Management Data
Resume:
Shandra R. Bryant
West Orange, NJ 07052
973-***-****-Home
973-***-**** - Mobile
*********@***.***
Summary
. Hard working individual that has approximately 9 years Clinical SAS
programming as well as Clinical Data Management experience
. Has worked with various versions of SAS including v.6, v.8, v.9, v
9.1
. Onsite liaison between clinical, IT, data management (including data
analysts and data coordinators), statistics and upper management
. Recognized subject matter expert in Pharmaceutical Clinical Data
Management processes, HL7 process in a clinical/hospital setting,
Clinical data modeling, standards and related information solutions
. Familiar with annotating a casebooks in PDF and the development of
Project Data Management plans
. Knowledge and hands on experience of CDISC standards this includes
observations and variables, datasets and domains
. Knowledge and hands on experience in HL7/ Clinical setting/ hospital
environment
. Program SAS datasets and/or ad hoc programs to be tested and validated
as it pertains to data modeling within the clinical data management
environment
. Demonstrated excellence and thought leadership in data modeling as a
discipline from standard metadata for dataset contents and attributes
to using CDISC domain models in regulatory submissions (Dataset-
Metadata)
. Implementing processes for eCTD (Electronic Common Technical
Document); To be utilized for SDTM, to support submissions to the FDA
and this includes but not limited to the relationship from domain
models to data analysis datasets
. Implement data management systems/EMR systems within clinical/hospital
setting (main use for clinical and/or electronic medical records)
. System site integration
. Train and mentor clinical staff and data management/data entry
personnel on current CDMS (Clinical Data Management System) both
onsite and/or at designated client location
. Extensive knowledge and experience with clients/teams in technical and
solutions delivery experience
. Experience in system backups, upgrades and documentation which
includes and is not limited too data migration
. SME of EDC Vendor Selection (pricing and contract negotiation)
. SME of CRO/Site selection process (pricing and contract negotiation)
. EDC & IVRS from testing to production
. ICH, GCP, GMP Guidelines
. 21 Part CFR Part 11 Compliance; ISO 9001, CDISC standardization
. Development of Case Report Forms
. People and technical solution delivery experience as well as knowledge
and capabilities on a wide range of tools either homegrown and/or
purchased data management databases and/or tools.
. Development of database design, database structures, testing and
validation
. Program SAS datasets and/or ad hoc programs to be tested and validated
. Locked more than 30 databases a year
. Therapeutic areas: HIV,CNS, Cardiovascular, Dermatology, Dental,
Ophthalmology, Appetite suppression/weight loss, GI (Gastro
Intestinal) and Oncology
Databases/Office programs
Microsoft Office 95, Microsoft Office 97, Microsoft Office 00, XP, SAS
6.1.2, SAS 8.1, SAS 9.1, Oracle Clinical 4.1, 4.3; Siebel Clinical, Oracle
Business Intelligence, PL/SQL, Oracle 8i, Oracle 9i, Clinplus 6.1.2,
Clinplus 8.1.2, SMS, Clinaccess, ClinTrace, ARGUS, ARISg, Clintrial 3.1,
Clintrial 4.3, DataLabs, I-Review, InForm, eTMF, Power2Learn, Eaccess,
Eclipse, E-Trials, eRT, DataFax, RAVE (Medidata), CCFE (Common Census),
QuarkXpress and Blaise
Medical coding dictionaries
WHODD, MeDdra 5.0, 6.0,7.0, 9.0, 10 & 11.0 & COSTART
Other Skills
SDLC (System Development Life Cycle), 21 CRF part 11 guidelines/compliance
within clinical trials and clinical trials database systems; Team lead in
the implementation of study data tabulation and implementation guide (s);
Recognized subject matter expert in Pharmaceutical Clinical Data Management
processes, within a hospital/ clinical setting; Clinical data modeling,
standards and related information solutions; knowledge and capabilities on
a wide range of tools. Query generation and resolution; Excellent
Oral/Written communication skills; knowledge of ICH, FDA and GCP
guidelines; edit check specifications/documents/programming; data
entry/review guidelines, Level 1 corrections document(s) and case report
form development and data modeling documentation
Work Experience
Cardiovascular Research Foundation - October 1, 2009 - December 31, 2009
(New York, NY) (3month contract)
Manager of Clinical Data Management
2 Direct Reports (Clinical Data Coordinators)
. Develop and maintain Project Data Management Plan
. Responsible for setting all timelines per project
. Implementing processes to support data management/ clinical personnel
. Perform data management activities related to project
. Write and implement Edit Checks
. Manual Data Review document creation for data entry personnel
. Work closely with other department members on the projects
(Programming, Stats, Coding Group and Clinical (Sponsor and In house
members)
. Problem solved all issues with Sponsor, Sites and anything project
related
. Review data listings for quality, content, format and output
. SOP review and creation of new SOPs as needed
. Developing a process for QMS (Query Management Systems)
WYETH Inc. January 2009 - July 1, 2009 Madison, NJ (Wyeth was
acquired by Pfizer effective date January 25, 2009) (CONTRACT)
Head of Data Management
(4 Direct reports - 3 CDAs, 1 CDC)
