Associate, Study Management III (Remote)

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 :
• 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

CTMS and eTMF management to ensure compliance / inspection readiness support trend analyses and support timelines

Qualifications :

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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more :

Work :

Yes

Employment Type : Full-time

Key Skills

Portfolio Management,Wealth Management,Financial Services,Hybris,Microsoft Word,Banking,Cash Management,Data Management,Microsoft Powerpoint,Securities Law,Microsoft Excel,Internet Of Things

Experience : years

Vacancy : 1