Associate, Study Management III

Summary

Join AbbVie as a Study Management Associate (SMA) and drive the end-to-end process for Investigator Initiated Studies (IIS), from intake to publication. You will play a key role in connecting functional areas within Medical Affairs and Health Impact, and across R&D. This role may also support the planning and execution of various Medical Affairs studies and external collaborations. Responsibilities include supporting the Study Project Manager in study execution, leading cross-functional teams, developing protocols and associated documents, managing vendors and supplies, conducting data monitoring, and liaising with investigators. The position requires a Bachelor's degree or equivalent, at least 4 years of pharmaceutical industry experience, and strong communication and analytical skills. This is a remote position.

Requirements

• Bachelor’s Degree or OUS equivalent required, degree in scientific field preferred; Associate’s Degree in Nursing with relevant experience also acceptable
• Must have at least 4 years of Pharmaceutical industry-related experience
• Demonstrated a high level of core and technical competencies
• Possesses good written and verbal communication skills
• Possesses analytical and critical thinking skills at operational and tactical levels

Responsibilities

• Support the Study Project Manager (SPM) in execution of study start-up, conduct and close-out of AbbVie Sponsored Research in compliance with quality standards (Global Regulations, AbbVie policies and procedures)
• Supports in leading the cross-functional study team: preparing team meeting agendas/minutes, regular updates to the cross-functional team (including affiliates, as necessary) and stakeholders on study status; ensuring the Clinical Trial Management System (CTMS) are complete and accurate; expected study documents are filed in the Trial Master File (TMF) in a timely manner
• Supports the development of the protocol
• Supports the development of associated systems (e.g., EDC and/or eCOA) and documents (e.g., Informed Consent Forms, Case Report Forms, Data Management Plan, Clinical Study Report, Publications, etc.)
• Supports vendor selection, defining scope of activities, and oversight all vendors in compliance with AbbVie’s process and procedures
• Supports the management of investigational product and other associated study supplies
• Supports generation of study related training for the study team members, study sites and selected vendors
• Remotely conducts routine monitoring of study data, identifying study-level issues and/or trends; recommends mitigations
• Support selection, activation, and maintenance of US sites
• Project manages externally sponsored research (e.g., investigator initiated studies and/or external collaborations) in compliance with quality standards (Global Regulations, AbbVie policies and procedures)
• Liaise with Sponsor Investigator or affiliates on operational aspects of the study (e.g., enrollment updates, milestone payments, supply of AbbVie product, protocol amendments, etc.)
• Responsible for MHI stakeholder management, raising risks and mitigations as appropriate
• Contributes to a team culture of information sharing, team building, and mentoring of junior staff
• Ensures inspection readiness and participate in related inspection/audit activities

Preferred Qualifications

Exposure to study initiation through study completion is preferred

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs