PROFESSIONAL EXPERIENCE Innovation Pharmaceuticals (formerly Cellceutix Corporation), Beverly, MA
Clinical Trial Manager 2013-2014
Assisted with CTIX-BRI-204 Phase II ABSSSI Trial; 4 sites; 215 subjects; positive results
Clinical Trial Manager 2014-2018
Managed the CTIX-BRI-205 Phase II Oral Rinse for Oral Mucositis Trial from Concept/Protocol
to DBL (38 months); 18 sites; 61 randomized subjects (head & neck chemo/RT patients); ~30.5%
withdrawal rate; primary & secondary endpoints met (CSR still pending)
Study Manager, responsible for oversight of operational study deliverables, and day-to- day study operations and administration.
Assisted with creation & presentations of materials for SIVs
Assisted with preparation and made input to Investigator Brochure, Clinical Protocols, Informed Consents, manuals and forms needed for clinical trials
Handled contract negotiation of vendors for clinical supplies for trials as well as hotel & travel vendors for potential investigator meetings; also reviewed & approved trial invoicing; vendor management
Responsible for overall IRB submissions for oral mucositis study with central IRB
Made site visits as part of the team conducting SIVs, also made follow up visits to sites
(both trials)
Over-saw roll out of ClinTrialApp for Oral Mucositis study; responsible for updating documents & other information in app
Acted at TMF Process Owner assisting w/ resourcing, unitization and oversight of the Trial Master File system; also supervised Clinical Trial Associates (TMF Specialists) responsible for TMF, maintenance & reorganization of Beverly locked file room
Organized, ordered, stored and tracked expenditures of clinical supplies for Oral
Mucositis trial; oversaw consultant responsible for shipping clinical supplies
Assisted with preparation of electronic documents for FDA submissions (for several INDs & study serial submission) including fact checking, proofreading, reformatting, etc. utilizing MS Word and Adobe Acrobat.
Assist with compiling hybrid paper/electronic submissions to FDA including preparing desk copies (as needed) & shipping to FDA; also burned & tested CDs for submissions
Responsible creating and maintaining for all submission documents (1571, cover letters, etc.), preparation of submissions, shipping and filing of paper copies in Beverly.
Assisted with compilation, preparation of & submission of IND for Oral Mucositis
Member of ABSSSI & OM Phase II study teams, attended team meetings, conference calls, etc.; responsible for purchase, storage & shipping of all clinical study supplies.
Able to effectively prioritize assignments to meet long and short-term deadlines
Other duties as necessitated by business needs
BC Forward, Indianapolis, IN 2013
Contract assignment at Accenture – Regulatory Operations Associate (King of Prussia, PA)
Document level Quality Assurance for documents for inclusion in large FDA submissions. Tasks included (but not limited to) Image QA, Bookmarking, Hyperlinking and Identifying Issues (using proprietary software)
PolyMedix, Inc. Radnor, PA 2010-2013
Executive Assistant – supporting Clinical Operations/Regulatory Affairs and Research Teams
Performed key Executive Assistant tasks including calendars, travel arrangements (including air travel, hotels and ground transportation), processing of US Mail, FedEx, UPS, ordering office, kitchen & laboratory supplies as needed, prepared expense reports, internet searches for a wide range of requests, approve & track invoices, etc.
Able to present computer documents in attractive, accurate, and readable format in MS Word, Excel and PowerPoint
Participated with compilation of Common Technical Document (IND for ABSSSI)
Was assisting with compilation and preparation of IND for Oral Mucositis
Assisted with preparation and submission of Briefing Book for scheduled FDA Meetings
Assist with preparation of electronic documents for FDA submissions including fact checking, proofreading, reformatting, etc. utilizing MS Word and Adobe Acrobat (including some bookmarking and hyperlinks)
Assist with compiling paper submissions to FDA including preparing multiple copies &
shipping to FDA; also burned & tested CDs for submissions
Electronic filing for company records all FDA submissions; was responsible for controlling access to hard & electronic files to preserve integrity
Assisted with preparations for Due Diligence by potential investors including SmartRoom (see below) and compiling paper and electronic copies of reports & documents for onsite review
Responsible for uploads and removal of electronic documents in data SmartRoom; also providing access to viewers; maintaining order within the room
Was a member of the team selected to vet and procure a Trial Master File system; was responsible for maintenance of paper and electronic trial master files
Assisted with preparation of Investigator Brochure and Clinical Protocols
Assist study teams as needed; attend team meetings, conference calls, etc.
