Administrative Assistant Project Manager
Resume:
Gwen Spangenberg
Horsham PA *9044
Cell Phone: 267-***-****
Email: ************@*****.***
CAREER PROFILE
Distinguished twenty year Pharmaceutical career consisting of leading, planning, budgeting, CRO studies and operations. Expert in team building, leadership, communications, organizational development and quality performance improvement.
PROFESSIONAL EXPERIENCE
United BioSource Corporation October 2014 - Present
Senior Clinical Trial Specialist
●Mentor, train, and develop less experienced staff members.
●Assist operations managers with special projects.
●Coordinate department staff determined by workload.
●Work closely with Sponsors and project Managers to ensure regulatory compliance for assigned projects.
●Prepare/review regulatory document packets to be sent to investigators regarding study participation.
●Create and maintain Regulatory Document Tracking Log for each investigator. Track receipt of regulatory documents using UBC Track as required.
●Conduct ongoing review of regulatory document to ensure compliance with FDA regulations, ICH/GCP guidelines, Standard Operating Procedures, and sponsor specific requirements.
●Review required approved regulatory documents prior to release of study drug or for initial submission to an institutional Review Board/ Ethical Committee.
●Maintain Investigator Master File throughout study.
●Track and maintain monitor reports. Copy files for closeout visits as needed.
●Provide assistance for sites with advertising and informed consent from approval process.
●Support UBC Project Manager with additional projects as requested.
●Attend study team meetings/teleconferences as needed.
●Attend Investigator meetings and provide technical support as needed.
●Support Project Manager in maintaining project file and site correspondence.
●Assist UBC management with other projects as requested.
●As required, provide site management activities per contract, to assigned sites that include, but not limited to:
●Proactive contact of sites to discuss study progress, track subject adherence to study visit schedule. Track drug/study supply inventory and process re-supply.
●Inquire regarding potential Serious Adverse Events that may not have been previously reported.
●Address/follow up with site regarding any questions or issues.
●Provide support with query resolution.
●Assure follow up activity regarding regulatory documents are reviewed in a timely manner once received from the Clinical Site Specialist.
●Provide CSS with any issue or follow up activities that need to occur with a site in regards to regulatory documents in a timely manner. Follow-up with CSS as needed.
Merck/DOCS April 2010 - October 2014
Lead TDOS
●Maintain and file all regulatory documentation (Trial Master File) for study drug release per the Food and Drug Administration guidelines and company policies and procedures.
●Required to maintain all Food and Drug Administration regulatory documentation for all clinical trial sites in the United States for audits.
●Performed UAT testing to ensure that all data flowed correctly into electronic Master File.
●Outsourced study document Archive Subject Matter Expert. Review of all CRO inventory sheets and File Transfer Forms for completeness and compliance for S.O.P. before submission to the Record Center for offsite storage.
●Negotiate site regulatory binder template at study start up. Once the template was approved by Project Manager print and assemble binders for shipment to clinical sites.
●Managed team consisting of four TDOS employees with any questions they had. Served as point of contact for the TDOS department when escalating issues and questions to upper management.
●QC and managed indexing of regulatory documents, IRB documents and informed consent into the Trial Master File properly and within the correct timeframe.
PSI Pharma support International (America) January 2006 - April 2010
Clinical Trial Assistant
●Maintain and file all regulatory documents (Trial Master File) for study drug release per the Food and Drug Administration guidelines and company policies and procedures.
●Required to maintain all Food and Drug Administration regulatory documentation in house for all clinical trial sites in the United States and Canada for audits and inspections.
●Sole responsibility for submission of all regulatory study documentation and study data to the Food and Drug Administration for drug approval and ongoing participation in the clinical trial.
●Once a Serious Adverse Event report was received from a clinical trial site, it was my responsibility to submit all documentation of the Serious Adverse Event to the Food and Drug Administration for drug safety review.
●Communication base for Food and Drug Administration, Clinical Research Assistants, Medical Monitors and third party vendors as well ass all clinical trial sites in the United States and Canada.
●Management of study drug release shipment and clinical trial drug and study specific supplies, as well as drug and supplies accountability for the United States and Canada.
● When awarded new contracts by pharmaceutical companies i managed study feasibility for multinational contract bid defense.
●On a continual basis I entered all study documentation into a study project management software program.
●Managed multinational clinical trial communications and teleconferences for weekly project updates.
●One of my biggest accomplishments while at PSI was to have the first multinational clinical trial sites cleared by the Food and Drug Administration and start receiving clinical trial drug and patient recruitment within a two month window.
●Prepare and attend on site study start up visits, that included creation of PowerPoint presentations and regulatory binders that contained study protocol, case report form, any and all additional forms and manuals.
Icon medical imaging October 2004 - January 2006
Clinical Trial Assistant
●One of my many responsibilities was to assist with project timelines and budgeting.
●At project start up, i was required assist with the development of project specific Procedure Manual and Staff Plan per client guidelines. Ensure all deadlines and company policies and procedures would be met on time and followed.
●One of my daily responsibilities was to communicate with the client and study sites for imaging data updates.
●Main point of communication for the client and Clinical Research Assistants.
●Track and ensure that proper medical images were received, generated and distributed weekly image data project reports.
●Managed large numbers of international Study Centers to ensure study protocols and timelines were strictly adhered to.
●Once imaging data was collected it needed to be read by many radiologist. Managed and monitored all off site Assessments/Blind reads for assigned projects.
●As part of Food and Drug Administration requirements i had to perform Quality Control of off site Assessments/Blind reads to ensure their accuracy and integrity.
●Per company practices it was my responsibility to update and maintain project tracking logs daily and generate tracking reports for clients on a weekly basis.
●Daily utilization of medical imaging software for image quality control per Food and Drug Administration regulations for image data submission and drug approval.
● Coordinate all project study team members, organized and reported internal and external weekly teleconferences and meetings to ensure that project was following projected timeline and budget.
Medical Communications Media November 1999 - October 2004
Senior Administrative Assistant
●Performed all data entry into an Access database that I created as required for project management fulfillments.
●As a daily requirement I was responsible for maintaining a 12-line phone system to insure that phone calls reached the proper department
●I performed all personal assistant duties for president and vice presidents of the company
●In supporting the sales team, I would responsible for typing all sales proposal and related documentation.
●To track the progress of the sales team I prepared all monthly sales reports for monthly company budget meetings.
●In my daily responsibilities I prepared all correspondence for the president and the vice presidents of the company, via phone, fax and email.
●On a daily basis I was responsible for filing,faxing, typing and general office duties.
●When accounts payable / receivable were busy I would provide assistance as necessary for that department.
●To insure timeline goals I would assist project managers ands all teams when necessary.
Office Team February 1997 - November 1999
Administrative Assistant
●Performed all aspects of Microsoft Office on a daily basis.
●I was required to perform all faxing,filing,typing and answering the phones.
●In my daily routine I preformed basic office duties such as providing support to my superiors.
EDUCATION
College August 1995- August 1997
Montgomery County Community College
Major in Biology
High School September 1990 - June 1995
Woodlynde School, Stratford, PA
CERTIFICATIONS
Food and Drug Administration Case Report Form part 11
Food and Drug Administration Case Report Form part 15
Food and Drug Administration Case Report Form part 21
Good Clinical Practices
Super user Veeva Vault
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