SUMMARY

• Total 7+ years of experience in Clinical Data Management (CDM) and software validation as a Clinical Data Manager.
• Comprehensive knowledge of Clinical Research, Drug Development Process and Regulatory Affairs.
• Worked on variety of clinical trials for both drugs and medical devices.
• Working knowledge of GMP, GCP, GLP, ICH Guidelines, also familiar with CDISC, CDASH and SDTM.
• Proficient in working on all tasks involved in clinical Data Management and Medical device software validation.
• Expertise in developing Case Report Forms (CRFs) along with Annotations as per clinical protocol.
• Performed software validation along with creation of supporting documents, test scripts and User Acceptance Testing (UAT).
• Oversee performance ofSAEreconciliation.
• Performed data cleaning and query management.
• Actively worked on data cleaning, query management, external vendor lab data reconciliation.
• Hands on experience in SAE reconciliation, using MedDRA and WHO drug dictionary.
• Provided assistance with interim analysis and database unlock/lock.
• Served as single point of contact (SPOC) for third party vendors.
• Coordinated User Acceptance Testing (UAT) to ensure requirements are met; updated user manuals, standard operating procedures, and technical documentation (business rules, data dictionaries and among others).
• Wrote configuration management processes to ensure contractors could be paid for changes toSOW,
• Modification of the database according to sponsor/CROspecifications.
• Strong knowledge ofDMPoperations, audience data strategy, and overallDMPmanagement
• Ensure study database is appropriately cleaned in accordance with agreed uponDMP
• Developed training material and provide training to new employee and mentor them.
• Working experience in Quality Control of Documentation including RCA, CAPA forCRFand study documents.
• Excellent management skills including handling project timelines, strong communication, interpersonal skills and ready to take initiative.

PROFESSIONAL EXPERIENCE

Confidential, Conshohocken, PA

Sr. Data Manager

Responsibilities:

• Develop (Global) Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data
• Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts.
• Develop study conventions and plans such as theDMPand CCGs to deliver accurate, timely, consistent, and quality data
• Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics
• Coordinate and participate in the development of the clinical data model and/or database design and annotate theCRF(eCRF) according to these specifications
• Review data acquisition conventions and data review guidelines/diagnostic specifications consistent with the clinical data model, statistical analysis plans, andZ(eCRF) completion/monitoring conventions
• Coordinate the development and testing of data management system edit/data validation checks (diagnostics) and special listings/procedures used as tools for the data review and discrepancy management activities
• Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set - up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality
• Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.
• Responsible for patient demographic data change request for external pharmaceutical clients and CRO's.
• Assist with goal creation and performance review assessment for data review project staff
• Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.
• File and maintain the AE/SAEReporting Source documents.
• Review literature and research technologies/procedures for improving global data management practices
• Perform other duties as assigned by management

Confidential, Gaithersburg, MD

Sr.Clinical Data Manager

Responsibilities:

• Performs tasks related to all aspects of the clinical trial data management process from study start up to database lock for both paper-based and EDC trials
• Represents Data Management on Clinical Trial teams
• DesignsCRFand clinical database structures for data acquisition and data entry
• Identifies and resolves dataflowprocess issues in collaboration with the project team
• Defines data handling conventions, edit checks, quality acceptance and auditing criteria for electronic data as well as procedures for handling exceptions for violations to the standard metadata and identifies and requests additions to standard metadata
• Creates standard and ad hoc reports to efficiently identify outstanding queries, query types per site, etc.
• Data entry oversight, cleaning, documentation and reconciliation of serious adverse events (SAE) with the drug safety database according to the respective SOPs and to ensure compliance with FDA guidelines
• Resolves discrepancies and unresolved issues that arise during data entry
• Assesses and reports on data outlier values.
• Provide CDM input to study protocols and Study Specification Worksheets (SSW) forCROproposal requests; provide input onCROselection
• Evangelize best practices and nuances ofDMPoperations and data-driven campaign executions
• Identifies SAEs and works with Safety to ensure reporting
• Identifies areas of manual data review where electronic checks are not effective
• Uses available tools, systems and processes in support of the coding of medical terms
• Communicates with vendors to define required file format and content specifications for electronic files and establishes schedule and process for data transfers
• Participates in the identification, review and evaluation of new data management technologies
• Follows up on query responses and errors identified in data cleaning
• Drafts new Data Management Plans based on templates and Plans for similar protocol types
• Liaises with third-party vendors such as central laboratories in a project-manager capacity
• Monitors timelines to ensure data management of Stand Operating Procedures (SOPs) related to data management activities

