Are you ready to lead and inspire? As a Local Study Associate Director (LSAD), you will lead Local Study Teams (LSTs) at the country level to deliver clinical studies within agreed resources, budget, and timelines. You will ensure compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations. In addition to leading LSTs, you may 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
Overall responsibility for study commitments within the country and timely delivery of data to required quality.
Lead Local Study Team consisting of CRA(s), CSA(s) for assigned study/studies.
Optimize the performance of Local Study Team(s) ensuring compliance with AZ Procedural Documents, ICH-GCP, and local regulations.
Ensure high-quality clinical and operational feasibility assessments of potential studies.
Coordinate site selection by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits.
Ensure timely submission of application/documents to EC/IRB and Regulatory Authority.
Prepare and maintain accurate study budgets in AZ clinical studies financial system.
Prepare local Master CSA (including site budget) and amendments as needed.
Prepare country level Master Informed Consent Form (MICF) and subsequent site level ICFs.
Collect and verify trial essential documents prior to study start.
Plan and coordinate local drug activities.
Set up and maintain the study in CTMS at study country level.
Oversee monitoring activities from site activation through to study closure.
Review monitoring visit reports and advise monitors on study-related matters.
Perform co-monitoring, Accompanied Site Visits/training visits with study CRAs.
Identify risks and facilitate resolution of complex study problems.
Organize regular Local Study Team meetings.
Maintain good personal relationships with all Local Study Team members, sites staff, and global stakeholders.
Report study progress/update to the Global Study Associate Director/Global Study Team.
Contribute to patient recruitment strategy.
Develop and review risk management plan on country study level.
Communicate regularly with National Co-ordinating Investigator/National Lead Investigator on recruitment and other study matters.
Plan and lead National Investigator meetings. Assist in forecasting study timelines, resources, recruitment, budget, study materials, and drug supplies.
Ensure relevant systems are set-up, updated, and access is organized at country level.
Ensure accurate payments related to the study are performed according to local regulations and agreements.
Participate in training and coaching new members of the Local Study Team.
Ensure completeness of the eTMF and maintain it Inspection Ready.
Ensure all study documents are ready for final archiving and completion of local part of the eTMF.
Plan and lead activities associated with audits and regulatory inspections.
Provide input to process development and improvement.
Provide regular information to Line Managers at country level on study/ies and planned study milestones/key issues.
Update Line Managers about the performance of the CRAs/CSAs.
Ensure compliance with local policies and code of ethics.
Provide feedback on research-related information useful for the local market.
Collaborate with local Medical Affairs team.
Support SMM in different initiatives as agreed with SMM Line Management.
Requirements: Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields
This position is open to all candidates.
