Associate Director, Project Manager, Country Operations (Boston, MA)

*Onsite position - located in Boston, MA.

This is what you will do:

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.

• Collaborationfor 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 planto deliver the 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 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 identifyand lead actions and projects to implement at Country level, aligned with Country goals and strategy defined by HCO, to support the growth and performance process improvement.

• Relationship management with the national key opinion leaders, involved in the relationship management with key Patient Advocacy Organization and other external stakeholders which can have impact on the Country rare disease strategy in clinical development.Accountable for the Country external scientific engagement plan for the assigned study and/or therapeutic area. Supporting other Country team member with the implementation of the activities associated to the external scientific engagement plan.

• Potential to act as mentor of Senior Manager PMCO and Country Study Manager.

You will need to have:

• Strong leadership: including the ability to make decisions independently, ability to combine role of formal, informal leader, mentor and coach. Independentlydetermines the goals for the local study team, prioritize them, implement the strategic line of development of the entrusted directions. Ability to lead, troubleshoot and influence quality and delivery.

• Strong communication skills: have strong social skills to build powerful and trustful relationships with internal and external stakeholders. To be recognized as a reliable source of support and guidance by the global study team, managers and colleagues. Good independent management of tense and difficult situations supporting the team to keep focus on the goals, objective and company values. Proven experience in effectively communicating with site staff including KOLs and thought leaders. Effective communication skills (written, verbal and presentation). Good intercultural awareness.

• Excellent organizational skills and planning: independently plan and manage projects of any complexity, including managing the budget of projects. Ability to work effectively cross-functionally. Independently and timelyrisks identification and development of mitigation and action plan. 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. A track record of ensuring GCP compliance and successful risk management of complex clinical studies is expected. Comprehensive and current regulatory knowledge, including GCP. Experience conducting GCP or other training is a plus. Good organizational skills and ability to deal with competing priorities.

• Champion of the company values.

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

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

• Excellent knowledge of spoken and written English.

We would prefer for you to have:

• Bachelor's Degree required 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 minimum 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.