Overview

Description:

Position Summary: The Sr CTMA/SMA assists the SPM or OSL in the operational execution of assigned clinical studies. The Study Management Associate is responsible for supporting the planning and execution of one or more Phase 1-4 clinical research studies. The SMA performs clinical trial related responsibilities to ensure studies are executed with quality and efficiency, on-time, within budget, and in support of company objectives. Responsible for executing one or more elements of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures). Supports the Study Project Manager in leading the cross functional study team Supports the preparation of Clinical Study Team meetings (Agenda/Minutes) Responsible for regular updates to the cross-functional team and stakeholders on study status; ensure our CTMS is up to date Supports the development of the clinical study blueprint/protocol and associated systems and documents (Informed consent forms, eCRFs, IRT, CSR) Supports the vendor selection, scope development, management and oversight of external vendors in compliance with AbbVies processes and procedures and the applicable regulations. Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies Proactively identify and resolve and/or escalate study related issues Participates in process improvement initiatives In addition to the essential skills, the incumbent must have the following: * Ability to handle and prioritize multiple tasks simultaneously, * Work effectively in a team/matrix environment, * Understand technical, scientific and medical information, * Handle conflict management and resolution, and * Understand clinical study budgets * Plan, organize, project manage and analyze data, * Advanced computer skills in Microsoft Office Qualifications / Experience: * B.A/B.S. in science or health-related field * Four (4) years clinical research experience or related experience with a Bachelors Degree * Monitoring experience is preferred Additionally, they would need to understand clinical study budgets and be able to handle and prioritize multiple tasks simultaneously.

About Aerotek:

We know that a company’s success starts with its employees. We also know that an individual’s success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek’s people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek’s 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Tracking

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