Study Management Associate III

4 weeks ago

Shanghai, Shanghai, China AbbVie Full time

Job Description

Supporting the Study Project Manager

In this role, you will support the Study Project Manager in leading a cross-functional team through stakeholder engagement and influence to drive deliverables and timelines for global trials. This includes study-level oversight and leadership of assigned activities from inception through closure.

Vendor Management

You will be responsible for vendor management, from initiation through closure, including deliverable oversight and risk management. This will involve ensuring that vendors meet the required standards and timelines.

Recruitment Management

Recruitment management is another key aspect of this role. You will oversee recruitment from country feasibility through subject recruitment and retention.

Leadership and Communication

As a Study Management Associate III, you will lead assigned meetings and training, both internal and external. You will also provide regular updates on study status, including agendas and minutes.

Regulatory Compliance

Ensure that all studies are inspection-ready and participate in related activities. You will also identify, mitigate, and manage risks associated with study operations.

Study Materials and Systems

Co-develop and manage study materials and systems throughout the study life cycle, including protocols, informed consent, clinical study reports, and training materials.

Qualifications

To be successful in this role, you will have a Bachelor's Degree or equivalent. You must also have at least 4 years of progressive experience in pharma-related or clinical research, with a high level of core and technical competencies. Strong analytical and critical thinking skills are essential, as is experience with systems such as EDC, IRT, CTMS, and eTMF.

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