Site Management Lead; Hybrid

Overview

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 several 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 can be assigned to serve as the overall CSM functional study strategy leader and/or can be assigned to manage area site execution activities in collaboration with other assigned SMLs dependent on size, complexity, and geographic scope of assigned studies.

Core Responsibilities

• Study Level CSM Planning and Strategy:
  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.
• Study Execution Accountability and Monitoring Oversight:
  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.
• RBQM:
  Proactively identify, evaluate, and mitigate risks, ensuring effective action plans; key contributor to Risk Assessment and Mitigation Plan (RAMP).
• Collaborate with other 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.
• Inspection Readiness and Trial Master File Management (TMF):
  Provide inputs on expected CSM documents at the study level and drive TMF completeness for CSM artifacts; responsible from study start to close for ensuring ongoing CSM Inspection Readiness activities are completed at the study level.

Onsite Requirement

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.

• Bachelors Degree or equivalent OUS degree, typically in (para) medical or scientific field.
• A minimum of 5 years of industry clinical research experience and preferred 2 years of monitoring or project management or equivalent experience on a global study.
• Preferred exposure in study initiation through study completion in multiple phases of studies (Phase II and III, Phase I in patients). Experience in multiple therapeutic areas or disease state/indications highly desired.
• Demonstrates a high level of core and technical competencies through management of various components of clinical trials.
• Possesses good communication skills and demonstrated leadership abilities. Able to influence without authority in a matrix environment.
• Competent in application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance).
• Demonstrated good 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.
• Strong ability to create and deliver presentations.
• Able to work well within a matrix team and autonomously. Thinks proactively.
• Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft One Note.

• This position includes pay disclosure requirements; compensation range describes base pay and may vary by geographic location. Individual compensation paid within this range depends on many factors and may be modified in the future.
• We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note:

No amount of pay is considered wages or compensation until earned, vested, and determinable. The amount and…