Associate Director, Project Manager Country Operations

About this role

The AD Project Manager Country Operations (AD PMCO) is accountable within their   countr ies   for the successful execution of study   deliverables   and the quality execution of high priority and / or complex protocol procedures through adherence to good clinical practices (GCP), evolving regulatory requirements, ALXN/AZ working procedures with the agreed resources and ensuring quality and consistency in timely completion of   site management and   monitoring activities.  

The AD PMCO is accountable for   leading local study teams,   ensuring rapid   start up activities across assigned   studies , ensuring that sites are identified, feasibility is conducted, site qualifications performed, the study is submitted to the relevant authorities for evaluation, sites are set up, monitored, closed and final documentation   archived .   The AD PMCO will also drive adherence to timelines and milestones of study goals as well as   identifying ,   managing   and communicating risks to the study team and preparing mitigation plans.   

The AD PMCO will ensure that monitoring activities at study sites results in the effective identification and problem solving of issues. AD PMCO will support CRAs in producing high quality of monitoring throughout the cycle life of the study. For that purpose ,   the AD PMCO will ensure that CRAs assigned to the study understand complex protocol processes and procedures and may support CRA protocol-specific training. AD PMCO will also   identify   any resourcing issue and discuss with the relevant stakeholders ( i.e :   relevant people manager ) to ensure that assigned studies are appropriately resourced.   

The AD PMCO will be accountable for ensuring study design and timelines are achievable in the local environment and meeting performance expectations .    

The AD PMCO, in coordination with other stakeholders ( e.g : Quality Representative, Head of Country Operations,   People   Manager, etc), and as part of the exercise of   country risk assessment, will identify the need to conduct oversight site visits / accompanied site visits. Those might be conducted by the AD PMCO or other functions   accordingly with the ASV guidance   and under to accountability of HCO .    

The AD PMCO will remain accountable for the delivery of the recruitment at country level. The AD PMCO will   liase   with local   affiliate   and global functions to   implement the most effective Country and Site recruitment action plan to deliver the committed recruitment   with quality .  

You will   be responsible for :  

• Quality and timeliness of study deliverables: site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation and   sites   closures for assigned study( ies ). T his includes:   

• CDA delivery and negotiation (based on pre-approved parameters and regardless of executory party).  

• Conduct of country feasibility assessment of potential studies with the highest quality, in collaboration with   local affiliate functions and other global stakeholders .   

• Ensuring site selection process is conducted by   identifying   potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.  

• Ensuring   timely   submission of application/documents to evaluating authorities ( i.e : EC/IRB and Competent Authorities as applicable) at start up and for the duration of the study, in line with local regulations. This will include the coordination   and collaboration , with the start up positions (where available) of the preparation of the country level Master Informed Consent Form (MICF) and   subsequent   site level ICFs, as   required , including any relevant translation, in line with relevant SOPs. country/site level for the assigned studies.  

• Collaboration   for   the negotiation of site study contracts and budgets for the assigned studies at country level in coordination with other functions such as   start up   manager. The AD PMCO will ensure   timely   preparation of local Master CSA (including site budget) and amendments as applicable in the country.  

• Ensuring that 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   enroll , and in line with applicable SOPs.  

• Driving the   compliance with the committed   site activation projections for the assigned studies  

• Set up and maintenance of the study in CTMS   at study   country level as well as local registries and websites as required by local laws and regulations.  

• Oversight, management and coordination of monitoring activities from site activation through to study closure at country and site level   in accordance with   the Monitoring Plans.  

• Meeting recruitment targets for assigned study( ies ) and driving the   Country/site recruitment action plan   to deliver th e   recruitment projections for the assigned studies.  

• Proactive reporting of study-specific issues (including monitoring metrics) to the study tea m.  

• Functional reporting to HCO   and   LM   including:   

• Updates about the performance of   local   study team (CRAs, CSA, etc.)  

• Regular information at country level on study/ ies   and planned study milestones/key   risks and   issues.   

• Leading risk-based quality meetings, project performance reviews,   etc   for the assigned studies.   

• Regular information on any research related information including sites/investigators/competing studies that might be useful for the local market.  

• Report regular updates on assigned projects progresses, risks, action plans  

• Pro-actively   identify   potential risks at Country   level and   timely   escalate   and provide risk mitigation   plan   to HCO .  

• Supporting HCO to drive the Country strategy to achieve Country goals . Proactively   identify   and

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