Assisted with contract negotiation of vendors for clinical supplies for trials
Organize Investigator Meetings (contracts to travel) and other meetings as needed (internal & external) including budget tracking, attendance, vendor management, purchase of meeting supplies & incentives, etc.
Able to effectively prioritize assignments to meet long and short-term deadlines
Strong work ethic and willingness to take ownership for wide-ranging responsibilities
Provided support to both the President and CFO of PolyMedix in the absence of their assistant
InVentive/MedFocus 2009-2010
Contract assignment at GSK Bio – supporting Procurement (King of Prussia, PA)
Scheduled meetings and presentations
Liaised with vendors for proposals
Prepared contracts and confidentiality agreements
Kept all files, assisted with mail and sent UPS/FedEx packages
Followed up with study teams with regard to contract management
Performed tasks as requested by Director of Procurement & study support staff
Contract assignment at Wyeth – supporting Clinical Team (Collegeville, PA)
Scheduled meetings utilizing GroupWise software (also used for email)
Travel arrangements including air travel, hotels and ground transportation
Excellent phone etiquette
Performed tasks as requested by team members & supervisory staff including coordinated with staff & team members in Cambridge, MA
Encorium Group, Inc. King of Prussia/Wayne, PA 2006-2008
Sr. Project Management Assistant – supporting Chief Operations Officer & VP of Clinical
Operations
Also supported Project Management Teams and Business Development Group
Assisted QA/QC with scanning of documents and reports for electronic filing
As part of project team was responsible for meeting minutes and agendas (MS Word), mailings, reports, correspondence, filing and other site selection and management activities (TrialWorks)
Functioned as Feasibility Coordinator to assist Business Development to gather data to prepare bids and for bid defense utilizing TrialWorks/MS Word and Outlook
Maintained investigator database in TrialWorks
Managed preparation of all department meetings including room reservations, catering services, audio/visual aids, handouts, room supplies etc.
Acted as meeting and special event planner (10 – 100+ persons) and all corresponding logistics in US and international (Finland)
Maintained appointment schedule (MS Outlook) by planning and scheduling meetings, conferences, teleconferences
Multi-city/multi-country (US, Canada, Finland, Denmark, UK, Germany) travel arrangements including air travel, hotels and ground transportation
Prepared expense reports including multi-currency as well as USD
Anticipated assistance needed by identifying problems, needs, options, and solutions before being asked
Performed task management, document tracking, mail processing and inventory/supplies
Able to effectively prioritize assignments to meet long and short-term deadlines
Able to present computer documents in attractive, accurate, and readable format in MS Word, Excel and PowerPoint
Vicuron Pharmaceuticals King of Prussia, PA 2001-2005
Executive Assistant to Executive Vice President of Scientific Affairs
Supported Director of Supply Chain Operations
Managed the calendar for the EVP, Directors and other department members, including updating of contacts utilizing MS Outlook
Handled all invoicing, purchase orders and needs as requested by Accounts Payable
Tracked department budget (MS Excel) and was liaison to Finance Department (managed accruals; assisted with budgets preparation)
Prepared correspondence, spreadsheets, presentations, etc. utilizing Microsoft Office Suite
(Outlook, Excel, Word and PowerPoint)
Managed preparation of all department meetings including room reservations, catering services, audio/visual aids, handouts, room supplies etc.
Sorted and distributes interoffice and US mail, FedEx, handled faxes, copying, etc.
