Job Summary:

• Assist in defining and creation data listings, including programming software to generate listings.
• Data specifications and/or process data transfers in preparation for statistical review.
• Validation of electronic data capture (EDC) systems at a study level. 
• Experience developing study requirements, test scripts, and UAT documentation.
• Administration of EDC systems (possibly for multiple studies simultaneously).
• Training users on EDC systems. 
• Create training documentation and running training sessions for end users.
• Create, report, and send data using Excel.
• Develops, maintains, and utilizes data sets required to support key reporting activities
• Conducts system/data integrity and quality checks/audits
• Develops monthly invoices for payments and follows up on timely collection

Skills on Resume:

• EDC Validation (Hard Skills)
• Data Management (Hard Skills)
• EDC Administration (Hard Skills)
• User Training (Soft Skills)
• Documentation Development (Hard Skills)
• Excel Reporting (Hard Skills)
• Data Integrity (Hard Skills)
• Financial Management (Hard Skills)

Job Summary:

• Use multiple data sources to fulfill requirements of quality measures
• Responsible for learning/maintaining quality program requirements.
• Ability to navigate and understand multiple clinical data repositories including various EHRs
• Ability to troubleshoot and problem solve for data accuracy and coordinate with team to address discrepancies and maintain data integrity
• Adhering to all Continuum Health guidelines.
• Ensures appropriate CPT codes using an electronic encoder system for admitting and discharge diagnosis, encounter forms, patient charts, and all other records. 
• Identifies abstract and follows up on missing codes for accurate billing for pre-determined protocols. 
• Performs all functions of the STAR system for registration and PHS system in scheduling appointments. 

Skills on Resume:

• Data Quality Assurance (Hard Skills)
• Quality Program Mastery (Soft Skills)
• Clinical Data Navigation (Hard Skills)
• Data Troubleshooting (Hard Skills)
• Health Guidelines Adherence (Soft Skills)
• CPT Coding (Hard Skills)
• Billing Code Abstracting (Hard Skills)
• System Registration (Hard Skills)

Job Summary:

• Perform primary review of submitted clinical data, entry into databases and source document verification according to established standard operating procedures (SOPs).
• Participate in review and verification of data for quality control processes.
• Organize clinical documents according to SOPs and federal requirements.
• Ensure quality in documentation and archiving of clinical data.
• Perform central data monitoring and create data queries.
• Communicate to clinical team and CRAs important findings that require clinical site notification.
• Assist in the development and implementation of efficient data management systems to accomplish protocol objectives.
• Generate reports and participate in data analysis and data quality analytics.
• Maintain study information, systems and tools for clinical trials.
• Other duties may include preparation of study supplies and participation in investigational product and clinical sample (e.g. pathology slide) inventory management.

Skills on Resume:

• Clinical Data Review (Hard Skills)
• Data Quality Verification (Hard Skills)
• Clinical Document Organization (Hard Skills)
• Data Quality Assurance (Hard Skills)
• Data Monitoring (Hard Skills)
• Clinical Communication (Soft Skills)
• Data System Development (Hard Skills)
• Data Reporting (Hard Skills)

Job Summary:

• Regularly reviews and queries clinical trial data and reviews for trends/signals. 
• Suggest queries and report trends to the internal teams and CROs
• Supports the Clinical Data Manager with the EDC system development process with each CRO from initial set-up through database lock
• Review URFs, UAT Plan and testing of clinical study databases along with review of edit check specifications and manual data listings 
• Works closely with CRO database builders during programming of EDC databases and edit checks
• Review all essential data management documents with CROs, including CRF specifications, eCRFs, annotated eCRF, eCRF completion guidelines, Data Management Plans (detailing complete data management processes throughout clinical studies), Data Review Guidelines, Data Entry Guidelines, Data Transfer specifications and laboratory data handling
• Provides feedback on draft protocols, CSRs and other documents 
• Helps design listings in support of clinical and medical review of data
• Ensure clinical databases and external data files are designed in a consistent format to produce dataset that are conducive to analysis. 
• Coordinate deliverables with data management and statistical vendors such: SC briefing documents, IND Annuals, DSUR, safety listings. 

