Associate Director, Project Manager Country Operations

The AD Project Manager Country Operations (AD PMCO) is accountable within their countries 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). This 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 Mon