(Associate) Country Study Manager - RI

Serve as LSTL

• Overall responsibility for the study commitments within the country, for timely delivery of data to required quality as per SMA.
• Lead Local Study Team(s) consisting of monitors and study administrator(s).
• Lead and optimize the performance of the local Study Team(s) at country level ensuring compliance with AZ Procedural Documents, ICH-GCP and local regulations and to update other study team members on study matters
• Lead development of Local Monitoring Plan as per Targeted Monitoring guidance from respective Study Team.
• Contribute to review of monitoring visit reports and pro-actively advice the Monitor(s) on study related matters.
• Perform any required co-monitoring & QC visits with study monitor(s)
• Proactively identify and facilitate resolution of complex study problems and issues.
• Organize regular Local Study Team meetings on an agenda driven basis.
• Actively work towards achieving good personal relationships with all Local Study Team members.
• Report study progress/update to the SMO Study Leader/Team.
• Contribute to patient recruitment strategy including regular communication with concerned Investigators as necessary.
• Communicate and co-ordinate regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters.
• Coordinate the process for selection of potential Investigators considering capability, competence, etc, of the Hospitals/sites.
• Plan and lead national Investigator meetings, in line with local codes
• Assist in forecasting study timelines, resources, recruitment, budget, study materials and drugs.
• Work in close coordination with Study Drug Coordinator to create a robust Drug Consumption Plan.
• Ensure timely preparation of country SMA, fSMA and Master CSA.
• Ensure completeness of the Study Master File and ensure essential documents are sent to SMO/Hub location/site.
• Ensure local Serious Adverse Event (SAE) reconciliation takes place.
• Facilitate translation of documents (ICFs, patient diaries, participation cards, etc) through external providers.
• Ensure timely submission of proper application/documents to EC/IRB.
• Work together with Regulatory Affairs to ensure timely delivery of proper application/documents for submissions to Regulatory Authority.
• Set up and maintain the study in IMPACT at study country level.
• Ensure accurate payments related to the study are performed.
• Participate in training and coaching new members of the Local Study Team ensuring compliance with ICH/GCP and AZ Procedural Documents.
• Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Study Master File.
• Plan and lead activities associated with audits and regulatory inspections in liaison with Clinical Process Manager and QA.
• Provide input to process development and improvement.
• Provide regular information to Line Managers (SMM Director/CRM) at country level on study/ies and planned study milestones/key issues.
• Update Line Managers (SMM Director/CRM) about the performance of the monitors/CRAs.
• Ensure that study activities at country level comply with local policies & code of conduct.