Skills on Resume:

• Data Trend Analysis (Hard Skills)
• EDC System Support (Hard Skills)
• Database Testing (Hard Skills)
• CRO Collaboration (Soft Skills)
• Data Management Review (Hard Skills)
• Document Feedback (Soft Skills)
• Listing Design (Hard Skills)
• Data Coordination (Hard Skills)

Job Summary:

• Coordinate data cuts/transfers and conduct data reviews
• Review all statistical assumptions and provide input on deliverables: SAP, TFLs
• Maintain all data management internal files, ensuring preparedness for regulatory inspections
• Participate on project and program teams including multi-disciplinary interactions 
• Ensure clear overview of progress, risks and mitigation strategies by all participants for all data management related deliverables
• Responsible for tracking individual project tasks and overall data management timelines
• Regularly provide CRF performance overview to CRAs and help prioritize the on-site data cleaning as per clinical timelines
• Participate in the development and maintenance of data management SOP’s and related control documentation.

Skills on Resume:

• Data Transfer Coordination (Hard Skills)
• Statistical Review (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Team Collaboration (Soft Skills)
• Risk Management (Soft Skills)
• Project Tracking (Hard Skills)
• CRF Performance Analysis (Hard Skills)
• SOP Development (Hard Skills)

Job Summary:

• Prompt review of clinical and biospecimen data from the CPTAC program
• Write small programs/scripts for formatting, analysis, presentation and tracking of data
• Communicate well and address issues in a friendly and prompt manner
• Apply data analytics and look for trends to use as quality metrics in Tissue Source Site data entry errors and provide constructive solutions
• Apply the appropriate level of clinical knowledge to data management and noncompliance issues and work to resolve them
• Work well with all members of the team and coalesce multiple aspects of the program
• Communicate the identified issues in clinical data to the data entry team in a professional manner with a potential solution
• Follow up on the corrected data and check for data integrity across multiple forms
• Ensure case data meets the requirements of the associated project protocol, Clinical Research Form standards templates, Good Clinical Data Management Practices and where applicable Clinical Data acquisition standards through both manual and automated review
• Assists in the setup and review of data management documents including SOPs and operational activities such as user training
• Writes scripts and SQL queries as needed to automate review and analyze data
• Responsible for clinical data submission to public portals and coordinate releases
• Provides status updates to the management team on a regular basis through reports, tables and figures

Skills on Resume:

• Clinical Data Review (Hard Skills)
• Script Programming (Hard Skills)
• Effective Communication (Soft Skills)
• Data Analytics Application (Hard Skills)
• Team Collaboration (Soft Skills)
• Data Integrity Monitoring (Hard Skills)
• Data Management Support (Hard Skills)
• Data Submission Coordination (Hard Skills)

Job Summary:

• Provide timely access, effective facilitation, and appropriate use of data tools
• Coordinate data collection, extraction and validation, and supports outcome analysis and information presentation for a variety of internal and external customers to create best clinical practices
• Authorize access to source and subject area data marts, reports, scorecards and dashboards within the EDW on the basis of “need to know”
• Work with the Data Architect and Outcomes analyst to define access roles to the data warehouse
• Work with front-line clinicians and Clinical Program leaders to identify which data elements must be captured to manage a care process effectively
• Work collaboratively with Clinical Program leaders and Evidence-based Practice Outcomes Center to review current literature and to identify and consult national experts concerning key clinical processes
• Demonstrate a solid understanding of proven project management principles
• Resource allocation, cost tracking, monitoring project scope and project risk management

Skills on Resume:

• Data Tool Facilitation (Hard Skills)
• Data Coordination (Hard Skills)
• Access Authorization (Hard Skills)
• Role Definition (Hard Skills)
• Clinical Data Capture (Hard Skills)
• Collaborative Review (Soft Skills)
• Project Management (Hard Skills)
• Resource Management (Hard Skills)

Job Summary:

• Identifies, compiles, updates and maintains cancer diagnosis data from a range of relevant sources, including hospitals, laboratories and medical offices as well as various electronic health care record systems and follows procedures to facilitate data collection as appropriate.
• Ensures complete and accurate data are collected and maintained for all eligible cancer cases diagnosed and/or treated.
• Abstract data into EMR including but not limited to staging, diagnosis, extent of disease, etc. from various medical sources
• Reviews data for completeness, consistency and accuracy. 
• Pursues additional information from data sources as necessary, updates/corrects data
• Performs life-time follow up on patients status, treatment and progression of disease for quality improvement activities, administrative planning/marketing and support programs.
• Assists in instructing/updating clinicians on current disease process staging and biomarkers.
• Attends relevant tumor boards.
• Provides input into study/review planning, report writing, data analysis under the supervision of manager.

Skills on Resume:

• Cancer Data Compilation (Hard Skills)
• Data Accuracy Assurance (Hard Skills)
• EMR Data Abstraction (Hard Skills)
• Data Integrity Review (Hard Skills)
• Patient Follow-Up (Hard Skills)
• Clinician Education Assistance (Soft Skills)
• Tumor Board Participation (Soft Skills)
• Research Support (Hard Skills)

Job Summary:

• Train customers on THREAD’s current data services
• Elicit requirements for any custom data needs
• Formalize any Data Transfer Agreements (DTA) with the customer Data Management team and work with the THREAD technology team to execute against
• Perform quality control review for customer deliverables (DTA, Mapping Documents, etc.)
• Work with THREAD product team to review and give product recommendations on Data Transfer Agreements, data set mapping, exports, and transfer, etc.
• Act as Subject Matter Liaison for both THREAD and Customers
• Assists in data abstraction for QOPI 
• Works with staff to ensure efforts are coordinated and high quality patient care is provided.
• Attends required meetings and participates in committees 
• Participates in professional development efforts to keep current on health care trends and practices.
• Maintains patient confidentiality with regard to the release of any patient related information and follow practice policies regarding same.

Skills on Resume:

• Customer Training (Soft Skills)
• Requirements Elicitation (Hard Skills)
• DTA Formalization (Hard Skills)
• Quality Control Review (Hard Skills)
• Product Recommendation (Hard Skills)
• Subject Matter Liaison (Soft Skills)
• Data Abstraction (Hard Skills)
• Professional Development (Soft Skills)

Job Summary:

• Ensures integrity of clinical trial data in different processes: planning databases, data cleaning and data reconciliation, including production and QC of clinical data outcomes for the final study report.
• Support technical to the clinical team in in-house and on-site monitoring of clinical trials.
• Develops / reviews DM plans.
• Involved in the design, the review and the testing of the clinical database.
• Develops / reviews programmed and manual edit checks intended to identify and clean up discrepancies in the data entry.
• Organizes and performs data coding reviews, progress reports and data reconciliation.
• Provides operational support to the Clinical Trail Manager in data cleaning activities upon study database lock, verifies integrity of data collected from different study vendors.
• Designs/reviews forms for receiving, processing, or tracking data.
• Ensures study data collection processes adhere to the study protocol, regulatory and ethical requirements, ICH-GCP regulations and Standard Operating Procedures.
• Assess the data collected at clinical sites by the responsible personnel on an ongoing basis.
• Involvement in data collection initiatives to verify protocol compliance and quality of collected data and prepares appropriate intervention plans for the avoidance of errors and deviations from the protocol.
• Involvement in selection of CRO and other vendors (IVRS/IWRS, diary if applicable) as subject-matter expert.
• Training of the CRO/vendor/sites and site research personnel on technical data management processes or software program usage.
• Ensures integrity of the locked data, collaborates with biostatistician on production of study outputs, QC of TLFs together with clinical and biostatistics teams.
• Provide assistance to pharmacovigilance, biostatistician and/or clinical trial manager with project or study related data collection/data interpretation activities.

Skills on Resume:

• Data Integrity (Hard Skills)
• Technical Support (Hard Skills)
• Database Testing (Hard Skills)
• Data Cleaning (Hard Skills)
• Data Reconciliation (Hard Skills)
• Form Design (Hard Skills)
• CRO Training (Soft Skills)
• Regulatory Compliance (Hard Skills)

Job Summary:

• Maintain and analyze IRB operations metrics and reports for the WCM IRB office in support of process improvement initiatives.
• Develop, implement and lead outreach efforts with the WCM research community based on needs in areas of human research and IRB operations, e.g. presentations, webinars, technical training in the Weill Research Gateway systems, human research compliance training sessions, etc.
• Lead and/or conduct tailored outreach (training and education, regulatory guidance, etc.) with WCM departments and/or divisions.
• Serve as project manager for internal and external QA and process improvement initiatives, including, but not limited to: policy development, SOP development, business workflow analysis, development of HRPP tools for research community.
• Exercise independent judgement in analysis of and proactively identify areas and strategies for improvements in the WCM HRPP.
• Serves on internal subcommittees, e.g. policy subcommittee, process improvement, etc. to assist with building the WCM HRPP.
• Maintains an advanced working knowledge of federal, state and local regulations and institutional policy and procedures
• Ensure the WCM IRBs and HRPP are in compliance with applicable mandates.

Skills on Resume:

• IRB Metrics Analysis (Hard Skills)
• Outreach Development (Soft Skills)
• Regulatory Training (Hard Skills)
• Project Management (Soft Skills)
• Process Improvement (Hard Skills)
• Subcommittee Participation (Soft Skills)
• Regulatory Knowledge (Hard Skills)
• Compliance Management (Hard Skills)

Job Summary:

• Providing technical and strategic leadership for big clinical data projects, including an all-comers real world clinical registry
• Building creative and world-class solutions that utilise biostatistical methods and models to solve major challenges in big clinical data and to address business needs
• Ensuring that clinical data collection methods are implemented and maintained according to industry best practice and standards across all customer bases
• Working with stakeholders from across the company and externally to identify project requirements and evaluate and implement solutions
• Leading and developing a small team to ensure clinical data is fully utilised for business needs into the future
• Managing projects from concept to evaluation, delivering projects to a very high standard of completion, on time and within budget
• Communicating and presenting clinical data to meet business needs
• Bringing scientific and statistical rigour to all elements of work
• Upholding CMRs core values ambitious, humble, people focused and fair and responsible

Skills on Resume:

• Technical Leadership (Soft Skills)
• Biostatistical Solutions (Hard Skills)
• Data Collection Standards (Hard Skills)
• Stakeholder Collaboration (Soft Skills)
• Team Development (Soft Skills)
• Project Management (Hard Skills)
• Data Communication (Soft Skills)
• Statistical Rigor (Hard Skills)

Job Summary:

• Oversee the data management initiatives of internal and external vendors
• Participating in Study startup, SAE reconciliations, Protocol development, Data Validation, and Database closeout/lock.
• Ensure data management deliverables for clinical trials are delivered for all Trial groups and provide clear concise status updates.
• Delivery of the Data Management Plan and associated components (including Biosample Management Plan, Data Validation Specifications, Data Quality Components and Data Review Plan)
• Facilitates Data Management, Data Acquisition for Report Generation, Data Integration, Data Visualization and Reporting.
• Develop new or Enhance available tools to support the review of clinical study data in early phase studies.
• Develop and Execute data flow plan and automated data review/data cleansing process that decreases the burden on study teams.
• Integrating, transforming, analyzing, and performing predictive identification of problematic data to address problems in data areas.
• Drive consolidated feedback to cross-functional teams in order to increase the efficiency of data review and collection across the clinical departments.
• Work directly with the study teams and department head to lead the aggregate review of clinical data by patient, site and project to identify data trends and data inconsistencies that require further investigation.
• Manage project timelines and metrics to ensure the integrity of a database.
• Establish standard processes and procedures for the Data Management department.
• Train and mentor junior staff on best practices in review and cleaning of clinical data.

Skills on Resume:

• Data Management Oversight (Hard Skills)
• Clinical Trial Coordination (Hard Skills)
• Data Plan Delivery (Hard Skills)
• Data Visualization (Hard Skills)
• Tool Development (Hard Skills)
• Data Flow Execution (Hard Skills)
• Feedback Integration (Soft Skills)
• Team Training (Soft Skills)

Job Summary:

• Assist with all data management responsibilities in support of clinical study teams and as defined in policies and procedures
• Collaborates with Clinical Study Team to create protocol case report forms (CRF)
• Perform User Acceptance Testing (UAT) and assist with Validation of the EDC database
• Assist with development of Data Management Plan (DMP) to define the data collection and processing workflow
• Conduct data processing and review in accordance with the study protocol, DMP, and EDC system instructions
• Generate standard and ad hoc reports of EDC CRF or metric data for study team and management reporting
• Assist with coordination of the development of Case Report Forms or EDC forms with clinical and biostatistics groups
• Train clinical personnel on CRFs and EDC
• Assist with database lock activities to ensure the accuracy and completeness of final clinical trials databases prior to submission to Biostatistics for analyses and submission to the FDA and other regulatory agencies in other countries
• Participate as a clinical study team member and contribute to team deliverables to include site EDC training, and study conduct activities through completion of the study report.
• Perform Quality Control checks for study documents and data output
• Participate in departmental developmental initiatives (e.g. training, SOP development, etc.)

Skills on Resume:

• CRF Development (Hard Skills)
• EDC Validation (Hard Skills)
• Data Management Planning (Hard Skills)
• Data Processing (Hard Skills)
• Report Generation (Hard Skills)
• EDC Training (Soft Skills)
• Database Lock Assistance (Hard Skills)
• Quality Control (Hard Skills)