Associate Director Project Manager Country Operations (Alexion)

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 such as the Site Management Lead (SML), People Manager, HCO, CDQ etc.  

The AD PMCO will remain accountable for the delivery of the recruitment at country level. The AD PMCO will liaise with local and global functions to find productive ways to keep the recruitment above and according local projections, such as Engagement Visits with sites, local Investigator Forums, and other initiatives with internal stakeholders as well as with sites.

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 other functions such as Medical. 

• 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.

• Collaborationforthe 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 exercise for 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 exercise of recruitment projections for the assigned studies.

• Proactive reporting of study-specific issues (including monitoring metrics) to the study team

• Functional reporting to HCO andLM 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 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.

• Support in local / global initiatives as agreed with line manager.

• Endorsement by HCO in study activities subject to discussion with HCO (e.g: selection of sites, country commitment for the delivery of the trial, etc)

• Relationship management with the national coordinating investigator as applicable and coordination of country level engagement activities.

• Scheduling and leading effective country calls with local study team and/or CRO, as applicable.

• Leading recruitment discussions with relevant stakeholders (e.g: Medical functions, Patient Advocacy, global study functions) for the assigned trials and countries.

You will need to have:

• Proven experience in  oversight and leading the delivery of operational aspects of all stages of the clinical trial process.

• Solid knowledge of clinical development processes, with previous project/site management experience.

• Ability to lead, troubleshoot and influence for quality and delivery.

• A track record of ensuring GCP compliance and successful risk management of complex clinical studies is expected.

• Proven experience in effectively communicating with site staff including KOLs and thought leaders.

• Comprehensive and current regulatory knowledge, including GCP.

• Experience conducting GCP or other training is a plus.

• Flexibility in schedule and willingness to travel (required travel may be as high as 20% during busy periods).

• Good organizational skills and ability to deal with competing priorities.

• Effective communication skills (written, verbal and presentation).

• Creative thinker, curious and unafraid to ask questions.

• Innovator, willing to initiate changes, introduce new ideas, and creatively problem solve.

• Good analytical skills and ability in handling crisis situations.

• Excellent attention to details.

• Proficient with MS Office Suite (Excel, Word and PowerPoint). 

• Excellent knowledge of spoken and written English.

• Good intercultural awareness.

We would prefer for you to have:

• Bachelor's Degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences or drug development is required.  A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD) is preferred.

• A mininum of 5 years of relevant experience gained with a CRO or pharmaceutical company working on internal delivery model, multinational clinical studies; Lead CRA/management experience preferred.

• Strong project management skills.

• Proven experience in managing high priority / complex studies through phases 1 – 4 and in rare medical conditions preferred.

• Previous oversight and regulatory inspection experience preferred.

• Excellent understanding of the end to end Clinical Study Process including monitoring.