Associate Director, Project Manager Country Operations

AstraZeneca • Boston, MA

8d • $142,171 - $213,257 • Hybrid

About The Position

The Associate Director, Project Manager Country Operations (AD PMCO) is responsible for the successful execution of study deliverables and the quality execution of high priority and/or complex protocol procedures within their assigned countries. This role ensures adherence to good clinical practices (GCP), evolving regulatory requirements, and internal working procedures, while managing agreed-upon resources and ensuring quality and consistency in timely completion of site management and monitoring activities.

The AD PMCO leads local study teams, ensuring rapid start-up activities, site identification, feasibility, qualification, regulatory submissions, site setup, monitoring, and closure. They drive adherence to timelines and milestones, identify and manage risks, and develop mitigation plans. The role also focuses on effective issue identification and problem-solving through monitoring activities, supporting CRAs in producing high-quality monitoring, and ensuring CRAs understand complex protocol processes. Additionally, the AD PMCO identifies resourcing needs and collaborates with stakeholders to ensure adequate study resourcing.

The AD PMCO ensures study design and timelines are achievable locally and meet performance expectations. In coordination with other stakeholders, they identify the need for oversight site visits or accompanied site visits. The role is accountable for delivering country-level recruitment by liaising with local affiliates and global functions to implement effective recruitment action plans.

Key responsibilities include ensuring the quality and timeliness of study deliverables such as site identification, feasibility, start-up, recruitment, data delivery, documentation filing, and site closures. This involves CDA delivery and negotiation, conducting country feasibility assessments, ensuring the site selection process, and managing timely submissions to regulatory authorities. The AD PMCO also collaborates on the negotiation of site contracts and budgets, ensures collection and verification of essential trial documents, drives compliance with site activation projections, and manages study setup in CTMS and local registries. Oversight and coordination of monitoring activities, meeting recruitment targets, proactive reporting of study issues, and functional reporting to management are also key aspects of the role. The AD PMCO supports the Head of Country Operations (HCO) in driving country strategy, identifying and leading actions for growth and process improvement, and managing relationships with national key opinion leaders and external stakeholders. There is a potential to mentor Senior Manager PMCO and Country Study Managers.

Requirements

• Strong leadership: including the ability to make decisions independently, ability to combine role of formal, informal leader, mentor and coach. Independently determines 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 timely risks 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.
• Bachelor's Degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences or drug development is required.
• 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.

Nice To Haves

• A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD) is preferred.
• Lead CRA/management experience preferred.
• 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.

Responsibilities

• 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).
• 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.
• 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.
• 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 the recruitment projections for the assigned studies.
• Proactive reporting of study-specific issues (including monitoring metrics) to the study team.
• 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 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.

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Manager