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6-10 years of experience
Responsible for creation of DMP (Data Management Plan) and Edit Checks Specifications, Edit Checks Testing and Validation for both Paper and EDC studies such as AGIIS (IVRS/IWRS), CAT, UAT and DTD Testing, Reports, Review and Validation. Data Cleaning/Discrepancy Management of paper-based and EDC projects according to the SOPs to ensure compliance with the study protocol. Support of the documentation, testing, implementation, validation, and utilization of systems used in Clinical Data Management activities.
- Recognized by Senior Department Managers for superior performance and requested by name to support other departments with tight deadlines.
- Received Award of Excellence for identifying critical discrepancies in the database that supported company's FDA submission for drug approval.
- Key member of a data quality improvement team that reduced data errors by 70%.
- Assigned by senior management to Project Initiation Group based on expertise in database design, report testing and database validation.
0-5 years of experience
Developed and updated Data Management documents (Data Management Plan, Data Validation Specifications, Data Entry Guidelines, CRF Completion Guidelines, Case Report Forms) while applying regulatory guidelines, standard operating procedures, and protocol requirements for 6 Phase I, on-going paper-based studies and 2 start-up studies on obesity and Type II Diabetes in Oracle-Clinical 4.5.3. Maintained study documents accordingly.
- Assisted in updating Data Management Standard Operating Procedures (SOPs) as needed.
- Trained Clinical Data Specialist on study-specific entry procedures(SSPs) for 6 on-going projects and 2 start-up studies; assisted in implementing plans for data processing within established time lines based on project needs.
- Performed validation & assisted with database QC and all data cleaning activities for all on-going and start-up studies with little supervision.
- Audited database of two studies nearing completion, documented findings, and generated error report.
- Furnished feedback and/or possible data management solutions to Senior Clinical Data Manager, Project Managers & Director of Clinical Affairs regarding on-going studies.
0-5 years of experience
Data management lead on 2 projects. Developed and implemented Data Management Plan, systems set-up, data accession, data entry and data review specifications and processes within timelines and budgets.
- Managed clinical data vendors utilizing strategic communication skills that increased productivity, quality and punctual delivery of projects.
- Developed and maintained close liaison with project client contacts, core team members and Project Managers.
- Performed date review, validation, query development and resolution.
- Implemented and maintained data auditing reports, metrics and tracking reports.
- Reviewed and revised all documents for Trial Master File.
- Conducted all database release activities.
- Computer skills include Phase Forward, inform, Oracle Clinical, CIWS, I-review, ClinTrial, Dictionary Coding, QRMS, SQL, CRAMS, IDX, UNIX, Microsoft Office XP.
0-5 years of experience
Performed a variety of independent activities involved in organizing and conducting research
studies within the overall scope of research projects in cancers
- Performed a variety of independent activities involved in the collection, analysis,
- Collected appropriate data; collected and verified patient data of about 1300 patients;
- Monitored patient progress to determine if individual patient endpoints such as:
- Educated Clinical Research Associates about data submission schedules, form
- Conducted Institutional Reviews and attendance of lectures/seminars on cancer
0-5 years of experience
Performed data management (DM) activities for the assigned clinical trials studies ensuring (CDM) procedures and processes to meet business requirements. e.g. (Performed as a lead to two complex studies: CRF tracking, reviewing, query generation, eTract mapping, resolving data clarification forms (DCFs) and a direct contact person globally).
- Archived and submitted relevant study documentation to the Document Records Center (IDRC) for indexing.
- Generated and reviewed ad hoc listings, reports and quality control documentation to facilitate validation of the clinical database; Reviewing Study Definition Matrix (SDM), Data Validation Procedures (DVP), Data Management Plan (DMP) to ensure data consistency.
- Performed assigned tasks independently and within timelines according to the CDM Project Plan, SOPs and Sponsor specific requirements.
- Maintained study documentations for the project team. (E.g. archiving documentation in the Database Data Management System (DDMS), obtaining study required document signatures).