. Develop and maintain Project Data Management Plan
. Responsible for setting all timelines per project
. Recognized subject matter expert in Pharmaceutical Clinical Data
Management processes, Clinical data modeling, standards and related
information solutions
. SME of EDC Vendor Selection
. Manual Data Review document creation for data entry personnel
. Create and maintain all study DM documents and files
. Implementing processes to support data management/ clinical personnel
. Perform data management activities related to project
. Write and implement Edit Checks
. Implement new data management systems and train clinical/data
management personnel
. Responsible for the entire UAT development process
. SAE Reconciliation; LAB Data Reconciliation
. System site integration
. MedDRA and WHODRUG Coding (MedDra versions 7.1 - 9.0)
. Main point of contact for Clinical Research Associates
. Monitors the progress of all data management activities for projects
to ensure that projects timelines are met
. Monitors the quality of all Data Management activities for projects
(Data Listings, QC Audits and Coding)
. Perform reconciliation of Serious Adverse Events and as defined on a
project by project basis
. Perform reconciliation of Laboratory and other ancillary data
. Generate Data Clarification Forms (DCFs) and communicate with CRAs and
study sites to obtain resolutions in a timely manner
. Write study-specific validation rules to assist in data cleaning
process
. Responsible for training and mentoring of clinical, data management
staff; either onsite and/or off site locations
. Maintain data entry and DCF logs for assigned project
. Correct data entry discrepancies and perform necessary database
updates per obvious corrections as defined in the data management plan
and per DCF resolutions
. Work closely with other department members on the projects
(Programming, Stats, Coding Group and Clinical (Sponsor and In house
members)
. Problem solved all issues with Sponsor, Sites and anything project
related
. Review data listings for quality, content, format and output
. Perform all Clinical Data Coordinator duties for assigned projects
. Data Management contact with Sponsor managing client expectations,
noting and responding to out-of-scope work
. Problem solve all issues with Sponsor, Sites and any issues project
related
. Manage and track data cleaning process
. Perform hands-on data management tasks as needed, including edit check
programming, and database corrections
MAXISIT, Inc. February 2008 - October 2008 Edison, NJ (PERMANENT)
Clinical Data Manager, FSP (Functional Services Provider for Pharmaceutical
Clients)
(5 Direct reports - 2 CDAs, 2 SAS Programmers, 1 CDC)
. Develop and maintain Project Data Management Plan
. Recognized subject matter expert in Pharmaceutical Clinical Data
Management processes, Clinical data modeling, standards and related
information solutions
. Manual Data Review document creation for data entry personnel
. Create and maintain all study DM documents and files
. Implementing processes to support eCTD (Compiles both the Project Data
Management Plan and the Database specifications document) as it
relates to SDTM
. System site integration
. Perform data management activities related to project
. Implement new HL7/data management systems both onsite and off site
. SME of EDC Vendor Selection
. SME of CRO/Site selection process
. Write and implement Edit Checks
. Responsible for the entire UAT development process and this includes
but is not limited too EDC and IVRS system
. SAE Reconciliation; LAB Data Reconciliation
. MedDRA and WHODRUG Coding
. Main point of contact for Clinical Research Associates
. Monitors the progress of all data management activities for projects
to ensure that projects timelines are met
. Monitors the quality of all Data Management activities for projects
(Data Listings, QC Audits and Coding)
. Perform reconciliation of Serious Adverse Events
. Perform reconciliation of Laboratory and other ancillary data
. Generate Data Clarification Forms (DCFs) and communicate with CRA**s
and study sites to obtain resolution
. Write study-specific validation rules to assist in data cleaning
process
. Responsible for training and mentoring of clinical, data management
staff; either onsite and/or off site locations
. Maintain data entry and DCF logs for assigned project
. Correct data entry discrepancies and perform necessary database
updates per obvious corrections as defined in the data management plan
and per DCF resolutions
. Work closely with other department members on the projects
(Programming, Stats, Coding Group and Clinical (Sponsor and In house
members))
. Problem solved all issues with Sponsor, Sites and anything project
related
. Review data listings for quality, content, format and output
. Perform all Clinical Data Coordinator duties for assigned projects
. Data Management contact with Sponsor managing client expectations,
noting and responding to out-of-scope work
. Problem Solve all issues with Sponsor, Sites and anything project
related
. Manage and track data cleaning process
. Perform hands-on data management tasks as needed, including edit check
programming, and database corrections
MERCK Inc. June 2007- December 2007 Rahway, NJ
(CONTRACT)
CTMS Data Specialist - (Citrix Metaframe, Oracle Clinical)
(Four direct reports; 2 Data Specialist, Data Technicians)
. Responsible for the implementation and development of the entire
