Professional Experience

Confidential, Raleigh, NC

Owner/Data Manager

• Provides Clinical Research services to prospective clients

Confidential, Durham, NC

Senior Lead Clinical Data Manager

Responsibilities:

• Managed  confidential Projects/Programs
• Confidential lead for internal/client team meetings and communication
• Provided Metric reports for internal/external project teams
• Provided staffing projections for Confidential activities for studies (including coding)
• Implemented process or system improvements for global implementation
• Ownership for project deliverables within Data Management and Project Programming scope of services
• Discussed roadblocks with PM & principal for completing study objectives in a timely manner
• Reviewed project budgets and staffing projections for data operation activities
• Provided training of Confidential staff on project specific processes
• Supported Business Development activities as needed
• Clinical Data and Query Review:
• Created Data Review Plan for studies
• Developed standards for Data Review Plans
• Created listings using ad hoc query tools
• Oversaw the issuing of queries and review query responses with the highest level of quality based upon the Data Review Plan
• Oversaw System Development and modifications:
• Drafted the CRF design, edit check specification and Confidential listings
• Facilitated clinical team review of system (Online Screen Review, Edit Check Review, and Data Review Plan review, etc.)
• Consolidated comments from internal/sponsor for discussion and approval
• Ensured all non - Confidential activities related to database development are completed in a timely manner
• Ensured all database modifications are communicated with team and implemented effectively
• Validation Creation
• Oversaw the entry of data in the Development or Quality Control systems used for validation.
• Performed the validation of CRF system (CRF content & edit checks), Reports using EDC Reporting and/or J-Review, and associated change control.
• Provided feedback to the Programmers to improve the deliverables.
• Created and Maintained Documentation for studies/programs/departmental standards:
• DMP (along with supporting Confidential documents)
• CRF Completion guidelines
• Data Entry guidelines
• Trial Design Document
• Edit specifications
• Reconciliation guidelines
• Report specifications
• Project Specific SOPs/WPs (as directed by PM)

Confidential

Senior Clinical Data Manager

Responsibilities:

• Led and Locked 27 (Phase I) databases for a primary company client
• Planned and managed all Clinical Data Management (CDM) activities on assigned project(s), complexity, phase (set-up, maintenance, close-out) and timelines
• Created and maintained project documentation file(s)
• Designed content of the Case Report Forms (CRF) according to the Protocol
• Developed all components of the Data Management Plan (DMP) including Data Validation Specifications, study-specific Data Entry and Medical Coding Guidelines, Electronic File Transmission Specifications
• Collaborated with Clinical Programmer to facilitate database set-up and testing, including data entry screens and programmed edit checks, development and testing of data review listings, development and testing of export programs for SAS® delivery database and the development and testing of programs to import and integrate external data from third-party providers
• Served as Data Management liaison to project teams assisting in problem-solving and strategizing data processing issues
• Independently monitored receipt and processing of clinical data from start-up through database lock prioritizing work to meet project timelines and providing feedback to monitors on backlog (CRF and queries)
• Performed data review of automated and manual checks and issue queries as required to resolve data discrepancies
• Reviewed reconciliation listings of electronic data transmissions and issue queries as required to address data discrepancies
• Reviewed and performed coding of adverse events, medications, and medical history as applicable to ensure consistency and accuracy of preferred terms and classifications with similar verbatim terms; issue queries for non-specific/ambiguous terms
• Provided feedback, as required, to coders
• Performed and reviewed quality review audits clearly documenting findings to facilitate resolution
• Coordinated and performed database-locking activities, including final coding review and sign-off, determining that all data is received and processed, that all queries are resolved and no further discrepancies exist, final Serious Adverse Event (SAE) reconciliation and sign-off, and completion of all QC activities including necessary updates and documentation of quality review processes in the Quality Evaluation Summary
• Coordinated data archival activities with Data Management staff to ensure that documentation is complete

Confidential, Durham, NC

Clinical Data Manager

Responsibilities:

• Served as primary Kendle contact with Sponsors and represents Clinical Data Management (CDM) on project teams
• Managed project timelines, deliverables, and overall quality
• Created / maintained CDM project budgets and essential CDM documents
• Approved the building, testing and validation of clinical databases
• Coordinated receipt and processing of information for projects (e.g., coding dictionaries) as well as electronic data received from specialty groups (e.g., lab data, e-diary data)
• Served as Biometrics Project Leader responsible for CDM, Programming and Statistical services
• Participated in training of CDM associates
• Supported new business development activities as needed

Confidential, Cary, NC

Clinical Data Analyst

Responsibilities:

• Served as point person for day-to-day project activities as back-up to Lead Data Manager
• Performed data review and query generation
• Tracked study progress, distributed reports and generated/compiled data management statistics as relevant to the project
• Assisted in coordinating the work of Associate Data Analysts assigned to the project
• Defined and tested edit checks
• Developed data entry guidelines
• Assisted in CRF development and design
• Interacted closely with Clinical Research Associates (CRA) in dealing with project needs as necessary

Confidential, Research Triangle Park, NC

Clinical Data Scientist

Responsibilities:

• Served as lead Clinical Data Manager and back-up Lead Data Manager for Phase II-IV GSK clinical studies
• Conducted study database set-up and related documentation
• Participated in and conducted study meetings as necessary
• Conducted all data cleaning, including query generation, review of SAS® listings, manual data cleaning, and quality assurance (QA) audits
• Ensured that study timelines were met and databases locked on schedule and/or ahead of schedule

Confidential, Research Triangle Park, NC

Clinical Data Specialist/Clinical Data Associate II

Responsibilities:

• Conducted both manual and electronic data cleaning per study-specific guidelines utilizing Clintrial 3.3 and Oracle Clinical 4.5
• Wrote and executed SQL statements as related to electronic data cleaning
• Executed database validation
• Performed quality control (QC) auditing activities including identification and documentation of findings, updating, and responding to QC findings
• Composed and resolved Data Clarification Forms (DCF)
• Generated and reviewed exception reports, and resolved related issues
• Assisted Project Manager in daily study activities and kept abreast of project deadlines and helped ensure that team goals were met

Confidential, Durham, NC

Data Coordinator/Manager, Oncology

Responsibilities:

• Served as Data Manager for Confidential lymphoma and transplant studies
• Reviewed protocol drafts to ensure clear and consistent definitions of study objectives, eligibility criteria, primary analysis endpoints, evaluation criteria (toxicity and response definitions) and guidelines for removal of patients from protocol therapy
• Reviewed Institutional Review Board (IRB) and Informed Consent (IC) criteria
• Reviewed source documentation to ensure that submitted data met protocol specifications and criteria
• Queried for delinquent/missing/errant data
• Designed study specific CRFs
• Interacted with Study Chairs, Statisticians, and CRAs to ensure that protocol therapy was being carried out appropriately
• Attended Confidential Group Meetings to consult/work with world-renowned oncology researchers
• Served as registrar in randomizing and assigning subjects to Confidential studies
• Promoted from Data Technician to Data Coordinator/Manager within six months