- Interacted regularly w/ the DM team for newly assigned tasks & communicating with the assigned teams globally. e.g. (CFO's, CRA's, Monitors).
- Coordinated weekly meetings of CDM Early Development Therapeutic area team.
0-5 years of experience
Used InForm to clean hypertension study data in accordance with SOP's and the protocol.
- Managed team of 5 on hypertension study. Conducted team meetings; managed weekly schedules and confirmed accuracy of timesheets
- Handled data collection, ensuring accuracy and consistency of clinical data, and reviewing processes to ensure compliance with internal and external guidelines
- Resolved data discrepancy and related issues by interacting directly with investigator sites
- Authored data discrepancy and applied data changes resulting in resolved discrepancies
0-5 years of experience
Performed data cleaning activities for Phase II & III global and domestic studies
- Administered user database for an Inform (including LNMT) trial
- Communicated study metrics to clients, vendors, and internal team members
- Documented clinical data management processes and procedures
- Reconciled discrepancies between CTMS and external data sources
- Wrote Change Orders & UAT scripts for one EDC (InForm) trial, perform UAT for other studies
- Studies are in the areas of Oncology, Renal and Hepatic
0-5 years of experience
Data Management team leader of multiple projects (phase II, III and IV) for a global, full service Contract Research Organization. Implementation: Oracle Clinical Data Base Management System. Therapeutic areas: Hepatitis B, Acute Coronary Syndrome and Acute Myeloid Leukemia.
- Liaison with clinical team and clients to effect successful project outcomes
- Supervised and trained project personnel; organized and oversaw all quality control work done
- Developed and maintained project files (including DM Plan, Edit Checks and Entry Guidelines)
- Directed all DM activities and quality of work done; monitored actual time against contract time allocated
- Hands on project work: discrepancy reconciliation and SAS datasets review plus Serious Adverse Event reconciliation
- Received Spot Award in 2004 and an employee exemplification bonus in 2005
0-5 years of experience
Acted as a Lead Clinical Data Manager for one or more projects, provided support to the Lead Clinical Data Manager.
- Worked on 2 phase 3 studies (endocrinology - diabetes)
- Supervised a team of data entry operators and clinical data coordinators.
- Liaised with clients and colleagues in other functional groups as required.
- Projected delivery responsibility; meeting timelines and deliverables of the projects.
- Prepared and maintained DMP (Data Management Plan) and project status reports.
- Designed & prepared Case Report Forms (CRFs).
10+ years of experience
Managed and analyzed clinical drug development data for Phase III global cardiovascular trials
- Set-up. Audited and maintained data in INQUIRE Databases, on the IBM
- Programmed in SAS, on the IBM 3090, under VM/CMS and MVS and on the HP 3000, under the MPE operating system
- Prepared oral and written communications to clinical task force
- Supervised and instructed data management specialist and data entry personnel
0-5 years of experience
Clinical data review/data clarifications on intermediate complexity projects using OC/Clintrial.
- Documented, resolved, and integrated data queries while interacting with project team/teams.
- Reviewed data discrepancy listings with query documentation and resolution.
- Edited database and Case Report Form (CRF).
- Performed quality control review of the CRF against the database.
- Involved in testing of validation programs to ensure database quality and integrity.
- Liaised between Client/Site/Safety for associated Serious Adverse Event Reconciliation.
0-5 years of experience
Independently perform all data management functions to ensure quality and timely data entry for multiple Phase I studies.
- Track and record all adverse events across multiple trials. Assure SAE's are reported on time and to the required agencies per established protocol guidelines.
- Work closely with nurse coordinators and physicians to analyze, summarize and assess AE's from physical exams, labs, consultations, and clinical signs.
- Participate in Data Safety Monitoring Committee audits of in-house studies. Contributed by reviewing patient charts for adherence to specific protocol guidelines, and to ensure patient safety.
- Communicate effectively with all clients and clinical staff to ensure all queries are resolved, and all study goals and endpoints are being attained and met.
- Trained, certified and familiar with various CRO databases, including; Medidata Rave, Inform, Oracle, c3d and others.
0-5 years of experience
contract position
Performed data management tasks on over 30 Phase I-III clinical studies. Wrote and instituted Data Management Plans (CDMP); Designed Case Report Forms (CRF); Set up, reviewed and tested Oracle Clinical databases; Created, tested and implemented Validation Procedures; DCFs (data clarification form) generated, issued and processed with updating of database; Reconciled serious adverse events (SAE) with Pharmacovigilance database; Reconciled PK/PD files, Reviewed tables and listings ongoing basis and prior to database lock.; Prepared study documentation for regulatory review.
- Locked over 28 databases either early or on schedule, working with Clinical, Statistics, SAS Programming and Oracle Programming.
- Wrote and instituted reconciliation procedures for PK/PD files assuring complete integration into database which prevented errors and saved 2days or more of the locking process.
- Audited returned CRFs for completeness and readability in preparation of entry which saved time and prevented incorrect entries.
0-5 years of experience
Assisted Clinical Research Nurses with screening patient's eligibility as required by protocol
- Assisted the Nurse Coordinator with the screening and sorting of medical records relevant to Serious Adverse Event (SAE) reports
- Verified the accuracy and completeness of CRFs
- Reviewed and resolved clinical data discrepancies and queries
- Assisted the monitor with study start -up, prepared for monitor's interim visits, and prepared for study close-out on Phase I-IV
- Prepared films for radiology interpretation, and recorded tumor measurement assessments
- Maintained a log and tracking system for study-related information
0-5 years of experience
Responsible for establishment, development and implementation of data management department.
- Created standard operational procedures to ensure compliance with protocols, regulatory guidelines and overall clinical objectives.
- Responsible for hiring, training and supervision of staff.
- Designed and developed a SAS based data management system to control database entry, data coding, quality and tracking of clinical trial data.
- Developed data management plans, created study databases, designed case report forms and programmed electronic edit checks for all new studies.
- Performed data collection, data review, query reporting, and query resolution activities in support of database locks for multiple clinical studies.
- Provided programming expertise in the analysis and reporting of clinical trial data.
- Participated in conversion project of existing systems to DataFax data management system.
0-5 years of experience
Managed small clinical trial projects and assisted with large projects from study start-up to database lock.
- Created and maintained study documentation, including data management plan, CRF completion guidelines, and data entry guidelines.
- Created validation specifications, developed dummy data, performed user acceptance testing.
- Reviewed case report forms and data listings for discrepancies, and generated, tracked, and integrated queries in compliance with GCP.
- Performed SAE reconciliation and lab data reconciliation.
- Assisted with database audits.
- Interacted with clients and project team to ensure clean databases.
0-5 years of experience
Acted as Lead Data Manager for multiple studies and indications including an HCV and HIV Study with approximately 17 million patients entered into trial. Responsibilities included:
- Development and design of study specific data management documentation including Data Management Plan, Data Entry Guidelines, Edit Check Specifications, testing of Data Entry Screens etc.
- Responsible for the resolution and correction of all database discrepancies to assure consistency of data collection and validation in providing a clean, quality locked databases.
- Mentored junior level staff on all associated tasks within a study.
- Set and met timelines. Recognized and scheduled changes in response to project demands
- Oversaw all activities that ensured the completeness and validity of the clinical trial database, including authoring the data validation and query management process, adverse event and medication coding, and SAE reconciliation.
- Helped develop and maintain general data management Standard Operating Procedures (SOP's) as well as study specific Working Practices (WP's) related to the data management needs of specific projects
0-5 years of experience
Responsible for implementation and coordination of clinical data management activities supporting clinical trials in Fibromyalgia, from study start up to database close:
- Directed data management review of Protocol amendments and assured CRF accuracy and design.
- Conducted User Acceptance Testing of data entry screens to reflect protocol requirements, providing a streamlined, timely, and efficient database roll out.
- Represented data management in all project team meetings and provided status and updates on regular basis.
- Generated, processed, tracked, and resolved all electronic and manual queries.
0-5 years of experience
Compiled patient information from various sources in order to ensure that information was uniform and in line with guidelines set up by the United Network for Organ Sharing and Cardiac Transplant Research Database.
- Updated and maintained the database for Heart Failure / Transplant Center.
- Collaborated with staff from various institutions on collection and update of patient transplant data and entered said data into database.
- Designed Excel spreadsheets in order to store and collect data for various research projects.
- Worked as part of a team to develop statistical analysis and interpret the data.
0-5 years of experience
Primary responsibilities included issuing and resolving data discrepancies in Inform for AEs and CMs.
- Managing the LNRs (Local Lab Normal Ranges) and Local Lab Reconciliation.
- Reviewing Patient Profile Comments from Clinical and generating queries when necessary.
- Provided assistance to Sites on reconciliation of queries via email.
- Participated in project/team meetings to give a status update to upper management.
- Documented and addressed any errors, omissions, or inconsistencies found during data review.
- Applied corrections and/or updates that were identified through query resolution or other sources to appropriate documents and databases.
0-5 years of experience
Lead data management team in coordinating the data review, clarification, and quality control of assigned Phase IV Orthopedic Clinical Study.
- Completed data management activities under SOPs and policies of the sponsor.
- Developed and maintained Data Management Plan, edit specifications, and other relevant documentation associated with assigned protocol.
- Assisted in database design, testing, and maintenance, CRF and guidelines creation, process maps, and SOP development.
- Interfaced with members of Study Team and sponsor to provide weekly updates, resolve project related issues, and provide data management expertise to all aspects of the study.
6-10 years of experience
Assisted new team members, Statisticians and Certified Research Associates on the Oracle Clinical system
- Educated new and current users on research methods to achieve an understanding of medical terminology, common lab tests and cancer treatments
- Managed Leukemia/Lymphoma clinical trials to include quality control and evaluation of clinical patient data.
- Validated that eligibility, toxicity, response, follow-up, and survival data are accurately coded and updated in the database to assist the Study Chair and Statistician to prepare database for analysis
- Reviewed and provided input for protocols and addenda in development, as well as contribute to the development of case report forms and associated submission schedules, parameters and program set up
0-5 years of experience
Performed data review activities such as generation of queries both programmed and manual, query updating, resolving of data entry flag reports, run metrics reports, etc.
- Updated the Clintrial Database from Data Revision Forms and Data Verification Request Forms.
- Performed Clinical Data Review and Query Maintenance.
- Updated SAS listings and Adhoc listings.
- Ensured that Standing Operating Procedures were being followed.
- Trained and mentored new data review employees.
- Analyzed, reviewed and generated queries based on coding reports.
- Maintained study documentation both electronically and in study documentation binder.
0-5 years of experience
Provided status reports, as requested, on the progress of trial.
- Managed the resolution of discrepancies and associated activities within data management for assigned centers, including resolving data entry errors and applying self-evident corrections, and generating DCF's.
- Incorporated changes resulting from manual review of data listings and updated the Clin Trial database with DCF resolutions.
- Generated and resolved discrepancies involving trial data using CT4 database.
- Ensured the quality of clinical trial data as required per protocol.
- Performed SAE resolutions.
- Promptly met the team's deadlines to ensure data lock.
