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 CLINICAL PROJECT MANAGER

ANNA Miller

Anna.Miller@hotmail.com

PROFESSIONAL SUMMARY

·         Possess extensive experience in Pharmaceutical Clinical Trials/Data Management. Specific experience as a Project Data Management in all Phase of Clinical Trials; Electronic Data Capture, Phase Forward, InForm 4.6 and Oracle Clinical.

·         Overseeing outsourced data management activities to ensure that the clinical team and FSP expectations are understood and matrix are met. Knowledgeable of database design, QA auditing, DVS creation and review, UAT, External Vendor DTS and I-Review Listing.

·         Validation procedure testing, queries generation and resolution. Knowledgeable of FDA Regulation 21CFR Part II and Good Clinical Practice (GCP). Work effectively in a team environment as well as independently.

·         Experience in working with CDISC and SDTM standards; reviewing and resolving PK/PD discrepancies in (Phase 1) studies.

TECHNICAL SUMMARY

·         Phase Forward InForm system, Discoverer Reporting tool, Integrated Review, Oracle Clinical, OC/RDC System, Electronic Data Management System, AERS, Trial Access Online, SMT Reporting System, Data Management and Discrepancies system, EDC System, MS Office Applications, STAR (I-Review)

PROFESSIONAL EXPERIENCE

DolCas Biotech LLC, Chester, NJ

Sr. Project Data Manager (PDM)

Mar 2007 – Till date

·         Working as the lead Data Manager and closely with client CQC Mangers, Statisticians, Programmers and other staff to develop CRF’s for Oracle RDC to ensure the information required for statistical analysis in Woman Health and Respiratory Studies are present.

·         Responsible for managing data management activities from start-up through database lock and lead others CQC’s in data review and cleaning.

·         Ensuring accuracy and integrity of database with consistent with data management procedures.

·         Working collaborative with Client CQC managers to meet studies timelines, oversee discrepancy management, query resolution and data cleaning by CQC’s.

·         Communicate effectively with Clients and internal management teams to articulate study status, needs, concerns, data handling, and discrepancy management.

·         Performed selected candidates interview for new CQC position, provide idea how to improve processes, work independently, as well as, closely with other management team leaders to meet goals and timelines.

Enhance Biotech, Inc, New York, NY

Project Data Manger (PDM) Frontier

Nov 2004 – Feb 2007

·         Worked closely with CRA Managers/Project Manager/Statisticians and other staff as appropriate to develop CRF’s to ensure the information required for statistical analysis is present.

·         Responsible for managing data management activities from start-up through database lock, data management point of contact for studies outsourced to CRO/FSP.

·         Ensured accuracy and integrity of database, ensured consistency of data management procedures, assisted in selection process of contract research vendors, assisted and collaborated with contract vendors, provided some direction and guidance.

·         Oversee discrepancy management, queried resolution and data cleaning by CRO/FSP for assigned program.

·         Communicated effectively with Vendors/FSP and project teams to articulate status, needs, concerns and goals, initiated efforts to standardize data collection, data handling, and discrepancy management, and ways to improve processes, worked independently, as well as, closely with other team leaders to meet goals and timelines.

Amazon Biotech, Inc, New York, NY

Clinical data manager

Apr 2002 – Oct 2004

·         Performed Oracle Clinical Data Management Discrepancy activities such as: reviewed multivariate and Univeriate system edit; created manual queries from database listing review.

·         Ran batch validation; escalate TMS discrepancies to appropriate status. Update Database with queries response from sites, work closely with site managers to resolve site issues and ensured protocol guidelines are being followed.

·         Review DCF’s and updated database with site response through OC Data Clarification Maintenance System then release the DCF to verification queue. Ensured data management and clinical timelines were met.

Generation Biotech Llc, Lawrence Township, NJ

Associate Data Manager

Jul 2000 – Mar 2002

·         Performed Data listing for ongoing eDC studies to ensure that the databases reflected the correct data captured on the Case Report Forms.

·         Performed line data reviewed, reviewed actionable discrepancies in Remote Data Capture system (Trial Access Online) for inconsistency entries by sites; Participated and Collaborated with Clinical team in study start up for eDC Studies (Trial Access Online).

·         Conveyed sites data entries trend to site manager, provided assistance to sites coordinators with data entry issues and eDC system updates to ensure clean data are transmitted.

·         Prepared Data Matrix Reports (resolved/unresolved and outstanding queries) to clinical team & monitors Ensured that all study related communications are communicated effectively to project team to promote productivity.

·         Performed discrepancy management activities as needed based on output generated from batch validation specifications.

EDUCATION

MS in Science

Montclair State University

Montclair, NJ

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