Site Management Lead; Hybrid

Company Description

Abb Vie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

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

If designated as the study strategy leader, the role is a key member of the Clinical Study Team representing CSM globally from study planning to close out. If assigned to area site execution activities, the role directs site monitors in a matrix environment and serves as a liaison between site monitors, the study strategy leader, and the Clinical Study Team.

Accountable for driving study-level global and/or area-level CSM deliverables by targeted timelines with allocated resources for assigned studies.

Core Responsibilities:

• Study Level CSM Planning and Strategy:
  • Analyze study timelines and assumptions to confirm deliverables are feasible for CSM
  • 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
• Study Execution Accountability and Monitoring Oversight:
  • Ensure study-level and/or area-level timelines are maintained across the study lifecycle
  • Provide timely study information for country-level teams to execute milestones
  • Drive site-level activities at study and/or area level (site selection, activation, site engagement, protocol adherence, close out)
  • Oversee monitoring activities in collaboration with other SMLs to ensure quality deliverables 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
• RBQM (Risk-Based Quality Management):
  • Proactively identify, evaluate, and mitigate risks with action plans; contribute to the Risk Assessment and Mitigation Plan (RAMP)
  • Collaborate with other SMLs and stakeholders to manage risks and align with overall study execution
  • Ensure site compliance and analyze trends for continuous improvement
• Inspection Readiness and TMF (Trial Master File):
  • Provide inputs on expected CSM documents at the study level and drive TMF completeness for CSM artifacts
  • Oversee CSM Inspection Readiness activities from study start to close

This role requires onsite work at Abb Vie locations. The expected onsite days are Tuesday, Wednesday, and Thursday each week.

Locations:
Illinois (IL):
North Chicago;
Massachusetts (MA):
Worcester;
New Jersey (NJ):
Branchburg, Florham Park;
California (CA):
Irvine, South San Francisco

• Bachelor’s Degree or equivalent in a (para) medical or scientific field
• Minimum of 5 years of industry clinical research experience; preferred 2 years of monitoring or project management or equivalent on a global study
• Experience in study initiation through completion in multiple phases (Phase II/III; Phase I in patients); exposure to multiple therapeutic areas or disease states is highly desired
• Strong core and technical competencies in managing components of clinical trials
• Good communication and leadership abilities; able to influence in a matrix environment
• Competent in standard procedures (SOPs, ICH, Global Regulations, Ethics and Compliance)
• Strong written and verbal communication; fluent in English; excellent planning and…