PROJECT MANAGER Resume Reston, VA - Hire IT People

SUMMARY

Medical Graduate with over 15 years of thriving in life science and health IT focused applications’ development.
Confidential manages multiple projects at FDA and occasionally wears a hat of Business Analyst, with proven facilitation, organizational and expert requirements gathering skills.
She also excels at creating presentation and training materials; loves challenge and new technology and is a true and exceptional liaison between stakeholders, business units, technology groups and support teams.
Requirements: gathering, analysis, verification and documentation using Agile methodologies
Clinical data management and QA
GCP, ICH and FDA guidelines user guides, wiki, training plans
Graphic UI for clinical research applications user acceptance
User training: in - class and web based
Project Management
Virtual teams
Industry standards and dictionaries such as CDISC, HL7, NCI EVS, MedDRA, LOINC
Process Modeling Tools: Rational Requisite Pro, Rational ClearQuest, MS Visio, Cmaps
Content Management Tools
NIH Tools: CRISP, RePORT, QVR, RCDC

PROFESSIONAL EXPERIENCE:

Confidential

PROJECT MANAGER

Responsibilities:

Successfully leads two projects and a key contributor to a third one - develops, monitors and controls project schedule, budget and resource estimations
Analyzes FDA regulatory reviews, datasets and other materials across multiple therapeutic areas
Organizes, conducts, facilitates and documents requirements gathering sessions with FDA reviewers
Conducts gap analysis between FDA recommendations and SDO guides
Analyzes and recommends improvements to the customer’s knowledge management processes
Contributes to article’s content in preparation for its submission by an FDA reviewer
Contributes to writing and reviewing IBM proposals on various services for FDA
Management of subcontractors

Confidential

MANAGING CONSULTANT

Responsibilities:

Contributed to the development of risk management processes’ enhancements for Centers for Medicare and Medicaid Services Business Operations contract
Created and managed a project plan; contributes to peer reviews
Supported Security Manager in preparation for FISMA attestation

Confidential, Reston, VA

PROJECT MANAGER and SENIOR SCIENTIFIC INFORMATION ANALYST

Responsibilities:

Facilitated knowledge acquisition sessions with the cross-NIH stakeholders
Reviewed and data mined thousands of NIH grants to create Congress mandated reporting categories
Analyzed and helped building biomedical research ontology using NLP-based technology
Trained and provided support to all system’s users and management
Managed two projects with total cost of 900K and the team of eight application and system analysts
Contributed to winning a contract of total value over 3M

Confidential, Gaithersburg, MD

PRODUCT MANAGER

Responsibilities:

Managed a team of 6 that built a Serious Adverse Event reporting application
Elicited and documented clients’ safety reporting requirements for multiple clinical studies
Led to the successful release of Beta version of the application based on RUP methodology
Supported initial efforts in CDISC implementation
Organized, developed and conducted online and in-class training for 22 people

Confidential, Bethesda, MD

SENIOR CLINICAL DATA MANAGER

Responsibilities:

Provided training, quality assurance and customer support to PIs and RNs
Prepared site staff and site documentation for monitors’ visits
Performed and oversaw data cleaning, query tracking, medical terms coding, AE reconciliation
Mentored a team of 8 CDMs working for oncology vaccine trials

Confidential, Lanham, MD

CLINICAL RESEARCH COORDINATOR

Responsibilities: