Associate Director Project Manager Country Operations

at  Alexion PharmaceuticalsInc

ACCOUNTABILITIES:

As an AD PMCO, you will be responsible for the quality and timeliness of study deliverables, including site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation and sites closures for assigned study(ies). You will also be accountable for leading risk-based quality meetings, project performance reviews, and managing high priority / complex studies through phases 1 – 4.

ESSENTIAL SKILLS/EXPERIENCE:

• 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.
• 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).
• Bachelor’s Degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences or drug development.
• 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.
• Previous oversight and regulatory inspection experience preferred.
• Excellent understanding of the end to end Clinical Study Process including monitoring.

Join our dynamic team at Alexion, a division of AstraZeneca, as an Associate Director Project Manager Country Operations (AD PMCO). This role is pivotal in ensuring the successful execution of study deliverables and the quality execution of high priority and complex protocol procedures. You will be leading local study teams, ensuring rapid start-up activities across assigned studies, and driving adherence to timelines and milestones of study goals. This is a unique opportunity to make a significant impact on patient lives in a company where ‘Here it means more’ is more than a statement, it’s an ethos.