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- 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:o -Supports the preparation of Clinical Study Team meetings (Agenda/Minutes)o -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 AbbVie’s 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
- Bachelor’s Degree or equivalent required, typically in nursing or scientific field; Associate’s Degree, R.N. or equivalent with relevant experience is acceptable.
- May have at least 2 years Pharma-related/clinical research related experience or professional equivalent.
- Demonstrates analytical and critical thinking skills.
- Possesses good communication skills.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.
