Site Management Lead

Compensation

• USD 109,500 - USD 208,500 yearly

Job Description

The Site Management Lead (SML) provides direction and operational expertise for all Clinical Site Management (CSM) integrity, quality, and timeliness of activities in assigned studies. The SML can serve as the overall CSM functional study strategy leader or manage area site execution activities in collaboration with other assigned SMLs, depending on the size, complexity, and geographic scope of the studies.

As a key member of the Clinical Study Team, the SML represents CSM globally from study planning to closeout, directing site monitors in a matrix environment and serving as a liaison between site monitors, the study strategy leader, and the Clinical Study Team.

Responsibilities

• Accountable for driving study level global and/or area level CSM deliverables by targeted timelines with allocated resources for 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 the 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.

  Drive CSM deliverables during data snapshots and database locks, aligned to the Data Cleaning Plan.

  Ensure sites are closed per the 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, escalated 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 ongoing CSM Inspection Readiness activities are completed at the study level.

Qualifications

• Bachelor’s Degree or equivalent OUS degree, typically in a (para)medical or scientific field.
• Minimum of 5 years in industry clinical research, including ≥2 years of monitoring or project management or equivalent experience on a global study.
• Preferred exposure in study initiation through completion across multiple phases (Phase II and III, Phase I in patients); experience across multiple therapeutic areas highly desired.
• Demonstrates a high level of core and technical competencies through management of various components of clinical trials.
• Strong communication skills and demonstrated leadership abilities; able to influence without authority in a matrix environment.
• Competent in applying standard business procedures (Standard Operating Procedures, ICH, Global Regulations, Ethics and Compliance).
• Excellent written and verbal communication skills, including fluency in English. Excellent planning and organizational skills and the ability to work effectively and efficiently in a dynamic, fast‑paced environment.
• Team player and self‑motivated; proactive thinker with strong presentation skills.
• Advanced proficiency in Microsoft Word, PowerPoint, Excel, and OneNote.

Equal Opportunity Employer

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving its community. Equal Opportunity Employer / Veterans / Disabled.

US & Puerto Rico applicants seeking a reasonable accommodation: learn more.