Local Study Associate Director (12-month contract)

At AstraZeneca we pride ourselves on crafting a collaborative culture that champions knowledgesharing ambitious thinking and innovation ultimately providing employees with the opportunity to work across teams functions and even the globe.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people the planet and our business are interconnected which is why were taking ambitious action to tackle some of the biggest challenges of our time from climate change to access to healthcare and disease prevention.

Note this is a 12month contract.

Introduction to role

Are you ready to lead and inspire Local Study Teams (LSTs) at the country level As a Local Study Associate Director (LSAD) you will be at the forefront of delivering clinical studies ensuring they meet agreed resources budgets and timelines. You will ensure compliance with AZ Procedural Documents international guidelines such as ICHGCP and relevant local regulations. In addition to leading LSTs you may also perform site monitoring as needed to support the flexible capacity model. Your role will be crucial in identifying sites performing site qualifications setting up initiating monitoring closing and archiving documentation.

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 optimizes the performance of the Local Study Team(s) at country level ensuring compliance with AZ Procedural Documents ICHGCP 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 startup 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.
• 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 crucial documents required by ICHGCP 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 handles and coordinates supervising activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
• Reviews supervising visit reports (as required and following AZ SOPs) and proactively advises the monitor(s) on studyrelated matters.
• Performs any required comonitoring Accompanied Site Visits/training visits with study CRAs.
• Proactively identifies risks and facilitates resolution of sophisticated study problems and issues.
• Organizes regular Local Study Team meetings on an agendadriven basis.
• Actively works towards achieving good personal relationships with all Local Study Team members sites staff and global partners.
• 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 vital.
• Develops maintains and reviews risk management plan on country study level: proactively manages sites collaborators local and global vendors and customers to ensure risks are timely identified mitigated and managed.
• Communicates and coordinates regularly with National Coordinating 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 businesscritical licensetooperate activities (for example Safety Reporting Regulatory submissions Clinical Trial Transparency) are setup updated and access is organized 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 ICHGCP and AZ Procedural Documents.
• Ensures completeness of the eTMF and ensures crucial 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 researchrelated 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.

Essential Skills/Experience

• Bachelor degree in related discipline preferably in life science or equivalent
• Minimum 3 years of experience in Development Operations (CRA SrCRA) or other related fields (Medical Affairsled or Academicled studies).
• Good knowledge of international guidelines ICHGCP as well as relevant local regulations.
• Proven track record to lead and empower crossfunctional teams to deliver clinical trials according to or ahead of time plan budget and with required quality.

Desirable Skills/Experience

• Excellent project management skills.
• Excellent team building and interpersonal skills.
• Excellent organizational 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.
• Ability to travel nationally and internationally as required.
• Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.
• Good knowledge of the Drug Development Process.
• Excellent understanding of the Clinical Study Process including supervising.
• Very good understanding of the Study Drug Handling Process and the Data Management Process.
• Integrity and high ethical standards.
• Good analytical skills.
• Good resource leadership skills.
• Good decision making and delegation skills.
• Good financial leadership skills.
• Basic change leadership skills.
• Basic coaching skills.
• Basic ability in handling crisis situations.
• Good intercultural awareness.

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AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment assessment and selection process and may be requested by emailing.

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Date Posted