Serve as SDTL
•Responsible for planning and leading the delivery of all components of a clinical study to time, cost, and quality from Study Specifications (SS) through study closeout activities and Clinical Study Report (CSR).
•Form a motivated and aligned study team that delivers the study results on or ahead of time and to high quality
•Contributes in steering committees, submission assembly teams, regulatory defence teams, and contribute to Advisory Boards as necessary
•Prepare and deliver study level feasibility, and develop recruitment strategies, and the delivery of the approved Clinical Study Protocol
•Work with Line Managers to identify resource need and secure resources from various departments, timely form a motivated and aligned study team that delivers the study results on or ahead of time and to high quality
•Forecast and day-to-day management of study timelines, budget, materials and development of detailed study level plans and feasibility assessment
•Plan and lead activities associated with audits in liaison with CA+A; contribute to regulatory inspection strategy teams as required
•Participates in the negotiations and the selection process of external service providers•Develop &manage contingency risk plans to assure timely delivery to quality, budget,. and time and escalate issues to stakeholders as appropriate
•Lead preparation and delivery of study documents (e.g. Protocols/amendments, documents detailing study delivery data management activities, etc.), ensures operational inputs from other functions (e.g. Regulatory, Investigational Product Supply, etc.)
•Track and manage to agreed study time lines, budget, and resource and ensure the u date of appropriate systems (e.g. IMPACT, ACCORD)
•Plan, lead and ensure appropriate training is achieved at Investigator/monitor meetings
•Coordinate and/or contribute to timely delivery of Operations components of submissions to regulatory authorities (e.g. CSRs, annual reports)
•Ensure that study related decisions have taken into account for local study management requirements and constraints. Ensure active communication within LST and CPT throughout the entire study process by attending to meetings, video/tele conference whenever needed. Work with other members of the organization to share knowledge, experiences and best practices
•Drive best practices and provide development for staff within the projects; In liaison with Line Management, support competency development through mentoring, training, team support performance feedback
•Demonstrate willingness to take on any level project activity consistent with current or past experience in support of study delivery.
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 withClinical 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.
•For CRA work, see Monitor Job Description
