Medical Research Support Associate - Immunology + Specialty

Serves as a Therapeutic Area primary point of contact for externally sponsored and affiliate-run research operations in global Medical affairs. Acts as the Subject Matter Expert for the review, approval, startup, maintenance and closeout procedures related of IIS proposals and Affiliate sponsored studies (i.e.PMOS).
Responsible for the overall tracking and maintenance of the proposal workflow management system and CTMS Databases reporting of study information and metrics. Identifies and escalates performance issues on studies to management and provide recommendations for resolution.

Key Responsibilities Include:

• Responsible for executing all elements of externally sponsored research in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures) (e.g., drug supply management, ICBs, reviews and approves HCP invoices/ payments against executed contracts) with minimal oversight and guidance.
• Responsible for management of clinical essential documents and critical regulatory documents for assigned projects/studies to ensure document packets for study start-up are complete and accurate and consistent with the study start-up timeline.
• Routinely interact with Evidence Leads on assigned projects and in meetings.
• Supports the preparation of Scientific Review Meetings (Agenda/ Meeting Materials).
• Supports on audit/ inspection activities for GCP requirements.
• Responsible for regular updates appropriate for cross-functional team and stakeholders on study status; ensure our CTMS is up to date.
• Participates in process improvement initiatives.

• At least 4-6 years pharma related research experience
• Bachelor's degree
• Knowledge of externally sponsored research (IIS, external research collaborations)
• Knowledge of clincical study execution
• Knowledge of Good Clinical Practices and ICH/Guidelilnes, and/or other Global Regulations
• Excellent organizational skills, attention to detail, and strong oral and written communications skill s