Project Manager Management
Resume:
ROCHELLE LAVENHOUSE
Newark, NJ *****
*******@*******.***
Professional Profile:
• Clinical Research Professional with 13 years’ experience of exceptional leadership, organizational, oral,
written communication, interpersonal, analytical, problem resolution skills, who thrives in both
independent and collaborative work environments
• Advanced Technical Skills: Strong knowledge of Windows, Word and Excel based operating systems
and software applications. Experience with Clinical Trial Management Systems (Spectrum and
Harmony), vendor management, (CROs, IRB, Drug Depot, IVRS, etc.), and Grant Plan
• Solid experiences working with cross functional teams and diverse cultures to accomplish goals.
•Draft study budgets for approximately 4 countries and 1,000 sites located both globally and domestically
and are currently participating in 5 clinical trials sponsored by Merck.
• Experience working in Emerging Market countries on studies with sites located in China, Philippines,
Columbia and Mexico.
• Experience in Phase I-IV study start-up, study maintenance and study close-out in a variety of
therapeutic areas including, Gastroenterology, Respiratory, Oncology, Diabetes, Osteoporosis,
Immunology, Autoimmune, Infectious Diseases, Ophthalmology, Weight Loss, Endocrine, Pain and
Women's Healthcare
PROFESSIONAL EXPERIENCE
Merck Research Laboratories, Rahway, NJ 01/13 – 08/14
Global Study and Site Budget Specialist, III (Contract)
• Worked with Project Management and other team members on Phase III Respiratory (Allergy, and
Asthma), Osteoporosis, Endocrine, Immunology and Pain studies during study-start-up, maintenance
and close-out
• Develop country and site level budgets utilizing Grant Plan, to be negotiated with investigators
supporting the trial.
• Serve as the primary point of contact for the study team for all issues and questions related to the Study
Budget, Site Budget Development and all Site related payments in one or more programs
• Review and approve vendor invoices as they are received
• Manage spending against the budget and provide forecasts on future spend in support of quarterly
exercises
• Analyzed vendor bids and seek opportunities to minimize spend
• Ensure all budget amounts fall within Fair Market Value and are 100% compliant with domestic and
foreign laws.
Parexel, Billerica, MA 04/12 – 06/12
Clinical Trial Specialist, II/ (Remote/Contract)
• Worked with Project Management and other team members on Phase II-III Respiratory (Allergy,
Asthma and COPD,) Ophthalmology (Macular Edema) and Weight Loss (Major Adverse
Cardiovascular Events) studies during study-start-up.
• Conducted feasibility and site pre qualification activities
• Reviewed/approved and customized site specific Informed Consent Forms (ICFs)
• Reviewed, maintained and tracked electronic regulatory and amendment documents for accuracy and
completeness (i.e. Confidentiality Agreements, Protocol Signature Pages, Clinical Study Agreements,
IRB approvals, 1572, CVs, Medical License, Financial Disclosure, Informed Consents and HIPAA,
etc).
• Entered and maintained site level data into the CTMS Impact Harmony database.
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ROCHELLE LAVENHOUSE tel: 908-***-**** email: *******@*******.***
• Ensured that all assigned tasks are conducted in accordance with FDA regulations, ICH guidelines,
GCPs and company’s SOP.
Merck Research Laboratories (formerly Schering-Plough), Kenilworth, NJ 06/09 – 12/10
Sr. Clinical Trial Specialist/Sr. In-House Clinical Research Associate (Contract)
• Worked with Project Management and other team members on Phase III Respiratory (Allergy and
COPD) studies during study-start-up, maintenance and close-out.
• Managed CROs and vendors as direct reports; ensuring adherence to scope of work within timelines
and budget.
• Participated and assisted with site selection and operational feasibility.
• Prepared and managed internal/external meetings as needed to ensure that all timelines are met.
• Wrote clinical trial meeting minutes; sent to Project Manager for final review.
• Participated and assisted with development of budgets and contracts.
• Assisted with the preparation and review of the draft Clinical Study Report.
• Reviewed, maintained and tracked electronic regulatory and amendment documents for accuracy and
completeness (i.e. Confidentiality Agreements, Protocol Signature Pages, Clinical Study Agreements,
IRB approvals, 1572, CVs, Medical License, Financial Disclosure, Informed Consents and HIPAA,
etc).
• Managed and tracked IRB submissions.
• Reconciled site and study financials upon study completion.
• Assisted with reports for internal and external communications.
• Managed and processed initial and re-supply requests for clinical and non-clinical supplies for sites.
• Reviewed and tracked paper Case Report Forms for accuracy and completion upon submission to
ClinDoc for filing; issued data queries and assisted with resolving investigative site/data queries as
necessary
• Performed and documented user acceptance testing (UAT) on various systems and instruments (i.e.
Spirometry equipment).
• Entered, maintained and assisted with protocol/site level data into the CTMS Spectrum database.
• Ensured that all assigned tasks are conducted in accordance with FDA regulations, ICH guidelines,
GCPs and company’s SOP.
Tobira Therapeutics, Princeton, NJ 09/08 – 12/08
Clinical Project Associate (Downsized)
• Coordinated with the Chief Medical Officer, VPs and Director of Clinical Operations, and other team
members on a Phase I-II Infectious Disease (HIV/AIDS) study during pre-clinical and study start-up.
• Managed and processed vendor payments in collaboration with Finance.
