SUMMARY:

• Over 15 years of experience in the Pharmaceutical Industry and Clinical Research, in various project management roles to support Clinical Trials, Logistic /Supply Chain, and various Database Implementation Projects, as well as Administrative Support Roles and Account Management.
• Skilled in administration, business operations, clinical, communications, computer and information systems, technically skilled, with a strong clinical / medical terminology background, organized, critical thinking, ability to learn quickly.
• Possess excellent communication skills, conveying complex information, with tact, and professionalism.
• Effective and collaborative Team player, goal oriented, intuitive, and helpful in Customer Service related matters.
• Possess strong leadership skills, mentoring, analytical, and persistent work ethic abilities.
• Experience in working with legal and regulatory departments in contract negotiations, general service agreements, and consultancy agreements
• Experience in Information Technology, with In - depth troubleshooting, script / technical writing skills, and training, mentorship of end users, and support of customer service resolution, in preparation for execution of project completion.
• Able to demonstrate well developed and proven organizational, problem solving, analytical, customer service and oral and written communication skills.

TECHNICAL SKILLS:

• Microsoft Office/XP Applications: Excel, Word, Access, Powerpoint, Outlook, Microsoft Project
• SAP System Applications and Products
• OnCore (Forte) Clinical Trial Management Database - Yale Cancer Center
• Clinical Trial Management System Pfizer, Bayer
• EPIC (Yale)
• CSDS for Pfizer
• SSMS Drug Shipment Tracking System
• Visiontracker Clinical Trial Management Database
• MD Link Yale Cancer Center
• COEUS Yale Cancer Center
• IMPACT International Management Package for
• Clinicopia Drug and API Shipments and Inventory Management System
• Right Track 2 Clinical Trial Management System
• IMPALA IVRS Database
• tcVisualize Forecasting and Visual Simulation Desktop Tool
• GDMS Confidential the Administration of Clinical Trials
• Business Objects
• SciQuest (Yale)
• EMS (Yale)
• RAVE (EDC) Medidata (Course Certification in processs)
• NIH Database
• CT.GOV

PROFESSIONAL EXPERIENCE:

Confidential, Groton, CT

Confidential Compliance LEAD ANALYST

Responsibilities:

• Quality Qualifying Issue Management - Forming Confidential Team
• Determine Significance of Confidential with team, follow up as needed
• Tracking of Documentation meeting outcomes in meeting minutes
• Facilitating root cause analysis and producing outputs
• Ensuring all documentation is entered and tracking in two databases
• Project management of clinical trial issues at involved sites

Confidential, New Haven, CT

SENIOR Administrative Assistant

Responsibilities:

• Project Management of ENT/Otolaryngology Department move for the Head and Neck Program for
• Manage activity in small 8 person office, point person for all incoming visitors, issues, problems, and primary point person in Support of Professor and Chief.
• Facilitation of all SOPS for Onboarding Physicians into the Department, Management of the Chief’s Calendar, and all functions relating to support of the chief.
• Assisting in overage work from Clinical Admins with Confidential 9 Coding
• Spearheading Department Moral Building Meetings, with Office Manager.
• Organized Office relocation for 5 employees with related internal Confidential vendors.
• Managed Expenses for all Lab Personnel, and Chief, and one other Faculty doctor.
• Self taught all Confidential systems - self starter.
• Credentialing for the Chief - for Greenwich and Bridgeport Hospitals, and VA Hospital.

Confidential, New Haven, CT

REGULATORY AFFAIRS ASSISTANT

Responsibilities:

• Coordination and set up of monitor visits, and study close-outs. Identify and communication with investigators, and study staff, preparation of regulatory submissions to in - house Confidential and Confidential studies, and coordination of site initiation visits with all study related staff.
• Regulatory compliance of all Confidential Cancer Center Clinical Trial protocol amendments as follows: prepare amendments for submission to the Confidential, (Internal Review Board), update the Confidential Cancer Center protocol database with protocol submission and approval s. Processing of protocol status changes, such as study closure notices as follows: prepare and submit protocol status changes to the Confidential, update the protocol database with
• Submission and approval information, update the regulatory binder for Confidential Cancer Center studies, communicate with the appropriate staff regarding protocol status changes.
• Maintain the Confidential Cancer Center clinical research files ( Confidential approvals, amendments, serious adverse event reports, annual reviews
• Perform as a liaison for communication regarding regulatory compliance matters between Confidential Cancer Center and the pharmaceutical companies, when appropriate.
• Training new staff, in Regulatory compliance and standards
• EPIC-Super user

Confidential, CT

LOGISTICS COORDINATOR

Responsibilities:

• Completion of End of Study Reports for Shanghai Publishing Submissions, drug lot genealogy reports and investigator/site verification and processing.
• Extensive cGMP training within Confidential Systems, Standard Operating Procedures, in accordance with Confidential Global Quality and Safety Standards.
• Clinical Drug Shipment Management using various systems within Pfizer.
• Supports IVRS process related to inventory management and monitoring at depots and sites as appropriate, pending depot optimization strategy communication.
• Responsible for effecting site-to-site transfer and/or transfer of drug from Confidential site to depot/vendors, (ALMAC)
• Interfaces with the package coordinator and the label group
• Training for Drug Forecasting using Confidential Software
• Responsible for ensuring database information is updated to support relevant clinical supply activities, supporting drug accountability, and temperature logs.