clinical trial development process
. Ongoing management of clinical trial data, Phases I to IV
. SME of site selection
. Responsible for maintaining data from portable (laptop) to host
(Citrix Server Metaframe)
. Recognized subject matter expert in Pharmaceutical Clinical Data
Management processes, Clinical data modeling, standards and related
information solutions
. Responsible for but not limited to: Addressing inefficiencies inherent
in the operational side of research, including site performance
tracking and management, patient recruitment, team collaboration,
resource management, supply chain management, and regulatory document
management
. Tracking subject enrollment statistics, protocol amendments, site
payments and clinical inventory
. Implement data management process for CDMS and provide all
documentation limited to the new system
. Implementing processes to support eCTD, SDTM
. Performing Data Warehousing duties (EDC-CTMS)
. System site integration
Novartis Pharmaceuticals April 2006- March 2007 East Hanover, NJ
(CONTRACT)
Senior Clinical Data Manager - Oncology Team for the U.S. - AMN - (Tasigna)
(6 direct reports; 4 Assistant Data Managers, 2 Data Managers)
. Provide timely and professional ongoing management of clinical trial
data, Phases I to IV, by preparing validation plans and chairing
validation meetings.
. Prepare material for and presenting at Investigator meetings, identify
errors and inconsistencies in CRF data and ensure their resolution.
. Performing serious adverse event and external data reconciliation e.g.
lab data, in order that databases can be declared clean and locked
according to strict quality standards.
. SME EDC Vendor selection process (Currently using Clintrial 4.3 but
changing to Oracle Clinical January 2009)
. Recognized subject matter expert in Pharmaceutical Clinical Data
Management processes, Clinical data modeling, standards and related
information solutions
. Support eCTD, SDTM processes and make changes to reflect CDISC
standards (Includes Project Data Management Plan and Database
Specifications Document)
. In addition, to represent the DM function in International Clinical
teams, to define project as well as trial level data management
strategy and manage clinical trials or projects
The Medicines Company December 2004 - June 2005 Parsippany, NJ
(CONTRACT)
Clinical Data Manager - The Acuity Team (Angiomax Trial)
(4 direct reports; 2 Clinical Monitors, 1 SAS Programmer and 1 Medical
Coder)
. Oversees clinical data management for 53 sites in the US and Canada;
Liaison for Data Management/ Statistics/ Clinical
. Data review, perform discrepancy management activities as needed,
based on output generated from the batch validation specifications
(SAS v.8.1)
. SME site selection process
. System site integration
. Data entry guidelines; query monitoring system, resulting from
returned data report forms/listing reviews/coding feedback/etc.
. Serve as primary contact person for Clinical Data Management related
study issues (i.e., study closeouts, accountability spreadsheets to
ensure accuracy of sponsor product) expense reporting, staff and
timesheets issues and approvals.
Pfizer June 2004 -December 2004
Morris Plains, NJ (CONTRACT)
Records Management Associate-Worldwide Regulatory Operations - Records
Management
(4 direct reports; 4 Records Associates)
. Training and mentoring active file members and any new employees
. Developed new processes and SOP's for the active file department
. System site integration
. EDC Vendor selection process ( Decided to create own database for
budgeting reasons)
. Recognized subject matter expert in Pharmaceutical Clinical Data
Management processes, Regulatory processes as it relates to Clinical
data modeling, standards and related information solutions
. Created, developed and tested new databases for the members of the
active file department
. Resolved data correction forms and any other forms of data
discrepancies (using SAS v.8 edit check programming)
Covance March 2004 - June 2004 Princeton, NJ
(CONTRACT)
Clinical Data Manager - Clinical Data Management
. Reviewed and audited CRF and data listings to ensure accuracy
. SME EDC Vendor Selection process (In 2004 used homegrown system
Sherlock; moved to Oracle Clinical with Inform 2006)
. Validating SAS datasets; edit check programming; query generation and
resolution
Pfizer October 2003 - December 2003 Morris Plains, NJ
(CONTRACT)
Sr. Safety Data Analyst - Consumer Health
(4 Direct Reports; 4 Data Analysts)
. Auditing databases throughout the company to ensure FDA
compliance/standards
. Ensure accuracy and accountability of all SAEs and AE reconciliation
. Performing discrepancy management activities as needed (using SAS v.6
TKL Research Inc. March 2001- June 2003 Paramus, NJ
(PERMANENT)
Clinical Data Manager/Sr. Clinical Data Coordinator/ Clinical SAS
Programmer
(3 Direct Reports; 2 Data Entry Technicians & 1 SAS Programmer)
. Training and mentor all data management staff
. Executing data management processes required from beginning (database
creation) to lock study database
. Recognized subject matter expert in Pharmaceutical Clinical Data
Management processes, Clinical data modeling, standards and related
information solutions
. Coordinate project personnel involved in all data management
activities/objectives
. Responsible for CRF development, process flow and query generation /