Confidential, Raleigh, NC

Lead Clinical Data Manager

Responsibilities:

• Mentors, motivates and supervises data management staff
• Sign time off request and time-sheets
• Performs performance reviews coaching, and disciplinary actions along with Group Manager/Data Management Team Leaders
• Develops and implements study-specific Clinical Data Management Plans which meet sponsor specifications
• Functions as a study Lead Data Manager on small to medium size studies or co-lead on clinical data management programs
• Provides project specific training and updates study team training records
• Develops database specifications (e. g., annotates Case Report Forms) and specifications for external data sources
• Writes user test plans for data entry screen, electronic edit checks and medical coding
• Performs User Testing and analysis of electronic edit checks and medical coding
• Writes functional specifications for electronic edit checks, quality control listings and non-standard clinical study data reports
• Ensures that all clinical study data captured and maintained by external vendors are incorporated into the study database in collaboration with Clinical Programming. Identifies and corrects discrepancies between the clinical database and data merged into the database from external sources
• Performs medical data encoding as specified in study-specific Coding Plans and the study protocol
• Uses strong working knowledge of clinical database design and structure to facilitate data review activities and create corrective action plans
• Runs, reviews and distributes reports to internal study team and sponsors
• Creates data management time lines with project team based on productivity standards and sponsor expectations
• Tracks data processing progress and communicates problems/backlogs to project team and management
• Maintains an awareness of the project scope of work and notifies senior management of all sponsor requests that are outside current scope in accordance with relevant SOPs
• Provides realistic team goals on a regular basis
• Defines expectations, roles and responsibilities of data management team members
• Calculate and monitor productivity on studies
• May participate and lead in the implementation of new technologies and services
• May present data management processes during pre-award meetings with potential sponsors
• Attends Investigator Meetings and presents data management functions

Confidential, Rockville, MD

Data analyst

Responsibilities:

• Perform all functions of the clinical data management process to ensure that the clinical trial database accurately reflects the data captured on the Case Report Forms for single or multiple clinical trials
• Track study process and produce status reports
• Perform database lock activities in preparation of data analysis
• Produce Case Report Forms completion instructions, data entry guidelines and various reports
• Responsible for answering, querying and posting of all data clarification forms
• Responsible for WhoDrug and Medra coding
• Responsible for writing and administering edit checks as well as annotated case report forms
• Administered Patient Profile auditing
• Developed MockCRF, ExpandedCRF, eCRF Review Manuals, and Instructions for Investigators.
• Performed RCA and CAPA forCRFdesigning and documentation activity.
• Provided input to study teams for creating User Requirement Specification for ePRO Medical Devices such as PEF (Peak ExpiratoryFlow) and Validation Testing of software of the same device.
• Generated Clinical Data Validation documents such as Data Validation Specifications, eCRF specifications, Edit Checks and third party Edit Checks, Validation Plan, Test Plan, Test Report, Validation Report, and Writing Test Scripts.
• Conducted software validation testing, i.e., executing User Acceptance Testing.
• Identified and issued manual queries to site for questionable data points.
• Coordinated with the coding team for ensuring coding of medical history terms, adverse events and concomitant medications are done on a timely basis.
• Planned and managed coding of adverse events, Serious Adverse Event.
• Assisted in preparation of interim data analysis and database lock.
• Ensured Quality Assurance of deliverables by peer review and following Good Documentation Practices, attended study specific kick-off meetings and actively participated in knowledge sharing sessions; ensured adherence to client SOP and meeting SLA; maintaining 100% compliance with company training and internal process.
• Review study protocol, provide feedback for any issues and provide inputs to build internal SOP.
• Provided training to data analyst on CDM Software and Documentation.