• Worked with the Directors, VPs and Finance to ensure that vendor payment requests are made promptly
in accordance within the established budget.
• Maintained and updated the company internal Clinical Library.
• Reviewed and edited the draft protocol under the Director of Regulatory’s supervision.
NYCOMED (formally Altana Pharma), Florham Park, NJ 03/06- 10/07
Clinical Trial Associate/In-house CRA (Downsized due to merger)
• Worked with Project Management and other team members on a Phase III Respiratory (COPD) study
during study start-up, maintenance and close-out.
• Participated and assisted with site selection and operational feasibility.
• Collected, tracked and filed Subject Enrollment Fax updates.
• Documented and monitored patient visits and overall study progress using CLIMON and PharmaDocs
databases.
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ROCHELLE LAVENHOUSE tel: 908-***-**** email: *******@*******.***
• Reviewed, maintained and tracked electronic regulatory and amendment documents for accuracy and
completeness (i.e. Confidentiality Agreements, Protocol Signature Pages, Clinical Study Agreements,
IRB approvals, 1572, CVs, Medical License, Financial Disclosure, Informed Consents and HIPAA,
etc.) using PharmaDocs database.
• Reviewed/approved and customized site specific Informed Consent Forms (ICFs)
• Managed and tracked IRB submissions.
• Managed vendors for IVRS, clinical supplies, IRB, etc.
• Managed site recruitment by acting as a primary point of contact with investigative sites.
• Interacted with Field Monitors on site issues.
• Trained new colleagues on study specific procedures and on various databases (i.e. PharmaDocs)
• Reviewed monitoring reports for accuracy and completion.
• Participated in team meetings and provided study status updates.
• Managed and processed initial and re-supply requests for clinical and non-clinical supplies for sites.
• Participated on both Site Initiation and Interim Co-monitoring Visits.
PRA International (CRO), Eatontown, NJ 05/05 – 02/06
Clinical Operations Specialist (Site closed)
• Supported the clinical research team in Phase III Gastroenterology (GERD) and Colorectal Cancer
(Oncology) studies during study start-up, maintenance and close-out.
• Participated and assisted with site selection and operational feasibility.
• Reviewed and tracked paper Case Report Forms for accuracy and; issued data queries and assisted with
resolving investigative site/data queries as necessary.
• Managed site recruitment by acting as a primary point of contact with investigative sites.
Clinical Trial Assistant (All Contract)
Sanofi-Aventis, Bridgewater, NJ 10/04 – 05/05
Abbott Laboratories, Parsippany, NJ 05/04- 10/04
Genmab, Inc., Princeton, NJ 06/02- 02/04
Bayer (formally Berlex Laboratories), Montville, NJ 08/01- 05/02
Supported the clinical research teams in various Phase II-III studies Immunology (Psoriasis), Autoimmune
(Rheumatoid Arthritis), Oncology (Cutaneous T-Cell Lymphoma/Solid Tumor), Osteoporosis, Infectious
Disease, Diabetes and Women’s Healthcare
• Assisted with all IND/NDA submissions
• Coordinated study files and Case Report Forms for review/submission to document storage.
• Organized appendices and proof study summaries for all submissions under supervision.
• Managed site recruitment by acting as a primary point of contact with investigative sites.
• Tracked all Adverse Events and Serious Adverse Events using Microsoft Excel spreadsheet.
• Managed vendors for IRB and clinical supplies.
• Managed internal and external meetings.
• Reviewed, maintained and tracked electronic regulatory and amendment documents for accuracy and
completeness (i.e. Confidentiality Agreements, Protocol Signature Pages, Clinical Study Agreements,
IRB approvals, 1572, CVs, Medical License, Financial Disclosure, Informed Consents and HIPAA,
etc.)
• Prepared, distributed and tracked Regulatory Packages/binders to sites (i.e., Protocol, Investigator
Brochure, 1572, etc)
• Reviewed and edited draft protocol under the Project Manager’s supervision.
• Entered investigational site information into IMPACT and MAPPS.
• Processed and tracked external vendor contracts, investigator grants, and site/vendor payments.
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ROCHELLE LAVENHOUSE tel: 908-***-**** email: *******@*******.***
• Created, maintained, archived and scanned documents for the Trial Master File.
VOLUNTEER ACTIVITIES
Brand New Day Community Development, Elizabeth NJ 08/11 – 04/12
Administrative Assistant (Volunteer)
• Supported the Chief Development Officer by providing administrative support to the staff. These duties
include but are not limited to: data entry, grant research, typing and filing,
• Typed and word processed documents as needed.
• Updated and maintained mailing lists/database
• Other duties as assigned
TECHNICAL SKILLS
MS Office 2007 (Word, Excel, Access, PowerPoint and Outlook) Adobe, SharePoint, MS Project 2010, Lotus
Notes Internet/Intranet, Clinical Trial Management Systems (Spectrum and Impact Harmony),
Oracle Clinical Data Management, PMED, MAPPS, Documentum, CLIMON, PharmaDocs, and Grant Plan
EDUCATION
Avtech Institute, South Plainfield, NJ 2011-2012
Courses: PMP (Project Management Professional)
Microsoft Project
Oracle Clinical: Data Management and Electronic Data Capture (EDC)
Berkeley College, West Paterson, NJ 2005-2009
Bachelor of Science in Business Administration
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