CRA Manager, Project Manager, Data Manager

QUALIFICATIONS SUMMARY: With an advanced degree, many years experience in the pharmaceutical industry, and excellent communication skills, I have been involved in clinical trials from first mention, through protocol development, CRF design and monitoring, to data lock, NDA preparation, and FDA approval.

PHARMACEUTICAL INDUSTRY EXPERIENCE

Clinical Team Leader, INC Research Inc, CNS group

• Project direction to CRAs: coordinated efforts to meet SOP and contractual visit requirements, monitoring CRA and data quality; Led training and CRA weekly meetings; Provided solutions to escalated issues; Reviewed and approved monitoring reports and clinical team responses to QA audits; Assisted team in integrating strategies from our central subject recruitment group’s advertisement campaign to meet enrollment on time

• Liaison between the PM and CRAs: provided regular updates both ways, attending weekly PM/CTL calls, interdepartmental project team calls, and sponsor calls

• Liaison between the Medical Monitor and sites: immediately reported safety, eligibility, or compliance issues to the project medical monitor, in appropriate format and detail, tracking these issues to the required, documented timely response back to CRAs and sites

• Resource projections and allocations: as new stages of study approached, or CRAs left or joined the team, I made regular assessments of future needs, and then worked with team to re-allocate efforts

• CRA Line Manager: annual evaluations, timecard/expense approvals, tracked training and PTO, contacted HR for hiring, promoting, and reassigning CRAs

• Special tasks:

o managed major study drug re-labeling effort across 60 sites by creating process, training, tracking, support, and resources to a team of 16 CRAs;

o became main contact for the IVRS drug supply vendor and brought service quality up to proper standards,

o managed “swat” effort to initiate 10 new sites within 2 months to bolster subject enrollment

o managed “swat” 5-day effort across 10 CRAs to clean external eDiary data, in time for data lock

• Studies using EDC, IVRS, eDiary, central lab, central/local IRBs, and central advertising campaign for patient recruitment

Associate Director, PPD, Phase IV group, Hypertension, Organ Transplant, Thrombocytopenia

• Line management and oversight of three project managers, who managed 20-30 CRAs

• Responsible for project budget, trial timeliness, resourcing, regulatory compliance, PM/CRA selection and training, site payments, interdepartmental cooperation, VP monthly updates, and client satisfaction

• Managed a Phase IV 10,000-subject trial to department’s first on-time data lock

• Implemented procedural and system efficiencies, as required by the Post-FDA approval “real use” safety/efficacy evaluations and surveys that involved thousands of sites and tens of thousands of patients

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• Used internal software to monitor: numbers of sites in different stages of regulatory approval, numbers of patients enrolled, number of CRFs collected, data quality, and CRA performance

• Assisted in creating the clinical components of bids to prospective clients, and negotiated high-dollar out-of-scopes with client

• Presented at off-site business development meetings for prospective clients

• Authored SOPs for the new Phase IV department

• Chaired interdepartmental/international effort to develop company SOPs to incorporate use of electronic data capture (EDC), to US and international trials, and authored the drafts

Contractor, Senior Clinical Research Monitor, Oncology

• Clinical Study Monitoring: site visits, data validation, regulatory document review, drug projections and accountability, training, contact reports, safety letters, site correspondence, site payments, site initiations and close-outs

• Trial Development: writing and refining protocols to meet company standards, assisting in investigator site selection, designing case record forms and casebooks, and coordinating with investigator personnel regarding trial design and trial initiation

• Electronic Data Capture (EDC) Specialist: design and implementation of data collection screens and edit checks, coordinating with programmers, training investigator and sponsor personnel, troubleshooting, and system validation

• Seminars Presented: GCP, EDC, monitoring

• Oncology experience: prostate, colorectal, melanoma, glioblastoma, breast

Clinical Research Associate, Oncology, Zeneca Pharmaceuticals (now AstraZeneca), Wilmington DE

• Clinical Study Monitoring: Though my load included twelve sites, the one visited by a QA auditor received the comment that it was the best site he had ever seen. I was also recognized for improving sites’ data quality and Safety reporting for sites assigned to me mid-study

• Electronic Data Capture (EDC) Coordinator: This key Phase III study was the first EDC study to be done at this company, and boasted the history-making data lock within a week of last visit.

• Contributor to New Drug Application (NDA) Reports

• Oncology Department Meeting Chairperson

• Liaison for Cooperative Group Studies

Senior Research Assistant, Centocor Inc., Malvern PA

• Product Development of Immuno-Diagnostic Imaging Agents included testing antibody product stability, analyzing purity, providing technical support for clinical trials, and contributing segments of the Product License Application.

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Visiting Researcher, University of Puerto Rico Mayaguez

EDUCATION

M.S., Molecular Bioscience and Biotechnology, Lehigh University, Bethlehem PA

Thesis: Immunotoxins in Cancer Chemotherapy: Effect of whole versus fragmented 17-1A antibodies on endocytosis, for purpose of delivering anti-MDR agent.

B.A., Biology, with Spanish Minor, University of Virginia, Charlottesville VA

CCRA certification by ACRP March 2008

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