NAME:

Walter T. Moore III

PHONE:

984-***-****

E-MAIL:

ad0gd1@r.postjobfree.com

EDUCATION

Bachelor of Science (BS) – Virginia State University

PROFESSIONAL EXPERIENCE

Insmed, Bridgewater, NJ, USA

Clinical Data Manager - November 2021 – Present

Conduct Data Management (DM) activities for assigned studies in support of DM study lead and clinical study team. Complete assigned tasks in compliance with company processes, GCP and regulations across all study phases including but are not limited to document development and maintenance, UAT testing, reviewing data, discrepancy management, reconciliation, development and generation of data listings, tracking issues, performing database QC, and managing DM documents in the trial master file. Acts as the assistant clinical data team lead for one or more projects supporting the clinical data team lead by performing assigned tasks in study set up, data cleaning, database close-out and other associated tasks.

Provide input on Data Management (DM) related study plans including Data Management Plan (DMP), Data Validation Plan, Data Review Plan, CRF Completion Guidelines, and other study documents to ensure quality and standardization; may be responsible for updating DM documents to ensure they are up to date.

Contribute to development of initial and updated eCRF designs, including database UAT.

Assist in development of global library standards and comply with global library process.

Contribute to development and implementation of edit check specifications and work with database programmer on edit check development and validation.

Facilitate transfer of data from external vendors, which may include finalizing Data Transfer Agreement/ Specifications and verifying test data per specifications document.

Work with internal programmers to develop ad hoc SAS listings, patient profiles, and other outputs.

Run and review outputs and database study metrics; identify discrepancies to assist in data cleaning.

Participate in data reviews with clinical team to ensure accuracy, consistency, and reliability of data.

Review discrepancies in EDC system, monitor/facilitate resolution and closeout or re-query per study guidelines; note and communicate trends to clinical trial manager(s) for follow-up.

Facilitate identification and capture of Protocol Deviations, if applicable

Reconcile external data to clinical study database and perform Serious Adverse Event reconciliation.

Work with study teams to ensure study databases are locked based on pre-defined criteria and established timelines.

Ensure DM procedures and processes are adhered to in a consistent manner.

Provide high quality services through efficient and compliant processes.

PPD, Morrisville, NC, USA

Associate Clinical Data Team Lead - Aug 2020 – October 2021

Acts as the assistant clinical data team lead for one or more projects supporting the clinical data team lead by performing assigned tasks in study set up, data cleaning, database close-out and other associated tasks.

Applies relevant components of the project protocol to daily tasks with guidance.

Delivers study specific training to junior associates for assigned projects.

Coordinates data cleaning tasks and delegates to appropriate data management staff to ensure quality standards are maintained and project deliverable timelines are met.

Performs specified activities that contribute to the creation of database specifications, database build and user acceptance testing during database and edit check development.

Monitors for risks to deadlines and escalates appropriately.

Creates and maintains data management project documentation.

Participates in team and client meetings and supports the clinical data team lead with risk management on allocated projects.

Provides input into project forecasting of hours and identification of resource requirements.

Monitors study metrics and runs project-specific status reports for management.

Reviews data management deliverables for allocated projects following documented guidelines.

Produces project-specific status reports for management, PM and/or clients on a regular basis.

Syneos Health, Morrisville, NC, USA

TMF Document Specialist - Contractor, Apr 2019 – Mar 2020

Performed support tasks related to the set-up, maintenance and close out of the Trial Master File.

Participated in electronic QC and indexing of TMF documents as required.

Ensured that the clinical trial documentation was consistent with the Trial Master File specifications, applicable SOPs, ICH/GCP guidelines and other regulatory agencies requirements.

Ensured the Trial Master Files are inspection ready.

Covance, Conshohocken, PA, USA

Senior Clinical Data Coordinator - Aug 2015 – Nov 2018

Worked closely with the Clinical Data Manager to oversee data management activities.

Served as a member of the project team with primary responsibility for Clinical data review, query generation/ resolution and reconciliation activities to support the delivery of clinical data according to client quality and integrity specifications, and project timelines and productivity targets.

Development of the project Data Management Plan, including the creation of conventions and data review guidelines/ diagnostics specification; and set-up of the data management systems according to project requirements.

Served as the technical data management leader on small to moderate project with technical oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, and project timelines and budgets.

PPD, Wilmington, NC, USA

Clinical Data Manager - Sep 2012 – Aug 2015

Worked as a Lead Clinical Data Manager on one or more Phase 1-4 projects.

Provided support to another Lead Clinical Data Manager for one or more projects.

Liaised with clients and colleagues in other functional groups as required.

Fulfilled all data management cleaning activities in accordance with the Data Validation Manual (DVM) and/or client documentation.

Designated tasks appropriately within the team ensuring all work conducted was completed to the acceptable quality in accordance with global Standard Operating Procedures (SOPs) and the DVM.

Represented Clinical Data Management at internal and external meetings and presentations.

Corelab Partners, Inc., Princeton, NJ, USA

Clinical Data Coordinator - Jun 2009 – Sep 2012

Reviewed and reconciled data discrepancies within clinical databases.

Generated and managed data clarification forms for query resolution.

Proven expertise with protocol, charter language and transfer plan creation and review.

Served as data management representative for a set of assigned studies.

Liaised with CDM customers' representatives.

Attended internal and external sponsor meetings.

Participated in efficiency and quality improvement initiatives.

Created and updated data management documentation as appropriate.

Managed the data collection, review, and cleaning process for assigned studies.

Created and reviewed Data Entry Instructions and Data Review Guidelines under minimal supervision of senior staff.

Coordinated the creation/revision of forms and source documents under minimal supervision of senior staff.

In conjunction with the Oracle Clinical team, participated in the creation, design and validation of clinical databases, including but not limited to the testing of the data entry application, creation and testing of standard and study specific validation procedures under minimal supervision of senior staff.

Performed data entry as needed.

Performed quality control review of data.

Reviewed clinical data pre- and post-extraction for accuracy and completeness prior to transfer with minimal supervision of senior staff.

Coordinated multiple studies simultaneously with minimal supervision of senior staff.

Provided training to new employees under supervision of senior staff.

Performed data transfers for all applicable modes of transfer with minimal supervision of senior staff.

Actively participated in cross-functional Study Teams.

Represented the department and company professionally outwards.

Icon, North Wales, Pa, USA

Clinical Data coordinator - Contractor, Jan 2008 – Jun 2009

Issue/resolve Data Clarification Forms (DCF’s).

Resolved requests for Change Forms in Oracle Clinical.

Performed Quality Control on data entered in the Oracle Clinical database.

Updated Standard Operating Procedures (SOPs), as needed.

Communicated project status to manager and client on a weekly basis.

Worked independently on a variety of projects simultaneously.

Clearly understood and adhered to Standard Operating Procedures and working Practices.

Generated Queries and sent them to the sites for resolution.

Updated database after queries were returned from sites.

Performed Lab reconciliation and made the necessary updates.

Performed SAE reconciliation.

Reviewed eCRF's for and discrepancies.

IBM, Bethesda, MD, USA

Top Gun Class Administrator - Contractor, Feb 2007 – Dec 2007

Managed Sales training logistics.

Developed, produced and distributed program materials.

Facilitated classroom training for IBM sales personnel.

Created and updated spreadsheets (Lotus 1-2-3, MS Excel) for analysis.

Graded sales training tests/quizzes and performed other tasks that were assigned.

Touchstone Research, Gaithersburg, MD, USA

Data Manager – Contractor, Jul 2005 – Nov 2006

Development of clinical trial databases.

Tested database structures.

Prepared Data Entry and Data Management instructions.

Supervised and trained Data Entry personnel.

Trained new Data Management personnel.

Designed/annotated Case Report Forms (CRF’s).

Tested edit specifications and reviewed/resolved manual and validation discrepancies.

Issued/resolved Data Clarification Forms (DCF’s).

Resolved requests for Change Forms.

Performed Quality Control on data entered in the database.

Updated Standard Operating Procedures (SOPs), as needed.

Clinforce Inc., King of Prussia, PA, USA

Programmer Analyst – Contractor, Jan 2005 – Jul 2005

Designed and maintained coding with minimal guidance.

Designed, implemented and maintained clinical trial databases according to established standards with minimal guidance.

Created data consistency edits checks as outlined in coding and validation manuals.

Reviewed and validated manual discrepancies for completeness and accuracy.

Communicated project status to manager and client on a weekly basis.

Liaison to Clinical Monitors, Statisticians and Data Entry personnel as needed to discuss database design questions.

