The Senior Project Manager Country Operations (SM PMCO) is responsible for the successful execution of study deliverables and the quality execution of high-priority and complex protocol procedures within their countries. This role ensures adherence to good clinical practices (GCP), evolving regulatory requirements, and ALXN/AZ working procedures. The SM PMCO leads local study teams, ensuring rapid start-up activities, site identification, feasibility assessments, site qualifications, and timely submission to relevant authorities. They drive adherence to timelines and milestones, manage risks, and prepare mitigation plans. The SM PMCO supports CRAs in producing high-quality monitoring throughout the study lifecycle and ensures studies are appropriately resourced. They also oversee recruitment at the country level and liaise with local and global functions to maintain recruitment projections.

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 other functions.
• 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 throughout the study.
• Collaborate on the negotiation of site study contracts and budgets at the country level.
• Ensure all trial essential documents required by ICH-GCP are collected and verified before setting sites ready to enroll.
• Drive site activation projections for assigned studies.
• Set up and maintain the study in CTMS at the country level as well as local registries and websites as required by local laws.
• Oversee, manage, and coordinate monitoring activities from site activation through to study closure.
• Meet recruitment targets for assigned studies and drive recruitment projections.
• Proactively report study-specific issues to the study team.
• Provide functional reporting to HCO and LM, including updates on local study team performance and regular information on study milestones/key issues.
• Lead risk-based quality meetings and project performance reviews for assigned studies.
• Manage relationships with national coordinating investigators and coordinate country-level engagement activities.
• Schedule and lead effective country calls with local study teams and/or CROs.
• Lead recruitment discussions with relevant stakeholders for assigned trials and countries.

Essential Skills/Experience

• Proven experience in 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 and Italian
• Good intercultural awareness.

Desirable 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 3 years of relevant experience gained with a CRO or pharmaceutical company working on multinational clinical studies; 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.
• Excellent understanding of the end-to-end Clinical Study Process including monitoring.

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 we work, on average, a minimum of three days per week 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's Alexion division, we champion diversity in a patient-driven culture where connections lead to new ideas that profoundly impact patients' lives. Our inclusive environment values different thinking so life-changing ideas can come from anywhere. We celebrate each other's successes while striving to meet the needs of underserved patients worldwide. With tailored development programs designed for skill enhancement and fostering empathy for patients' journeys, you'll be empowered to grow alongside our mission.

Ready to make a difference? Apply now!

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.