Site Management Lead - (Clinical Research)

AbbVie; Maidenhead; On-site; GBP 70,000 - 110,000; Full time

Job summary

AbbVie in Maidenhead seeks an experienced Senior Manager to lead Clinical Site Management strategy and ensure timely, high-quality CSM deliverables across studies. The role can drive study-level site monitoring and collaborate with global SMLs and country teams to align timelines and resources.

You will develop and own the Site Monitoring Plan, Site Engagement Strategy, and TMF artifacts, guiding study execution from initiation to close out while managing risks with RAMP.

Qualifications

• Bachelor’s Degree or equivalent OUS degree in (para)medical or scientific field
• 5+ years of industry clinical research experience and preferred 2 years of monitoring or project management on a global study
• Fluency in English with excellent written and verbal communication skills
• Competent in SOPs, ICH, Global Regulations, Ethics and Compliance

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
• Lead Site Engagement Strategy and ensure timely milestones across study lifecycle
• Drive site-level activities including site selection, activation, engagement, protocol adherence and close out
• Oversee monitoring activities at study/area level with other SMLs to ensure quality and milestone adherence
• Identify and mitigate risks with RAMP and collaborate with Clinical Study Team to address issues
• Ensure TMF completeness for CSM artifacts and inspection readiness

Skills

Presentation skills

English proficiency

Communication skills

Education

Bachelor’s Degree or equivalent

Tools

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Microsoft OneNote

Job description

About AbbVie

AbbVie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Company Description

About AbbVie
AbbVie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The SML reports into the Associate Director/Sr. Manager, Global Site Management and 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.

Influences and aligns within Clinical Development Operations, with other assigned Site Management leaders, and key stakeholders in assigned studies. Accountable for driving study level global and/or area 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-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, 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.

Qualifications

• Bachelor’s 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 (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.


• 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 OneNote

Additional Information

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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html