0-5 years of experience
Coordinated and performed study start up activities using Clintrial database system
- Developed and maintained project specific database, created CRFs including eCRFs via Clintrial and Inform software
- Defined, tested and performed validation checks; performed data review and query generation
- Participated and presented in study team meetings
- Generated status reports and project specific summaries via SQL and/or in house program
- Created data management timelines, and tracked data progress identifying and providing resolutions as needed
- Project and financial management activities
- Supervised and trained assigned resources
6-10 years of experience
Ensured data quality and integrity across Phase II and III Cardiovascular compounds and all therapy compounds for Phase I clinical trials:
- Responsible for data processing activities including CRF review, coding data, evaluating
- Worked with study sites, investigators and clinical monitors to execute clinical study design
- Managed five direct reports
- Responsible for employee orientation and training
- Created employee training manual and reference guides used by all Data Management
- Wrote and evaluated SOPs and general working practices
0-5 years of experience
- Direct supervision of nine coding staff
- Manage the clinical documentation improvement program which included 3 coders and 3 Utilization Review Nurses
- Monitored Discharged Not Final Billed to maintain established benchmark
- Served on various committees including the Revenue Cycle Committee and Compliance Committee.
0-5 years of experience
- Performed all aspects of data management from study set-up to database lock.
- Planned, prioritized and addressed multiple projects and resources.
- Developed training documentations and conducted training sessions for new data reviewers
- Communicated with upper management, status and progress of each clinical protocol.
- Revised and developed standard operating procedures (SOPs), CRF completion guidelines and self-evident changes documents.
0-5 years of experience
Ensured timely ongoing quality management of clinical trial data by identifying inconsistencies in CRF data.
- Data processing including updating, cleaning, quality checks on the database, and Serious Adverse Event reconciliation to highlight discrepancies.
- Generated listings via IReview for manual review and utilized patient profiles to review Oncology data.
- Ensured clean data resolution was in order for database locks.
- Generated, resolved and closed queries after site correction for paper based studies.
- Responsible for audit checks and reports necessary to assure high quality and consistent data.
- Supervised contract research organization (CRO) to perform data management functions.
- Monitored query responses for error identification.
0-5 years of experience
Acted as a Lead Clinical Data Manager for multiple projects, also provided support to other Lead Clinical Data Managers 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 Guidelines (DVG) and/or client documentation.
- Designated tasks appropriately within the team ensuring all work conducted were completed to the acceptable quality in accordance with global Standard Operating Procedures (SOPs) and the DVM, DVGs.
- Represented Clinical Data Management at internal and external meetings and presentations.
0-5 years of experience
Reviewed data for accuracy, completeness and consistency as well as generated
standard edit checks, data listings and reports.
- Assisted in data management tasks such as processes to track and resolve queries and participated in protocol review
- Provided administrative and technical support to team members in the use of clinical
- Assisted in the development of data documentation manuals and maintain data entry
0-5 years of experience
Conducted data analysis of departmental guidelines and procedures to ensure processes were streamlined.
- Prepared forms for data entry as determined by data management to review guidelines and standard departmental procedures for a given study.
- Reviewed patient records during ongoing studies to ensure patient cases were current and complete.
- Developed close working relationships with various departments and management.
0-5 years of experience
Managed clinical study trials, Phases II to IV, in cardiovascular and metabolism development.
- Cleaned, resolved, and queried trial data through the use of Trial Monitor, Trial Recorder and ClinTrial (CT4) software in EDC.
- Prepared, reviewed, and tracked electronic Case Report Forms (eCRFs).
- Conducted Quality Control (QC) of patient visits.
- Crosschecked serious adverse events (SAEs), dosage administration records and concomitant medications.
- Abided by drug study protocols set by trial and FDA regulations.
- Attended training programs in FDA compliance, QC, SOPs, GCPs, Central and Local Lab reconciliation as well as efficient data management.
0-5 years of experience
Served as Lead Data Manager for two oncology protocols
- Responsible for strategies and timelines with regard to all Data Management activities through to database lock
- Performed duties related to editing and preparing clinical data for analysis
- Independently reviewed and resolved discrepant data in the clinical database. Review was done via programmed edit checks, data listings and SAS listings
- Provided regular updates to study team and management
- Functioned as primary client contact for data management
- Ensured compliance with established SOPs and current regulatory requirements
- Managed & assisted in mentoring assigned employees with the Data Management group
0-5 years of experience
Created data management plan, data transfer specification documents, data review guidelines, data entry guidelines and work instructions.