Prepared and tracked all vacation requests
Multi-city/multi-country (US, Canada, UK, Italy) travel arrangements including air travel, hotels and ground transportation
Prepared expense reports including multi-currency as well as USD
Anticipated assistance needed by identifying problems, needs, options, and solutions before being asked
Performed task management, document tracking, mail processing and inventory/supplies
Able to effectively prioritize assignments to meet long and short-term deadlines
Strong work ethics and willingness to take ownership for wide-ranging responsibilities
Acted as a back up to other Assistants/Executive Assistants as needed
Covance Radnor, PA 1999-2001
Administrative Assistant to two Senior Managers/Recruiters
Prepared correspondence utilizing MS Word to potential candidates
Collected and prepared data in pre and post interview process
Set up interview schedules and wrap-up meetings utilizing MS Outlook
Created candidate tracking spreadsheets utilizing MS Excel
Phone coverage, message taking, etc. for managers
Represented company at college job fairs
Prepared and managed new employee orientation
Sorted and distributed interoffice, US mail and FedEx
Assisted with preparation of archive information stored off-site
Assisted with entering recruiting needs in HRIS internet-based resume system
Updated company website with job postings
Chiltern/Theorem/Omnicare Clinical Research (IBAH) King of Prussia, 1995-1999
Administrative Assistant to Vice President of Data Management
Also supported 10 managers (department of 100+ persons)
Handled domestic (multi-city) travel arrangements
Assisted with entering revenue/projection into proprietary database on monthly basis
Kept attendance, vacation logs and time sheet completion for department staff and temporary help/contractors utilizing MS Excel
Assisted all members of department with completion of timesheet data in proprietary database
Typed correspondence and prepared mailings (MS Word (for department head and managers
Assisted with phone coverage, message taking, etc. for managers as well as covering for receptionist
Handled with arrangements for meetings, travel, luncheons, etc.
Sorted and distributed interoffice and US mail, FedEx
Responsible for invoicing for supplies, temporary help, consultants, etc.
Prepared archive information for off-site storage
Assisted with data entry to meet sponsor guidelines as needed
Assisted Regulatory Affairs group with preparing printed materials for FDA submissions
EDUCATION:
Katherine Gibbs Secretarial School, Philadelphia, PA – Graduate 1982
Clinical Trial Manager 2013-2014
Assisted with CTIX-BRI-204 Phase II ABSSSI Trial; 4 sites; 215 subjects; positive results
Clinical Trial Manager 2014-2018
Managed the CTIX-BRI-205 Phase II Oral Rinse for Oral Mucositis Trial from Concept/Protocol
to DBL (38 months); 18 sites; 61 randomized subjects (head & neck chemo/RT patients); ~30.5%
withdrawal rate; primary & secondary endpoints met (CSR still pending)
Study Manager, responsible for oversight of operational study deliverables, and day-to- day study operations and administration.
Assisted with creation & presentations of materials for SIVs
Assisted with preparation and made input to Investigator Brochure, Clinical Protocols, Informed Consents, manuals and forms needed for clinical trials
Handled contract negotiation of vendors for clinical supplies for trials as well as hotel & travel vendors for potential investigator meetings; also reviewed & approved trial invoicing; vendor management
Responsible for overall IRB submissions for oral mucositis study with central IRB
Made site visits as part of the team conducting SIVs, also made follow up visits to sites
(both trials)
Over-saw roll out of ClinTrialApp for Oral Mucositis study; responsible for updating documents & other information in app
Acted at TMF Process Owner assisting w/ resourcing, unitization and oversight of the Trial Master File system; also supervised Clinical Trial Associates (TMF Specialists) responsible for TMF, maintenance & reorganization of Beverly locked file room
Organized, ordered, stored and tracked expenditures of clinical supplies for Oral
Mucositis trial; oversaw consultant responsible for shipping clinical supplies
Assisted with preparation of electronic documents for FDA submissions (for several INDs & study serial submission) including fact checking, proofreading, reformatting, etc. utilizing MS Word and Adobe Acrobat.
Assist with compiling hybrid paper/electronic submissions to FDA including preparing desk copies (as needed) & shipping to FDA; also burned & tested CDs for submissions
Responsible creating and maintaining for all submission documents (1571, cover letters, etc.), preparation of submissions, shipping and filing of paper copies in Beverly.
Assisted with compilation, preparation of & submission of IND for Oral Mucositis
Member of ABSSSI & OM Phase II study teams, attended team meetings, conference calls, etc.; responsible for purchase, storage & shipping of all clinical study supplies.
Able to effectively prioritize assignments to meet long and short-term deadlines
Other duties as necessitated by business needs
BC Forward, Indianapolis, IN 2013
Contract assignment at Accenture – Regulatory Operations Associate (King of Prussia, PA)
Document level Quality Assurance for documents for inclusion in large FDA submissions. Tasks included (but not limited to) Image QA, Bookmarking, Hyperlinking and Identifying Issues (using proprietary software)
PolyMedix, Inc. Radnor, PA 2010-2013
Executive Assistant – supporting Clinical Operations/Regulatory Affairs and Research Teams
Performed key Executive Assistant tasks including calendars, travel arrangements (including air travel, hotels and ground transportation), processing of US Mail, FedEx, UPS, ordering office, kitchen & laboratory supplies as needed, prepared expense reports, internet searches for a wide range of requests, approve & track invoices, etc.
Able to present computer documents in attractive, accurate, and readable format in MS Word, Excel and PowerPoint
Participated with compilation of Common Technical Document (IND for ABSSSI)
Was assisting with compilation and preparation of IND for Oral Mucositis
Assisted with preparation and submission of Briefing Book for scheduled FDA Meetings
Assist with preparation of electronic documents for FDA submissions including fact checking, proofreading, reformatting, etc. utilizing MS Word and Adobe Acrobat (including some bookmarking and hyperlinks)
Assist with compiling paper submissions to FDA including preparing multiple copies &
shipping to FDA; also burned & tested CDs for submissions
Electronic filing for company records all FDA submissions; was responsible for controlling access to hard & electronic files to preserve integrity
Assisted with preparations for Due Diligence by potential investors including SmartRoom (see below) and compiling paper and electronic copies of reports & documents for onsite review
Responsible for uploads and removal of electronic documents in data SmartRoom; also providing access to viewers; maintaining order within the room
Was a member of the team selected to vet and procure a Trial Master File system; was responsible for maintenance of paper and electronic trial master files
Assisted with preparation of Investigator Brochure and Clinical Protocols
Assist study teams as needed; attend team meetings, conference calls, etc.
Assisted with contract negotiation of vendors for clinical supplies for trials
Organize Investigator Meetings (contracts to travel) and other meetings as needed (internal & external) including budget tracking, attendance, vendor management, purchase of meeting supplies & incentives, etc.
Able to effectively prioritize assignments to meet long and short-term deadlines
Strong work ethic and willingness to take ownership for wide-ranging responsibilities
Provided support to both the President and CFO of PolyMedix in the absence of their assistant
InVentive/MedFocus 2009-2010
Contract assignment at GSK Bio – supporting Procurement (King of Prussia, PA)
Scheduled meetings and presentations
Liaised with vendors for proposals
Prepared contracts and confidentiality agreements
Kept all files, assisted with mail and sent UPS/FedEx packages
Followed up with study teams with regard to contract management
Performed tasks as requested by Director of Procurement & study support staff
Contract assignment at Wyeth – supporting Clinical Team (Collegeville, PA)
Scheduled meetings utilizing GroupWise software (also used for email)
Travel arrangements including air travel, hotels and ground transportation
Excellent phone etiquette
Performed tasks as requested by team members & supervisory staff including coordinated with staff & team members in Cambridge, MA
Encorium Group, Inc. King of Prussia/Wayne, PA 2006-2008
Sr. Project Management Assistant – supporting Chief Operations Officer & VP of Clinical
Operations
Also supported Project Management Teams and Business Development Group
Assisted QA/QC with scanning of documents and reports for electronic filing
As part of project team was responsible for meeting minutes and agendas (MS Word), mailings, reports, correspondence, filing and other site selection and management activities (TrialWorks)
Functioned as Feasibility Coordinator to assist Business Development to gather data to prepare bids and for bid defense utilizing TrialWorks/MS Word and Outlook
Maintained investigator database in TrialWorks
Managed preparation of all department meetings including room reservations, catering services, audio/visual aids, handouts, room supplies etc.
