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 www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

As a Study Management Associate II, 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 II works as a 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 a Study Project Manager and SMA Manager. The Study Management Associate II 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 II 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 II is expected to work as a clinical study 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 contribution to one or more global trials in a cross-functional environment for activities from inception through closure, including but not limited to:
Supporting the Study Project Manager and cross-functional team through stakeholder engagement and influence to drive deliverables and timelines, including meeting facilitation and timely documentation at the study and regional levels 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, 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
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 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 2 years of pharma/device or clinical research related experience, with a moderate level of core and technical competencies
Competent in application of standard quality procedures (SOP, ICH/GCP, Global Regulations)
Analytical and critical thinking skills to evaluate complex issues from multiple perspectives and contribute to strategy and 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.
Strong interpersonal skills with ability to communicate effectively in a clear and persuasive manner; proficient in business/technical English-language (oral and written)
Proactive, collaborative mindset
Ability to work independently in a fast-paced global team environment
Preferred: Experience with 1 or more clinical trial systems (e.g., EDC, IRT, CTMS, eTMF); experience in 1 or more parts of a clinical trial

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.

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