Margaret Pei Email & Phone Number

Parsippany, Nj

Trenton, Nj

Responsible for the development and maintenance of employment contact relationships and a database of available jobs, including: contacting companies and organizations to discover and develop new job leads; processing and posting job leads that come in; developing and maintaining database of employers; collaborating with the Publicity Committee to identify new opportunities for employment; reporting on issues to Executive Committee; identifying new members who have talents needed to support PSG; emailing members new job listings; following the overall business process of PSG and making recommendations to the Executive Committee when necessary

Bridgewater, Nj

Assisted Directors and Clinical Study Leads with conducting and maintaining multiple studies throughout study lifecycle; assisted Executive Director, Medical Affairs, with management of grants and investigator-initiated studies. Responsibilities included: contributing to successful gap analysis/mock inspection; managing trial master files on shared drives and web-enabled clinical-trial project management tools for inspection-readiness; overseeing essential document quality; registering and updating studies in ClinicalTrials.gov; archiving study documents; reviewing monitoring trip reports; participating in internal and external audits; study status tracking and reporting; reconciling study budgets and supplies; data reviews and reconciliations; managing grants from receipt to reconciliation; oversight of GRC meetings, agenda and minutes; managing investigator-initiated studies from inception to conclusion; tracking and reporting for US Healthcare Compliance; proofreading / editing protocols, amendments; creating and repairing templates and documents; providing training and technical support for colleagues

Managed trial master files on shared drives and web-enabled clinical trial project management tools; oversaw essential document quality; archived study documents; reviewed monitoring trip reports; participated in internal and external audits; study status tracking and reporting; reconciled study budgets and supplies; data reviews and reconciliations; registered studies in ClinicalTrials.gov

Cranford, Nj

Managed SOP life cycles; collaborated on and revised SOPs; tracked data and documents for efficient archival and retrieval; achieved proficiency with MCQS for process and document control; maintained and tracked training records; oversight of organizational charts; participated in internal and external audits; trained co-workers in usage of MCQS and software applications; trained co-workers in technical skills to alleviate ergonomic issues; created templates for tracking issues; repaired and restored templates and documents

Princeton, Nj

Selected clinical study sites and investigators; conducted feasibility surveys; created, distributed, collected, reviewed, tracked critical documents; issue-resolution of such with sponsors, study sites, investigators, IRBs and others; maintenance of sites throughout study life cycle; negotiated budgets and contracts; reviewed and revised ICFs for compliance with protocol and with ICH/GCP elements; obtained central and local IRB approvals; achieved regulatory “green light” for site activation and drug shipment; competent usage of electronic tracking systems and workspaces, including Trial Tracker, Lotus Notes and Documentum; collaborated with Safety to address inquiries regarding adverse events; quality review and translation of drug labels; prepared for and responded to internal and external audits; mentored junior colleagues