CSP)development through study set-up, maintenance, close-out, development of Clinical...
-
Global Study Associate Director Late Oncology
hace 2 semanas
Barcelona, 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 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...
-
Oncology Study Start-Up Associate Director
hace 1 mes
Barcelona, 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...
