Senior Site Management Lead

AbbVie; Taplow; On-site; GBP 90,000 - 120,000; Full time

Job summary

AbbVie seeks a Senior SML to provide direction and operational expertise for CSM integrity, quality and timeliness across assigned studies. The role leads study-level CSM strategy, coordinates site management activities, and ensures deliverables are completed on time with allocated resources.

Strong global clinical research experience and leadership are required. You will collaborate with cross-functional teams to address risks, ensure TMF completeness, and drive site engagement and protocol

Qualifications

• Bachelor's Degree or equivalent OUS degree, typically in (para)medical or scientific field.
• Industry clinical research experience including monitoring or project management on a global study.
• Global project management experience.
• Experience in multiple therapeutic areas or disease state/indications highly desired.
• Demonstrates leadership abilities and strong communication skills.

Responsibilities

• Provide direction and operational expertise for CSM integrity, quality, and timeliness of activities.
• Plan and drive study-level CSM strategic planning and deliverables with resources and timelines.
• Coordinate site management activities and ensure site-level deliverables are met.
• Identify, evaluate, and mitigate risks; contribute to RAMP and TMF completeness.
• Collaborate with Clinical Study Team to manage risks and ensure site compliance.

Job description

The Sr. SML provides direction and operational expertise for all Clinical Site Management (CSM) integrity, quality, and timeliness of activities in assigned studies. The position is assigned to studies as the overall CSM functional study strategy leader and single point of accountability for study level CSM deliverables from study planning to close out. Influences and aligns within Clinical Development Operations and other key stakeholders in assigned studies. Accountable for planning and driving study-level CSM strategic planning and completion of deliverables by targeted timelines and with allocated resources for their assigned studies. Directs and coordinates site management activities in collaboration with assigned SMLs managing area site execution activities if applicable. Accountable for driving overall study level CSM deliverables by targeted timelines with allocated resources for their assigned studies.,

Responsibilities

• 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 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 including site selection, activation, site engagement, protocol adherence and close out.
• Oversee monitoring activities at study level in collaboration with 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 assigned SMLs and stakeholders in the Clinical Study Team to address and manage risks to align with overall study execution.
• Ensure site compliance, elevate 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.
  Bachelor's Degree or equivalent OUS degree, typically in (para)medical or scientific field.
• Iindustry clinical research experience including monitoring or project management or equivalent experience on a global study. Global project management experience.
• 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 (Standard Operating Procedures, International Conference on Harmonization (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.
• Able to work well within a team and autonomously. Thinks positively.
• Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft OneNote
  AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.