- Served as lead data manager on multiple projects during same time period.
- Trained and assigned tasks to junior data management personnel.
- Led data collection and data clean-up activities including ongoing site management for issue resolution.
- Utilized SAS to ensure data readiness for analyses and locks.
- Built eCRFs and implemented edit checks in the Adaptive clinical database system.
- Rectified project tracking system for data management activities.
- 2012 - entered organization as a Smith Hanley Consultant and subsequently accepted employment
0-5 years of experience
- Led Data Management trainings for clinical site staff at domestic and international investigator meetings.
- Proactively conducted technical aspects of clinical data management from study startup to close.
- Directed the development of edit check specifications for EDC systems.
- Designed CRFs/eCRFs based on clinical research protocols and needs of the sponsor.
- Communicated expertise regarding data management matters for the clinical research team.
0-5 years of experience
Provided input into edit specs including creating, testing and implementing data edit checks and data listings
- Reviewed protocols for proper data capture including Case Report Form (CRF) design and CRF completion guidelines
- Processed data query forms to be resolved at investigational sites within Inform, RAVE & OC-RDC EDC systems
- Delivered quality database(s) to stakeholders and communicate any clarifications or details that would affect the data analysis (interim or final) to the statistician.
0-5 years of experience
- Performed all clinical data activities on assigned projects including pre-entry data review, data validation and query integration and resolution. Utilized study documentation including protocols and case report forms to perform review and validation
- Assigned appropriate action to resolve data discrepancies
- Generated queries based on protocol guidelines and client specific needs
- Tracked and integrated queries by updating database and case report forms as needed to comply with project standards
- Performed audit functions to ensure quality of data
- Participated and contributed as an active member in project team and departmental meetings and followed through on actions/plans set forth during meetings
0-5 years of experience
- Created and maintained Data Management Plans and other key study documents
- Created, reviewed, and processed Data Clarification Forms and updated the databases as needed
- Managed the clinical Data Management process for multiple studies
- Liaised with sponsors, attended sponsor meetings, and produced study progress reports
- Performed vendor data reconciliation (labs, ECGs, images), SAE reconciliation, and medical data listing review
- Administered EDC-system training to clinical site staff, including Site Coordinators and Investigators, as well as Clinical Research Associates
0-5 years of experience
Implemented first in-house EDC system DataTrak
- Identified backlog of data to be entered into EDC system
- Assisted CRA in tracking and reconciling SAE reports
- Oncology Clinical Data Manger for six trials, create patient profiles for Medical monitor,
- Trained Clinical Coordinators on EDC system and data submittal procedures
0-5 years of experience
- Reviewed and validated clinical database using medical background and review guidelines; updated the study database through assumable corrections and data review; generated and tracked all queries through to resolution.
- Reconciled laboratory data from central safety and microbiological laboratories.
- Reviewed all new laboratory reference ranges and submitted to the study database.
- Created a CRF cleaning checklist for the data managers; assisted in the development of review guidelines and edit checks.
0-5 years of experience
home based)
Performed data management activities for two trials in maintenance mode. (Received Spot Award due to outstanding job performance)
- Performed UAT testing for e-dairy.
- Revised eCRF instructions.
- Coordinated a data freeze to be used in an annual report.
- Reviewed clinical data via I-Review, e-diary, and Inform.
- Created, reviewed, and processed Data Clarification Forms and updated databases.
- Supported training of project team on project specific and data management processes.
- Performed reconciliation of SAEs.
- Liaised with monitor, database programming, medical coding and statistical programming teams to ensure smooth functioning of studies.
