Job Description

At AbbVie, we are committed to transforming scientific discoveries into creative medicines that improve the lives of patients worldwide.

We are seeking an experienced Site Management Lead (SML) to play a pivotal role in the delivery of global clinical trials. This is an opportunity to influence study strategy, lead site management activities across multiple countries, and partner with cross-functional teams to deliver high-quality research that advances our global pipeline As a SML, you will act as the primary Clinical Site Management representative within global study teams, providing leadership, operational expertise, and strategic oversight from study start-up through close-out.

KEY DUTIES AND RESPONSIBILITES

- Accountable for driving study level global and/or area level CSM deliverables by targeted timelines with allocated resources for their assigned studies.
- Analyze study timelines and overall study assumptions to confirm deliverables are feasible for CSM.
- Support and communicate CSM resource needs with Country Leaders in alignment with study deliverables and milestones.
- Accountable for study level site monitoring strategy, documented in Site Monitoring Plan.
- Accountable to set and lead Site Engagement Strategy.
- Ensure study-level and/or area-level timelines are maintained across the study lifecycle.
- Provide timely and essential study information for country-level teams to execute milestones.
- Drive site-level activities at study level and/or area level, including site selection, activation,



site engagement, protocol adherence and close out.
- Oversee monitoring activities at study and/or area level in collaboration with other assigned SMLs as applicable, ensuring quality deliverables, status tracking, and milestone adherence and acceleration if applicable.
- Drives CSM deliverables during data snapshots and database locks, aligned to Data Cleaning Plan.
- Ensure sites are closed per Site Closure Plan.
- Proactively identify, evaluate, and mitigate risks, ensuring effective action plans; key contributor to Risk Assessment and Mitigation Plan (RAMP)
- Collaborate with other assigned SMLs and stakeholders in the Clinical Study Team to address and manage risks to align with overall study execution.
- Ensure site compliance, escalate issues, and analyze trends for continuous improvement.
- Responsible for providing inputs on expected CSM documents at the study level and driving TMF completeness for CSM artifacts
- Responsible from study start to close for ensuring that on-going CSM Inspection Readiness activities are completed at the study level
- Report any adverse event within 24 hours as per AbbVie’s policies and procedures.
- Proactively participate in AbbVie’s WHS programs, adhere to policies and promote a safe work environment at all times.
- Adhere to AbbVie’s codes of conduct and compliance processes, including timely training and maintaining ethics and integrity.
- Other ad hoc duties such as administrative duties, as requested.

📌 Site Management Lead (Sydney)
🏢 Abbvie
📍 Sydney