Study Management Associate Iii

Abbvie Inc.; A distancia; MXN 1,093,000 - 1,458,000; Jornada completa

Descripción de la vacante

A leading global biopharmaceutical company is seeking a Study Management Associate III in Xico, Veracruz. The ideal candidate will have a Bachelor's degree and at least 4 years of experience in Pharma-related or clinical research. You will be responsible for managing global clinical trials, supporting cross-functional teams, and ensuring high-quality execution in alignment with strategic objectives. Exceptional analytical and organizational skills are required, along with proficiency in English. This role offers a chance to work in a collaborative global environment.

Formación

• At least 4 years of experience in Pharma-related or clinical research.
• Proficient in ICH/GCP and Global Regulations.
• Strong critical thinking skills to develop strategies.

Responsabilidades

• Support the Study Project Manager in leading the cross-functional team.
• Manage vendor relationships including RFP and deliverable oversight.
• Execute recruitment strategies and manage stakeholder meetings.

Conocimientos

Analytical skills

Organizational skills

Interpersonal skills

Proficiency in English

Educación

Bachelor's Degree

Herramientas

EDC

IRT

CTMS

eTMF

Descripción del empleo

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .

Job Description

Purpose

As a Study Management Associate III, you will be part of a dynamic, centralized study management team that is responsible for the execution of our global clinical trials and a key member of the study team.

The Study Management Associate III works as an independent, contributing member of a cross-functional and global partnership to plan, execute and manage one or more Phase 0-4 clinical trials under the guidance of the Study Project Manager and SMA Manager. The Study Management Associate III works to ensure that assigned studies are executed with quality and efficiency, in accordance with timelines and budget to support broader company strategic objectives. The Study Management Associate III is expected to work in accordance with all AbbVie Ways of Working.

This is a global role and may be located virtually.

Responsibilities

• Supports the Study Project Manager in strategic leadership of the cross-functional team through stakeholder engagement and influence to drive deliverables and timelines, including strategy development, meeting facilitation, and timely documentation at the study level to drive for timely execution of clinical trial(s)
• Vendor management, including Request for Proposal (RFP) / initiation, selection, Scope of Work development & review, deliverable oversight, and risk management for one or more external vendors, e.g., central lab, recruitment, imaging, internal and external committees
• Recruitment management, including thoughtful review of intelligence data, leadership, cross-functional development, and execution of recruitment strategies and mitigation planning on a global scale from country feasibility through subject recruitment and retention
• Leadership of assigned meetings (cross-functional (internal), vendor, and / or investigator) and provision of regular updates on study status, e.g., agenda development, minutes curation and filing
• Ensure inspection readiness and participate in related activities. Risk identification, mitigation, and management, including timely issue review, escalation, and management to support trend analysis and risk prevention.
• Co-development and management (review, revision, tracking and filing) of study materials, including but not limited to :
  • Protocols
  • Regulatory submissions
  • Patient reported outcome measures
  • Study execution plan
  • Informed consent
  • Site budgets and agreements
  • Clinical study report
  • Training materials
  • Newsletters
  • Presentations for various stakeholders
• Provide engaging training to identified stakeholders as needed, e.g., study team members, vendors.
• Support global submission strategies.
• Support process improvement initiatives or serve as a subject matter expert and / or mentor.

Additional Information

Bachelor's Degree.

Must have at least 4 years of progressive Pharma-related / clinical research-related experience with a high level of core and technical competencies.

Competent in application of standard quality procedures (SOP, ICH / GCP, Global Regulations).

Experienced user of systems such as EDC, IRT, CTMS, and eTMF.

Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives to actively develop strategies and drive smart decision making to support acceleration of study timelines and enable a well-run study.

Excellent organizational and time management skills, strong attention to detail.

Exceptional interpersonal skills with ability to communicate effectively in a clear and persuasive manner in a global setting; proficient in business / technical English-language (oral and written).

Proactive, collaborative mindset.

Ability to work independently in a fast‑paced global team environment.

Preferred

Exposure to study initiation through completion activities; global study exposure.

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.

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