resolution
. Liaison for study team members/functional groups on all levels,
domestic and international, on technical requirements for database
development and quality
. Testing/Validation of all databases prior to data entry
. Track subject enrollment and status
. Liaison for clinical trial document management; development of
annotated CRF
. Project data management plan and edit check specifications data entry
guidelines, Level 1 corrections document(s); Organize and archive
regulatory documents; coordinate and track the shipments of supplies
to investigational sites
. Review hard copy CRF and protocols to ensure completeness and clinical
accuracy of information specify appropriate validation specifications
for the assigned project/study
. Data retrieval and analysis; maintain study files and follow-up with
sites to ensure adherence to study timelines;
. Responsible for creation of programs in SAS for the generation of QA
listings/ data review; Perform discrepancy management activities as
needed, based on output generated from the batch validation
specifications
. Test and manage inventory of study equipment; Compilation - including
primary author's role - of Data Handling Plan document for assigned
study and continuing responsibility for document updates throughout
the life of the study
. Perform needed maintenance to the database and the query monitoring
system, resulting from returned DRFs/listing reviews/coding
feedback/etc.
. Serve as liaison for customers as well as (Clinical, Statistics, Data
Entry & Data Management.) for Data Management related study issues
(i.e., study closeouts, accountability spreadsheets to ensure accuracy
of sponsor product) expense reporting, staff and timesheets issues and
approvals.
Aetna US Healthcare December 1998 - February 2001 Fairfield, NJ
(PERMANENT)
Senior Rating Analyst- Small Groups Department
(2 Direct Reports; 2 Rating Analysts)
. Review incoming requests for Group Insurance (GI) product quotes
. Screen for missing information and consult with broker or employer to
obtain data in order to take appropriate action
. Assist GI Account Executive (AE) by copying and submitting requests
for quotes to appropriate for underwriting or rate calculation unit
. Assemble sales proposals, packages, marketing and training material
. Distribute packages, proposals, etc. according to AE's instruction. In
absence of the Group Insurance Account Executive, will be responsible
for reviewing incoming faxes, emails, daily mail and telephone calls,
prioritizing and responding to each as required
. Assist the Account Executive in assembly of new business paperwork,
broker commission submission, commission exceptions, etc., diary and
follow up
. Must continually retain contact with the Group Insurance AE, allowing
for urgent matters to be resolved immediately
. Plan, arrange and prepare for meetings, seminars and appointments for
Account Executive, and coordinate logistics and catering as required
. Provide Group Insurance Account Executive with administrative support
surrounding monthly sales reports and report entries
. Responsible for supporting our National Account field sales force by
developing strategically oriented proposal responses. This entails
qualifying and coordinating responses to requests for proposals by
assisting in the development of the sales strategy, interpreting and
applying underwriting policy, preparation of the financial response,
preparing topic specific questionnaire responses and delivering a
timely and complete proposal response
. Rating Analysts are responsible for developing and maintaining
technical knowledge and pricing methodology of all products and
services
. Additional responsibilities include organizing and assisting in
customer focused sales presentations
United States Army January 1996- November 1998 Fort
Totten, NY
Sr. Information Systems Operator Analyst - Information Technology- 77Th
Regional Support Command
(One Direct Report; One Technical Analyst)
. Operates and performs unit maintenance on multifunctional/multi-user
information processing systems and peripheral equipment
. Transfers data between information processing equipment and systems;
isolates malfunctions; assists in design and testing of computer
programs; drafts technical documentation
. Configures equipment to meet operational needs; performs senior
operator an systems administrator duties
. Compiles production statistics; conducts training; writes, tests, and
modifies computer programs; drafts operating manuals; troubleshoots
software (used SAS v3)
United States Army September 1995 - September 1996 Pensacola, FL
(One weekend a month two weeks a year)
Combat Documentation/Production Specialist- 361st Press Camp Headquarters
. Operates and performs maintenance on motion, still, and studio
television cameras and electronic and film-based processing
. Editing, audio and printing darkroom equipment; prepares captions for
documentation images
. Operates and performs preventive maintenance on vehicles and power
generators.
Education
Bachelor's Degree in Information Technology Thomas Edison State
College Trenton, New Jersey
Anticipated graduation date: Mid 2010 (completed a total of 87 credits)
Associate's Degree in Visual Communications Defense Photography
School Pensacola, Florida
August 1994 -August 1996 (completed 60 credits)
References available upon request[pic]
Contact this candidate