Associate Director Project Manager Country Operations

Are you ready to lead and innovate in the realm of clinical operations? As an Associate Director Project Manager Country Operations (AD PMCO), you'll be at the forefront of ensuring the successful execution of study deliverables across your assigned countries. Your role will involve leading local study teams, driving rapid start-up activities, and ensuring quality and consistency in site management and monitoring activities. You'll be responsible for identifying potential sites, conducting feasibility assessments, and ensuring timely submissions to relevant authorities. Your leadership will be pivotal in managing risks, preparing mitigation plans, and supporting Clinical Research Associates (CRAs) in producing high-quality monitoring throughout the study lifecycle. 
Are you prepared to make a significant impact on study design and timelines while meeting performance expectations?

Accountabilities

• Quality and timeliness of study deliverables: site identification, feasibility, start-up, recruitment, data deliverables, filing of complete study documentation, and site closures for assigned studies.
• Conduct country feasibility assessments with high quality in collaboration with local affiliate functions and global stakeholders.
• Ensure site selection process is conducted by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits.
• Ensure timely submission of application/documents to evaluating authorities at start-up and for the duration of the study.
• Collaborate for the negotiation of site study contracts and budgets at country level.
• Ensure collection and verification of trial essential documents required by ICH-GCP prior to study start.
• Drive compliance with committed site activation projections for assigned studies.
• Set up and maintain the study in CTMS at study country level as required by local laws and regulations.
• Oversight, management, and coordination of monitoring activities from site activation through to study closure.
• Meet recruitment targets for assigned studies and drive the Country/site recruitment action plan.
• Proactively report study-specific issues to the study team.
• Functional reporting to HCO and LM including updates about local study team performance, regular information on study milestones/key risks, leading risk-based quality meetings, etc.
• Relationship management with national key opinion leaders and external stakeholders impacting Country rare disease strategy in clinical development.

Essential Skills/Experience

• 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 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 Rare Disease Trial, managing high priority / complex studies through phases 1 – 4 . Previous experience  Rare Oncology and/or Gene Therapy trial preferred.
• Previous oversight and regulatory inspection experience preferred.
• Excellent understanding of the end-to-end Clinical Study Process including monitoring.
• 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 and Italian

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions.  That’s why, on average, we work a minimum of 50% of our days each month from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are driven by a passion for innovation that transforms lives. Our commitment to rare diseases means that every day is an opportunity to make a difference for patients who need it most. With a rapidly expanding portfolio, we offer an environment where creativity thrives alongside collaboration. Our culture is rooted in integrity, inclusiveness, and dedication to supporting communities worldwide. Here, your career journey is about making a meaningful impact while growing alongside exceptional leaders.

Ready to take on this exciting challenge? Apply now to join our team!

Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.