Senior Associate Director, Country Clinical Operations PM

AstraZeneca plc; Wilmington (DE); Hybrid; USD 142,000 - 213,000; Full time

Job summary

AstraZeneca seeks a seasoned clinical operations professional to manage country-level delivery for multiple studies. The role combines leadership with hands-on oversight of feasibility, regulatory submissions, site activation, and recruitment to ensure quality and compliant delivery across sites.

The successful candidate will coordinate contracts, budgets, and MICF/ICFs, while maintaining CTMS setup and monitoring activities.

Qualifications

• 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.

Responsibilities

• Quality and timeliness of study deliverables across sites including feasibility, startup, recruitment and data deliverables.
• Conduct country feasibility assessments with local and global stakeholders.
• Ensure site selection through identifying potential sites/investigators and Site Qualification Visits.
• Coordinate submissions to authorities (EC/IRB, competent authorities) and prepare MICF/ICFs as needed.
• Negotiate site study contracts and budgets at country level; prepare local CSA amendments.
• Set up and maintain study in CTMS and local registries in line with regulations.
• Oversee monitoring activities from site activation to study closure; ensure adherence to monitoring plans.
• Meet recruitment targets and implement country/site recruitment plans.
• Provide proactive updates on study progress, risks, and actions to the study team and HCO.
• Engage with key opinion leaders and external stakeholders; support external scientific engagement plans.

Skills

Leadership

Communication

Organization & Planning

Flexibility & Travel

MS Office

English proficiency

Education

Bachelor's Degree or equivalent in clinical practice/health care, life sciences or drug development

Clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD) preferred

Tools

CTMS

Job description

AstraZeneca seeks a seasoned clinical operations professional to manage country-level delivery for multiple studies. The role combines leadership with hands-on oversight of feasibility, regulatory submissions, site activation, and recruitment to ensure quality and compliant delivery across sites.

The successful candidate will coordinate contracts, budgets, and MICF/ICFs, while maintaining CTMS setup and monitoring activities.