SUMMARY OF EXPERIENCE

• 14 years clinical research experience, including 8 years direct pharmaceutical industry experience
• Strong writing and quality control review skills, including protocols and clinical study reports
• Regulatory documentation review for Briefing package, Investigator Brochure, IND annual reports and FDA correspondence
• Effective organizational, communication and time management skills
• Goal oriented, self motivated with attention to detail and leadership ability
• Ability to work well both independently and in team environment
• Proactive approach to meeting objectives

EDUCATION

Masters in Biology
Thesis: Effects of Mutant Adenoviruses on the Viability of Multiple Myeloma Cell Lines

Bachelors in Biological Science
Alpha Zeta Honors/Service Fraternity

PROFESSIONAL EXPERIENCE

Confidential, March 2009- Present
Clinical Project Manager Dermatology

• Conceives and writes clinical study protocols with an appropriate methodology integrated from the clinical development plan and regulatory strategy
• Quality Assurance Reviews of clinical development regulatory documents (i.e. Briefing package, investigator brochure, protocols, etc.)
• Coordinates all clinical and operational activities globally within the planned time frame / budget and in the sought quality according to internal SOP and Good Clinical Practices
• Manages compliance of all submissions to the Clinical Trials.gov Registry

Confidential, Bridgewater, NJ June 2006-March 2009
Sr. Clinical Trial Manager Oncology July 2008- March 2009
Clinical Trial Manager Oncology (perm) Sept. 2006- July 2008 Clinical Trial Manager (contract) June 2006- Sept. 2006

• Managed Study Management Team (SMT) in the Protocol Development Process
• Managed SMT in the consistent planning, implementation and successful completion of operational clinical research activities
• Interfaced with relevant departments to facilitate operational activities including but not limited to:
• operational feasibility and risk assessments
• development of study specifications/scope of work/project timeline for Request for Proposal (RFP) development.
• bid defense, vendor selection and contract execution
• forecasted and maintained adequate Clinical Supplies
• development and maintenance of study budget and timelines
• planned investigator meetings
• managed development of Study plans, i.e.Monitoring Plan/DMP/ SAP
• managed process associated with safety reporting
• vendor and site management
• database and TMF management
• Ensured clinical trials were conducted in accordance with State and Federal regulations, Good Clinical Practice regulations, and internal Standard Operating Procedures
• Facilitated and actively participated in process improvement initiatives, taskforces and committees within Clinical Operations and cross-functionally
• Provided leadership/mentorship to the Assoc. CTMs and CTCs in study management and conduct of clinical studies

Confidential, June 2004- June 2006
Senior Clinical Research Scientist, Oncology/Endocrinology

• Independently wrote Clinical Trial Protocols, Informed consent as well as study related source documents
• Managed vendor in the production of the following manuscripts (unpublished):
• Marie Ciardella, M.S., LyLe Tran, M.D., Gladys Urbanowitz, M.B.A. Phase I, Open Label, Single-Center Study to Evaluate the Biodistribution and Pharmacokinetics of 86Y-SMT487 Administered by Intravenous Infusion with Coadministration of Amino Acids to Patients with Somatostatin Receptor-Positive Malignant Tumors
• Marie Ciardella, M.S., Gladys Urbanowitz, M.B.A., LyLe Tran, M.D. A Phase II, Open-Label, Multicenter Study to Evaluate the Efficacy of 90Y-SMT487 Administered Intravenously to Patients with Advanced Metastatic Cancers Expressing Somatostatin Receptors as Determined by OctreoScan® Scintigraphy
• Marie Ciardella, M.S., Lyle Tran, M.D., Gladys Urbanowitz, M.B.A A Phase I, Open-Label, Maximum Tolerated Single-Cycle and Four-Cycle Dose-Finding Study to Evaluate the Safety and Tolerability of 90Y-SMT487 Administered by Intravenous Infusion to Patients with Refractory Somatostatin Receptor-Positive Tumors
• Marie Ciardella, M.S., Lyle Tran, M.D., Gladys Urbanowitz, M.B.A. A Phase II Open-Label Multicenter Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Patients with OctreoScanÒ Positive Functional Pancreatic Endocrine Tumors (PET)
• Marie Ciardella, M.S., Gladys Urbanowitz, M.B.A., Lyle Tran, M.D. A Phase II Open-Label Multicenter Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Patients with Symptomatic Malignant Carcinoid Tumors
• Managed multidisciplinary and global project teams to initiate and coordinate all aspects of study start up through completion of clinical study report for global clinical trials
• Interacted with global line units in support of study budget negotiation and contractual agreements
• Electronic data capture (EDC) proficiency
• Facilitated development of Investigator ePortal
• Ability to recognize safety and efficacy data trends independently. Knowledge of clinical trial design, statistics and pharmacokinetics
• Contributed in monitoring safety, eligibility, enrollment and data consistency
• Facilitated the preparation of several clinical study reports, publications and manuscripts
• Management of external vendors such as CROs and Central labs
• Managed the creation and implementation of a Data Safety Monitoring Board
• Managed all aspects regarding global Investigator Meeting organization, training and presentations
• Ensures compliance with current Standard Operating Procedures
• Ensures project timelines were met by closely monitoring study activities and resources
• Proficient in drug development process, GCP/FDA and ICH regulatory requirements. Knowledge of the medical, scientific and clinical research techniques of the assigned areas
• Team participant awarded Pediatric Exclusivity for investigational compound

Confidential, New Brunswick, NJ March 2002 to June 2004
Research Teaching Specialist V

• Collaborated on a project within a translational research lab that entailed the use of a genetically engineered adenovirus as a “smart bomb”. Demonstrated a particular adenovirus caused apoptosis in certain types of cancer cells while leaving healthy cells unharmed.
• Skills employed: Tissue culture, Gel electrophoresis, Blotting techniques

• Responsible for initiating, coordinating and managing clinical trials (phase I –III) for NIH, Cooperative group, Industry as well as in-house studies. Includes Case Report Form design and completion.
• Ensured adequate reporting of patient accrual updates, serious adverse events and protocol deviations
• Study Liaison for Tumor Study group; managed eligibility questions and treatment related issues
• Responsible for acting as liaison between physician and patient in the initiation, inception, conduct and completion of all aspects of clinical trial. This included: facilitating patient enrollment, ensuring eligibility criteria met, obtaining appropriate randomization to study arms, obtaining study medications, answering patient/sponsor queries, providing patient instruction, collecting and reporting data
• Participated in internal monitoring audits
• Responsible for orienting and mentoring new clinical research associates
• Coordinated collection and shipment of PK samples according to protocol guidelines
• Data summation and Quality Assurance reviewer for the following:

Manuscripts:

• DiPaola RS, Chenven ES, Shih WJ, Lin Y, Amenta P, Goodin S, Shumate A, Rafi MM, Capanna T, Ciardella M, Cummings KB, Aisner J., Todd M. Mitoxantrone in patients with prostate specific antigen progression after local therapy for prostate cancer. Cancer 2001 Oct;8(92):2065-71.
• DiPaola RS, Rubin E, Rinehart J, Nemunaitis J, Ebbinghaus S, Capanna T, Ciardella M, Fontiane M, Adams N, Williams A, Schwartz M, Winchell G, Wickersham K, Deutsch P, Yao S. Characterization of a novel prostate specific antigen activated peptide-doxorubicin conjugate in patients with prostate cancer. The Journal of Clinical Oncology, 2002 April; 7(20): 1874-79.
• DiPaola RS, Rubin E, Toppmeyer D, Eid J, Butzbach D, Dvorzhinski D, Capanna T, Ciardella M, Shih W, Goodin S, Todd M. Gemcitabine combined with sequential paclitaxel and carboplatin in patients with urothelial cancers and other advanced malignancies. Medical Science Monitor, 2003 February; 9 (2): PI 5-11.
• Strair R, Schaar D, Medina D, Todd M, Aisner J, DiPaola R, Manago J, Knox B, Jenkinson A, Senzon R, Baker C, Dudek L, Ciardella M, Kuriyan M, Rubin A, Lattime E. Anti-Neoplastic Effects of Partially HLA-Matched Irradiated Blood Mononuclear Cells in Patients with Renal Cell Carcinoma. The Journal of Clinical Oncology, 2003 October; 21 (20):3785-91.
• Goodin S, Capanna T, Ciardella M, Shih W, Todd MB, DiPaola RS. A phase II trial of taxotere and navelbine in patients with HRPC with and without prior chemotherapy. Cancer Chemotherapy Pharmacology. 2005 Aug;56(2):199-204.

Abstracts:

• DiPaola RS, Ebbinghaus S, Nemunaitis J, McCullough J, Ciardella M, Adams N, Williams A, Garsky V, Wong B, Defeo-Jones D, Jones D, Jones R, Schwartz M, Winchell G, Arena C, Deutsch P, Yao S. Phase I and Pharmacokinetic Study of L377202, a Novel Peptide Doxorubicin Conjugate, in Patients with Advanced Prostate Cancer. Proceedings from the American Society of Clinical Oncology, 19:1471, 2000.
• DiPaola RS, Rinehart J, Nemunaitis J, Ciardella M, Goodin S, Adams N, Williams A, Schwartz M, Winchell G, Wickersham K, Deutsch P, Dual D, Gleason D, Yao S. A phase I/II trial of a PSA activated peptide-doxorubicin conjugate, with and without prednisone, in patients with HRPC. Proceedings from the American Society of Clinical Oncology, 120:727, 2001.
• Strair R, Conney A, Chang R, Aisner J, Chin KV, Schaar D, Goodell L, Rabson A, Lubiner E, Knox B, Senzon R, M Ciardella. 12-O-Tetradecanoylphorbol-13-Acetate (TPA) for Patients with Relapsed/Refractory Hematologic Malignancies/Bone Marrow Disorders. Proceedings from the American Society of Clinical Oncology :333, 2001.
• Goodin S, Rao KV, Engle EA, Kane M, Capanna T, Ciardella M, Todd MB, DiPaola RS. A phase II study of docetaxel and vinorelbine in hormone refractory prostate cancer (HRPC) with and without prior chemotherapy. Proceedings from the American Society of Clinical Oncology :2459, 2002.
• DiPaola RS, Rubin E, Toppmeyer D, Eid J, Butzbach D, Dvorzhinski D, Capanna T, Ciardella M, Shih WJ, Goodin S, Todd MB. Sequential paclitaxel/gemcitabine followed by carboplatin in patients with urothelial cancers and other advanced malignancies. Proceedings from the American Society of Clinical Oncology :766, 2002.

Poster Presentations:

• Robert S DiPaola, J Rinehart, J Nemunaitis, M Ciardella, S Goodin, N Adams, A Williams, M Schwartz, G Winchell, M Wickersham, P Deutsch, D Dula, D Gleason, S Yao. (2000, April). A Phase I and II Trial of PSA Activated Peptide –Doxorubicin Conjugate, With and Without Prednisone, in Patients with Hormone Refractory Prostate Cancer. Poster presented at the 2001 Annual Retreat on Cancer Research in New Jersey. (Also presented at ASCO.)
• DG Schaar, A Conney, L Goodell, R Changl, KV Chin, A Rabson, J Hsu, B Knox, R Senzon, M Ciardella, R Stair. (2000, April). 12-O-Tetradecanoylphorbol-13-Acetate (TPA) for Patients With Relapsed/Refractory Hematologic Malignancies/Bone Marrow Disorders. Poster presented at the 2001 Annual Retreat on Cancer Research in New Jersey.

Guest Lecture:

“Data Management”. Biannual in-service to affiliate members of The Cancer Institute of New Jersey. New Brunswick, NJ.

“Cross Functionality of Line Functions within the Clinical Trial Process”. Medical Affairs Exchange Forum. Sanofi-aventis US Medical Affairs Department.

References Available Upon Request