Local Study Associate Director

About AstraZenecaAstraZeneca is a global science-led patient-focused biopharmaceutical company that focuses on the discovery development and commercialization of prescription medicines for some of the worlds most serious diseases But were more than one of the worlds leading pharmaceutical companies To lead Local Study Team s LSTs at country level to deliver committed components of clinical studies according to agreed resources budget and timelines complying with AZ Procedural Documents international guidelines such as ICH-GCP as well as relevant local regulations In addition to leading LST s 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 LSADs s might have different internal titles based on the experience level LSAD Senior LSAD The experience level depends on the years of experience performance record level of independence in the role ability to take on additional tasks or tutor more junior colleagues The Director Country Head Senior Director Country Head may assign this internal title after confirmation with Senior Director Cluster Head Executive Director Regional Head Typical Accountabilities 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 timeline 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 AstraZenecas 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 Why AstraZenecaAt AstraZeneca were dedicated to being a Great Place to Work Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit Theres no better place to make a difference to medicine patients and society An inclusive culture that champions diversity and collaboration and always committed to lifelong learning growth and development Were on an exciting journey to pioneer the future of healthcare Date Posted 26-May-2025Closing Date 30-May-2025AstraZeneca embraces diversity and equality of opportunity We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills We believe that the more inclusive we are the better our work will be 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 recruitment as well as work authorization and employment eligibility verification requirements