ESR Programs Lead — External Research Operations

AstraZeneca GmbH; Gaithersburg (MD); On-site; USD 112,000 - 168,000; Full time

Job summary

AstraZeneca GmbH in Gaithersburg, MD seeks an ESR Manager to oversee externally sponsored research in the US. The role partners with franchise teams to lead start-up and execution, ensuring contracts, budgets, and data accuracy across ESR platforms to stay on time and inspection-ready.

The position emphasizes cross-functional collaboration, risk mitigation, and governance across AZ contracting, US franchises, and finance departments.

Qualifications

• Bachelor’s degree in a scientific or healthcare field or significant and comparable experience.
• 1–2+ years in pharmaceutical industry, ideally clinical study management or Externally Sponsored Research.
• Experience in study management systems.
• Familiarity with clinical study processes and guidelines (GCP/ICH for USA).
• Financial knowledge on study management.

Responsibilities

• Act as the primary local operational contact for external sponsor sites and internal stakeholders.
• Provide guidance on ESR operational processes to stakeholders.
• Ensure compliance with global and local policies and timely project delivery.
• Maintain study information in ESR systems and ensure documentation is complete.
• Coordinate local LSA governance meetings and document outcomes.
• Prepare research CDAs/CSAs timely.
• Monitor study performance and escalate when off track.
• Maintain study budgets in ESR system and ensure timely payments.
• Keep portfolio data updated in ESR systems quarterly.

Skills

Stakeholder management

Project coordination

Communication

Attention to detail

Education

Bachelor’s degree in scientific/healthcare field

Tools

ESR management systems

VCV system

ACCORD (budget/payments)

Job description

AstraZeneca GmbH in Gaithersburg, MD seeks an ESR Manager to oversee externally sponsored research in the US. The role partners with franchise teams to lead start-up and execution, ensuring contracts, budgets, and data accuracy across ESR platforms to stay on time and inspection-ready.

The position emphasizes cross-functional collaboration, risk mitigation, and governance across AZ contracting, US franchises, and finance departments.