0-5 years of experience
Served as the Lead Clinical Data Manager (CDM) for phase II gene therapy trial
- Supervised team of CDMs insuring study time lines and quality standards were met
- Trained CDMs to comply the Study Specific Guidelines
- Acted as the liaison and provided instruction to contracted Clinical Research Associates in the field
- Communicated directly with Study Coordinators at site to insure adherence to study guidelines
- Review and clean data from Clinical Trials for FDA submission, including SAE/AE reconciliation
- Represented the Data Management Department at study team teleconferences
- Gained experience in several therapeutic areas including oncology, autoimmune diseases, and hemophilia
0-5 years of experience
- Managed planning, coordination and completion of assigned studies
- Estimated resources required to meet the projected study timelines
- Ensured consistency across protocols within projects and across external providers
- Ensured early CRO involvement in outsourced study activities
0-5 years of experience
- Quality controlled CRFs for conformity to protocol/SOP guidelines and wrote and resolved both manual and automated queries as part of data cleaning activities.
- Interacted with sites to ensure timely and accurate completion of CRFs.
- Helped develop CRF guidelines to achieve data integrity.
- Assisted in the training of new Data Associates.
0-5 years of experience
Coordinated review of clinical data for various Clinical Trials.
- Successful completion of multiple Clinical Studies, ensuring all required objectives have been met.
- Organized the design, validation of Case Record Forms.
- Responsible for generating and resolving Data Clarification Requests, tracking all through resolution while working collaboratively with Clinical Coordinators and Clinical Research Associates.
- Developed and provided CRF training to Monitors. Provided training and mentoring of new staff.
- Designed system to track and accurately complete laboratory reconciliation.
0-5 years of experience
Responsible for the planning, implementation and overall direction of executing/achieving clinical trial data management
activities including Electronic Case Report Forms (eCRF) design, database development, validation programming,
discrepancy management, and database release
- Created training manuals and trained clinical teams on the use of Electronic Data Capture (EDC) system user interfaces for data entry, queries and reports
- Supervised all Clinical Research Organizations (CRO) relationships and performance with the Company
- Oversaw the development and maintenance of the components of the study Data Management Plan (DMP). The DMP
- Strong technical skills and knowledge of data management database systems
- Interact with Biostatistics, Clinical, and Regulatory personnel on a daily basis to ensure compliance with protocols, Standard
6-10 years of experience
- Experience working on Oncology studies, Transplanting, Central Nervous System studies, Monitored the progress of clinical trial projects for timely attainment of milestone.
- Developed Data Validation Specification guidelines and Case Report Forms (CRF). Reviewed Case Report Forms (CRF).
- Generated and reviewed data discrepancy listings with associated data query documentation, resolution, and integration. Checked, edited, reviewed and clarified adverse events, concomitant medications and other data as needed on projects.
- Compared and reconciled adverse event data captured in Drug Safety and against database. Tracked and reported data management status.
0-5 years of experience
Managed Breast Oncology Trials data for successful completion of protocols according to SOPs for Investigator Initiated, Correlative Studies and Cooperative Groups and Pharmaceutical Sponsor
- Interfaced with study sponsors, monitors and tracks regulatory submissions
- Participated in site initiation visits to start-up new Breast Oncology trials
- Ensured investigator compliance with IRB policies and approval, AE, & SAE site management
- Maintained data pertaining to research projects, completes source documents/case report forms, and performs data entry
- Designed forms for the clinical trails office and data collection tools; verified data on case report forms
- Attended study meetings, participated in on-call schedule as needed and submitted weekly ongoing status reports of assignments
- Assisted with quality assurance and tracked regulatory submissions
0-5 years of experience
- Presented at Investigator Meetings overseas and EDC Kickoff Meetings
- Lead Data Manager on 4 studies (Inform and Medidata RAVE) at the same time
- Provided mentoring and training to new staff and data reviewers
- Created edit check and custom listing specifications
- Created eCRFs, Data Management Plan and eCRF Completion Guidelines
- Reviewed budgets on a monthly basis and participated in budget meetings
