Site Management Lead - (Clinical Research)

AbbVie; Madrid; Presencial; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

AbbVie seeks an experienced Senior/Global Site Management leader to direct CSM integrity, quality, and timeliness across assigned studies. You will shape the study-level CSM strategy and collaborate with global and country teams to drive site activation, engagement, and close-out, ensuring regulatory readiness.

You will manage resources, monitor risk, and maintain TMF artifacts, with a focus on cross-functional leadership in a matrix environment and fluency in English to communicate with global

Formación

• Bachelor’s Degree in a (para)medical or scientific field.
• Minimum 5 years of industry clinical research experience and preferred 2 years in monitoring or project management on a global study.
• Experience across multiple therapeutic areas and strong leadership abilities.
• Excellent written and verbal English communication skills.
• Ability to influence in a matrix environment and manage study timelines.

Responsabilidades

• Lead study-level CSM strategy and timelines to ensure feasibility and on-time delivery.
• Communicate CSM resource needs with Country Leaders aligned to milestones.
• Accountable for study-level site monitoring strategy and Site Engagement Strategy.
• Drive site activation, engagement, protocol adherence and close-out activities.
• Oversee monitoring activities with other SMLs; track quality and milestones.
• Contribute to Risk Assessment and Mitigation Plan (RAMP) and TMF completeness for CSM artifacts.

Conocimientos

Project management

Leadership

Communication

Risk assessment

Stakeholder management

Fluent English

Matrix environment

Educación

Bachelor's degree

Herramientas

Microsoft Word

Microsoft PowerPoint

Microsoft Excel

Microsoft OneNote

Descripción del empleo

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 atwww.abbvie.co.uk.Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

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, visithttps://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

What AbbVie Has to Offer

Our work can and does have a tangible, lasting impact on millions of people. But it's not just the results that matter. How we achieve them matters, too. Leading with purpose, we work to build a more sustainable future for generations to come. We do that by putting our expertise, resources and talent to work to make a real difference for patients, communities and our world.