Acted as meeting and special event planner (10 – 100+ persons) and all corresponding logistics in US and international (Finland)
Maintained appointment schedule (MS Outlook) by planning and scheduling meetings, conferences, teleconferences
Multi-city/multi-country (US, Canada, Finland, Denmark, UK, Germany) travel arrangements including air travel, hotels and ground transportation
Prepared expense reports including multi-currency as well as USD
Anticipated assistance needed by identifying problems, needs, options, and solutions before being asked
Performed task management, document tracking, mail processing and inventory/supplies
Able to effectively prioritize assignments to meet long and short-term deadlines
Able to present computer documents in attractive, accurate, and readable format in MS Word, Excel and PowerPoint
Vicuron Pharmaceuticals King of Prussia, PA 2001-2005
Executive Assistant to Executive Vice President of Scientific Affairs
Supported Director of Supply Chain Operations
Managed the calendar for the EVP, Directors and other department members, including updating of contacts utilizing MS Outlook
Handled all invoicing, purchase orders and needs as requested by Accounts Payable
Tracked department budget (MS Excel) and was liaison to Finance Department (managed accruals; assisted with budgets preparation)
Prepared correspondence, spreadsheets, presentations, etc. utilizing Microsoft Office Suite
(Outlook, Excel, Word and PowerPoint)
Managed preparation of all department meetings including room reservations, catering services, audio/visual aids, handouts, room supplies etc.
Sorted and distributes interoffice and US mail, FedEx, handled faxes, copying, etc.
Prepared and tracked all vacation requests
Multi-city/multi-country (US, Canada, UK, Italy) travel arrangements including air travel, hotels and ground transportation
Prepared expense reports including multi-currency as well as USD
Anticipated assistance needed by identifying problems, needs, options, and solutions before being asked
Performed task management, document tracking, mail processing and inventory/supplies
Able to effectively prioritize assignments to meet long and short-term deadlines
Strong work ethics and willingness to take ownership for wide-ranging responsibilities
Acted as a back up to other Assistants/Executive Assistants as needed
Covance Radnor, PA 1999-2001
Administrative Assistant to two Senior Managers/Recruiters
Prepared correspondence utilizing MS Word to potential candidates
Collected and prepared data in pre and post interview process
Set up interview schedules and wrap-up meetings utilizing MS Outlook
Created candidate tracking spreadsheets utilizing MS Excel
Phone coverage, message taking, etc. for managers
Represented company at college job fairs
Prepared and managed new employee orientation
Sorted and distributed interoffice, US mail and FedEx
Assisted with preparation of archive information stored off-site
Assisted with entering recruiting needs in HRIS internet-based resume system
Updated company website with job postings
Chiltern/Theorem/Omnicare Clinical Research (IBAH) King of Prussia, 1995-1999
Administrative Assistant to Vice President of Data Management
Also supported 10 managers (department of 100+ persons)
Handled domestic (multi-city) travel arrangements
Assisted with entering revenue/projection into proprietary database on monthly basis
Kept attendance, vacation logs and time sheet completion for department staff and temporary help/contractors utilizing MS Excel
Assisted all members of department with completion of timesheet data in proprietary database
Typed correspondence and prepared mailings (MS Word (for department head and managers
Assisted with phone coverage, message taking, etc. for managers as well as covering for receptionist
Handled with arrangements for meetings, travel, luncheons, etc.
Sorted and distributed interoffice and US mail, FedEx
Responsible for invoicing for supplies, temporary help, consultants, etc.
Prepared archive information for off-site storage
Assisted with data entry to meet sponsor guidelines as needed
Assisted Regulatory Affairs group with preparing printed materials for FDA submissions
EDUCATION:
Katherine Gibbs Secretarial School, Philadelphia, PA – Graduate 1982