AbbVie

Associate, Study Management III

AbbVie • $88K — $105K *
North Chicago, IL 60064In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree or equivalent required
  • At least 4 years of experience in Pharma/clinical research
  • Understanding of quality procedures (SOP, ICH/GCP)
  • Proficient in EDC, IRT, CTMS, and eTMF systems
  • Strong analytical and critical thinking skills
  • Excellent organizational and time management skills
  • Exceptional interpersonal and communication skills in a global setting

Responsibilities

  • Lead and oversee multiple global clinical trials independently
  • Support the Study Project Manager in strategic leadership and stakeholder engagement
  • Manage vendors covering Proposal requests, Scope of Work, and deliverable oversight
  • Develop and execute recruitment strategies on a global scale
  • Manage study materials including protocols and regulatory submissions
  • Ensure compliance with CTMS and eTMF for inspection readiness
  • Provide training and support for stakeholders on study processes

Benefits

  • Paid time off including vacation, holidays, and sick leave
  • Medical, dental, and vision insurance
  • 401(k) plan eligibility
  • Participation in short-term incentive programs
Full Job Description
Job Description

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
  • The Study Management Associate III is expected to work independently as a clinical study leader and contributor with appropriate support from the Study Project Manager on the following activities in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures):
  • Study-level oversight and leadership of one or more global trials in a cross-functional environment for activities from inception through closure, connecting functional work and strategic work across the global study, including but not limited to:
  • o 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)
  • o 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
  • o 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
  • o 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. o 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:
    o 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
    o CTMS and eTMF management to ensure compliance/inspection readiness, support trend analyses and support timelines
  • o EDC, IRT, and ePRO, which includes review of design specifications, participation in user acceptance testing, and contribution to development and review of associated plans and key risk indicators, as well as system management activities like access support, query resolution, and oversight. Management of investigational product and other associated study supplies.
  • 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


Qualifications
  • Bachelor's Degree or OUS equivalent required
  • 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


Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), 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 to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

About AbbVie

AbbVie develops pharmaceuticals and medical devices. They provide products and services to therapeutic areas including immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology.

AbbVie Careers

Joining AbbVie means becoming part of a global team dedicated to making a remarkable impact on patients' lives. At AbbVie, our employees are united in the pursuit of groundbreaking innovation and are committed to transforming the future of healthcare with leading-edge science.

Work You’ll Do

At AbbVie, you’ll collaborate with some of the brightest minds in the industry to solve challenging problems that have a high impact on society. Our culture fosters growth and embraces leadership and diversity training, ensuring that every team member can thrive.

Explore Job Opportunities

AbbVie offers a wide range of job opportunities and career paths, providing a platform where professionals can propel their careers forward. From research and development to marketing and sales, the potential to make a significant impact is limitless.

Internship Programs

Kickstart your career with an AbbVie internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at AbbVie are considered integral members of the team and are given tasks that are both challenging and rewarding.

Professional Growth and Development

We believe in nurturing our team's professional growth through comprehensive training programs, leadership development opportunities, and continuous learning. Our commitment to your career growth is reflected in our robust offerings that enhance your skills and knowledge.

Benefits and Culture

AbbVie is dedicated to supporting our employees' well-being both inside and outside of work. Our benefits package includes health, financial, and social benefits that are designed to support the diverse needs of our employees. Our inclusive culture encourages collaboration and innovation, fostering a workplace where all can excel.

Hiring Process

Our hiring process is designed to ensure a match that will be beneficial both for the company and for your career aspirations. From resume submission to interview, each step is an opportunity to showcase your skills and fit with the AbbVie team.

Networking and Career Advancement

At AbbVie, networking doesn’t just enhance your career; it propels it. We encourage our employees to engage internally and externally to build relationships that foster personal and professional growth.

Join Our Team

Search open positions that match your skills and interests. We are looking for passionate, curious, and innovative team players who are ready to make a difference.

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Explore AbbVie Jobs

Whether you’re seeking to advance your career in a dynamic and empowering environment, or looking for a place where you can innovate, lead, and contribute to something bigger, AbbVie is the place for you. Join us in our mission to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
Learn more about AbbVie
Size
50,000 employees
Market Cap
$288.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ
ABBV
* Ladders Estimates

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