Study Management Associate (SMA) II
Apply NowLocation:
North Chicago, IL, US
Company:
AbbVie is dedicated to discovering and delivering innovative medicines to address serious health issues and future medical challenges.
Summary:
The employee will manage contributions to global clinical trials and ensure compliance with quality standards. Candidates must have a Bachelor's degree and two years of relevant work experience.
Requirements:
Credentials: Bachelor's Degree
Experience: 2 years applying standard quality procedures to clinical trials, 2 years functioning independently in a matrixed environment, 2 years in clinical research work, 2 years using clinical trial systems or vendors, 2 years working with ICFs, protocols, and amendments
Job Description:
Key Responsibilities
- Contribute to global clinical trials from inception to closure, with support from the Study Project Manager (SPM) & in compliance with quality standards.
- Responsibilities include, but are not limited to:
- Drive deliverables & timelines;
- lead & manage meetings with stakeholders;
- Manage vendors, recruitment, CTMS & eTMF; Maintain Inspection Readiness;
- identify, mitigate & manage risks;
- Develop & manage study materials;
- provide training to stakeholders;
- Support EDC, IRT, & ePRO design specifications, user acceptance testing, plans & key risk indicators, & system management activities;
- manage IP & study supplies;
- Support process improvement initiatives & serve as a subject matter expert &/or mentor.
Education & Experience
Must have a Bachelor’s or foreign education equivalent, & 2 years of clinical research work experience. Of work experience required, must have 2 years in each of the following: (i) applying standard quality procedures to full clinical trials, including SOP, ICH/GCP, Global Regulations; (ii) working with ICFs, protocols, & amendments; (iii) functioning independently in a matrixed environment with teams in multiple time zones; (iv) using 1 or more of the following clinical trial systems or vendors: EDC, IRT, TMF, ePRO, CTMS, central labs, &/or central imaging; (v) analyzing & evaluating complex issues to accelerate study timelines & enable a well-run study; (vi) managing meetings (creating agendas, preparing minutes, or presenting); & (vii) ensuring data is clean, documents are accurate to maintain inspection readiness.
Work experience may be gained concurrently. 100% Telecommuting permitted.