Worked independently on a variety of projects simultaneously.

Clearly understood and adhered to Standard Operating Procedures and working Practices.

Development of standard database consistency specifications across protocols by interacting with Clinical Project Team members.

Maintained accurate and updated database and program documentation and communicated modifications to project personnel.

Provided technical expertise in database systems.

Traveled to client site for project initiation.

Pharmanet inc., Blue Bell, PA USA

Clinical Data Manager – Jul 2001 – Dec 2004

Participated in validating ClinTrial 4.3, resolved, designed and managed modules.

Implemented and tested edit checks and derivations for multiple protocols.

Created and designed panels, items, codelists, page sections and templates for each protocol.

Tested data entry screens in ClinTrial and trained data entry staff on various protocols.

Resolved data discrepancies which were created either manually or automatically using ClinTrial Resolve module.

Created data listings for Quality Control and Clinical Data Analysts using SAS Version 8.

Created various data listing for data review and Quality Control using PLSQL in ClinTrial Retrieve module.

Performed coding tasks for ConMeds and Adverse Experiences us Costart and WhoDRL dictionary.

Imported and exported data using Manage module.

Cephalon inc., Westchester, PA, USA

Clinical Database Admin - Contractor, Mar 2001 – Jul 2001

Participated in writing of ClinTrial 4.1Oracle 7.3 validation plan and Testing.

Implemented and tested edit checks and derivations for multiple protocols.

Developed and designed panels, items, codelists and templates for each protocol.

Tested data entry screens in ClinTrial.

Resolved data discrepancies which were created either manually or automatically in ClinTrial Resolve module.

Created data listings for SAS programmers and interacted with them to resolve data discrepancies.

Created various data listing for data review and QC using PLSQL in ClinTrial Retrieve module.

Created Data Discrepancy Forms which were sent to various sites for resolution.

Performed coding tasks for Conmeds and Adverse Experiences us Costart and WhoDRL dictionary.

PROFESSIONAL Development

Training while employed at PPD is available upon request

Languages

Native Tongue: English

Therapeutic Experience and Expertise

Cardiovascular: Hypertension, Hyperlipidemia

Central Nervous System: Bipolar Disorder, Acute Schizophrenia

Infectious Diseases: Human Immunodeficiency Virus (HIV), Hepatitis C

Oncology: Breast Cancer, Lung Cancer, Metastatic Colorectal Cancer

Respiratory: Asthma

Clinical trial Experience

Oncology: A Phase Ib/II Study of an Antineoplastic or an Antineoplastic with an Antineoplastic versus Abiraterone an Antineoplastic in Patients with Castration-Resistant Prostate Cancer Previously Treated with XXX-Based Chemotherapy

Oncology: A Randomized Phase III Multi-Center Double-Blind Placebo-Controlled Study Evaluating the Efficacy and Safety of a Monoclonal Antibody in Combination with a Chemotherapy Agent in Patients with c-MET High Incurable Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) Who Have Failed Standard Therapy for Advanced or Metastatic Disease

Oncology: A Randomized Double-Blind Phase II Trial of a Mitotic Inhibitor + a Chemotherapy Agent + Another Chemotherapy Agent with or without a Monoclonal Antibody in Patients with Previously Untreated Advanced-Stage Non-Small Cell Lung Cancer

Oncology: A Phase II Randomized Placebo-Controlled Double-Blind Study of a Monoclonal Antibody Combined with Another Monoclonal Antibody Plus a Chemotherapy Agent Versus A Monoclonal Antibody and a Chemotherapy Agent Alone as First-Line Treatment in Patients with Metastatic Colorectal Cancer (mCRC)

Gastroenterology: A Phase 2a, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of XXX in the Treatment of Patients with Diarrhea-predominant Irritable Bowel Syndrome (IBS-D) Irritable Bowel Syndrome:

Computer Experience

MS Office (Word, Excel, PowerPoint)

Windows OS

EDC (Medidata Rave, JReview, InForm, OmniComm TrialMaster)

Veeva Vault

CERTIFICATES/TRAINING

Certificate PLSQL Programming, Oracle Phase Forward, Redwood Shores, CA, USA, 1999.

Certificate 4.1 to 4.3 Bridge Training, Oracle Phase Forward, Redwood Shores, CA, USA, 2004.

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