- Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts, such as protocol revisions.
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- Gather, analyze, or document user feedback to locate or resolve sources of problems.
- Check and analyze operating system or application log files regularly to verify proper system performance.
- Monitor systems for intrusions or denial of service attacks, and report security breaches to appropriate personnel.
- Identify or document backup or recovery plans.
- Back up or modify applications and related data to provide for disaster recovery.
- Correct testing-identified problems, or recommend actions for their resolution.
- Identify, standardize, and communicate levels of access and security.
- Determine sources of Web page or server problems, and take action to correct such problems.
- Implement updates, upgrades, and patches in a timely manner to limit loss of service.
- Implement Web site security measures, such as firewalls or message encryption.
- Collaborate with development teams to discuss, analyze, or resolve usability issues.
- Test issues such as system integration, performance, and system security on a regular schedule or after any major program modifications.
- Perform user testing or usage analyses to determine Web sites' effectiveness or usability.
- Document application and Web site changes or change procedures.
- Track, compile, and analyze Web site usage data.
- Test backup or recovery plans regularly and resolve any problems.
- Recommend Web site improvements, and develop budgets to support recommendations.
- Review or update Web page content or links in a timely manner, using appropriate tools.
- Install or configure Web server software or hardware to ensure that directory structure is well-defined, logical, and secure, and that files are named properly.
- Set up or maintain monitoring tools on Web servers or Web sites.
- Monitor Web developments through continuing education, reading, or participation in professional conferences, workshops, or groups.
- Develop or document style guidelines for Web site content.
- Develop Web site performance metrics.
- Collaborate with Web developers to create and operate internal and external Web sites, or to manage projects, such as e-marketing campaigns.
- Identify or address interoperability requirements.
- Develop or implement procedures for ongoing Web site revision.
- Provide training or technical assistance in Web site implementation or use.
- Evaluate testing routines or procedures for adequacy, sufficiency, and effectiveness.
- Inform Web site users of problems, problem resolutions, or application changes and updates.
- Document installation or configuration procedures to allow maintenance and repetition.
- Develop testing routines and procedures.
- Test new software packages for use in Web operations or other applications.
- Develop and implement marketing plans for home pages, including print advertising or advertisement rotation.
- Evaluate or recommend server hardware or software.
- Administer internet or intranet infrastructure, including Web, file, and mail servers.
- Gather, analyze, or document user feedback to locate or resolve sources of problems.
- Check and analyze operating system or application log files regularly to verify proper system performance.
- Identify solutions to business problems, such as budgeting, staffing, and marketing decisions, using the results of data analysis.
- Analyze, manipulate, or process large sets of data using statistical software.
- Apply feature selection algorithms to models predicting outcomes of interest, such as sales, attrition, and healthcare use.
- Apply sampling techniques to determine groups to be surveyed or use complete enumeration methods.
- Clean and manipulate raw data using statistical software.
- Compare models using statistical performance metrics, such as loss functions or proportion of explained variance.
- Create graphs, charts, or other visualizations to convey the results of data analysis using specialized software.
- Deliver oral or written presentations of the results of mathematical modeling and data analysis to management or other end users.
- Design surveys, opinion polls, or other instruments to collect data.
- Identify business problems or management objectives that can be addressed through data analysis.
- Identify relationships and trends or any factors that could affect the results of research.
- Propose solutions in engineering, the sciences, and other fields using mathematical theories and techniques.
- Read scientific articles, conference papers, or other sources of research to identify emerging analytic trends and technologies.
- Recommend data-driven solutions to key stakeholders.
- Test, validate, and reformulate models to ensure accurate prediction of outcomes of interest.
- Write new functions or applications in programming languages to conduct analyses.
- Identify solutions to business problems, such as budgeting, staffing, and marketing decisions, using the results of data analysis.
- Analyze, manipulate, or process large sets of data using statistical software.
- Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts, such as protocol revisions.
- Code, evaluate, or interpret collected study data.
- Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.
- Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms.
- Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, or discussions with physicians and nurses.
- Prepare study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
- Inform patients or caregivers about study aspects and outcomes to be expected.
- Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
- Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
- Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
- Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.
- Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, or potential subject risks.
- Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
- Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
- Direct the requisition, collection, labeling, storage, or shipment of specimens.
- Instruct research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.
- Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
- Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
- Order drugs or devices necessary for study completion.
- Contact outside health care providers and communicate with subjects to obtain follow-up information.
- Participate in the development of study protocols including guidelines for administration or data collection procedures.
- Confer with health care professionals to determine the best recruitment practices for studies.
- Communicate with laboratories or investigators regarding laboratory findings.
- Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.
- Organize space for study equipment and supplies.
- Develop advertising and other informational materials to be used in subject recruitment.
- Dispense medical devices or drugs, and calculate dosages and provide instructions as necessary.
- Arrange for research study sites and determine staff or equipment availability.
- Interpret protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.
- Contact industry representatives to ensure equipment and software specifications necessary for successful study completion.
- Register protocol patients with appropriate statistical centers as required.
- Solicit industry-sponsored trials through contacts and professional organizations.
- Participate in preparation and management of research budgets and monetary disbursements.
- Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts, such as protocol revisions.
- Code, evaluate, or interpret collected study data.
- Analyze problems to develop solutions involving computer hardware and software.
- Apply theoretical expertise and innovation to create or apply new technology, such as adapting principles for applying computers to new uses.
- Assign or schedule tasks to meet work priorities and goals.
- Meet with managers, vendors, and others to solicit cooperation and resolve problems.
- Design computers and the software that runs them.
- Conduct logical analyses of business, scientific, engineering, and other technical problems, formulating mathematical models of problems for solution by computers.
- Evaluate project plans and proposals to assess feasibility issues.
- Participate in multidisciplinary projects in areas such as virtual reality, human-computer interaction, or robotics.
- Consult with users, management, vendors, and technicians to determine computing needs and system requirements.
- Develop and interpret organizational goals, policies, and procedures.
- Develop performance standards, and evaluate work in light of established standards.
- Maintain network hardware and software, direct network security measures, and monitor networks to ensure availability to system users.
- Direct daily operations of departments, coordinating project activities with other departments.
- Participate in staffing decisions and direct training of subordinates.
- Approve, prepare, monitor, and adjust operational budgets.
- Analyze problems to develop solutions involving computer hardware and software.
- Analyze information obtained from management to conceptualize and define operational problems.
- Present the results of mathematical modeling and data analysis to management or other end users.
- Define data requirements, and gather and validate information, applying judgment and statistical tests.
- Perform validation and testing of models to ensure adequacy, and reformulate models, as necessary.
- Prepare management reports defining and evaluating problems and recommending solutions.
- Collaborate with others in the organization to ensure successful implementation of chosen problem solutions.
- Formulate mathematical or simulation models of problems, relating constants and variables, restrictions, alternatives, conflicting objectives, and their numerical parameters.
- Observe the current system in operation, and gather and analyze information about each of the component problems, using a variety of sources.
- Study and analyze information about alternative courses of action to determine which plan will offer the best outcomes.
- Collaborate with senior managers and decision makers to identify and solve a variety of problems and to clarify management objectives.
- Specify manipulative or computational methods to be applied to models.
- Design, conduct, and evaluate experimental operational models in cases where models cannot be developed from existing data.
- Develop and apply time and cost networks to plan, control, and review large projects.
- Break systems into their components, assign numerical values to each component, and examine the mathematical relationships between them.
- Educate staff in the use of mathematical models.
- Develop business methods and procedures, including accounting systems, file systems, office systems, logistics systems, and production schedules.
- Review research literature.
- Analyze information obtained from management to conceptualize and define operational problems.
- Analyze equipment performance records to determine the need for repair or replacement.
- Maintain and administer computer networks and related computing environments, including computer hardware, systems software, applications software, and all configurations.
- Perform data backups and disaster recovery operations.
- Diagnose, troubleshoot, and resolve hardware, software, or other network and system problems, and replace defective components when necessary.
- Configure, monitor, and maintain email applications or virus protection software.
- Operate master consoles to monitor the performance of computer systems and networks and to coordinate computer network access and use.
- Monitor network performance to determine whether adjustments are needed and where changes will be needed in the future.
- Plan, coordinate, and implement network security measures to protect data, software, and hardware.
- Confer with network users about solutions to existing system problems.
- Recommend changes to improve systems and network configurations, and determine hardware or software requirements related to such changes.
- Design, configure, and test computer hardware, networking software and operating system software.
- Perform routine network startup and shutdown procedures, and maintain control records.
- Load computer tapes and disks, and install software and printer paper or forms.
- Train people in computer system use.
- Maintain logs related to network functions, as well as maintenance and repair records.
- Gather data pertaining to customer needs, and use the information to identify, predict, interpret, and evaluate system and network requirements.
- Coordinate with vendors and with company personnel to facilitate purchases.
- Implement and provide technical support for voice services and equipment, such as private branch exchange, voice mail system, and telecom system.
- Maintain an inventory of parts for emergency repairs.
- Research new technologies by attending seminars, reading trade articles, or taking classes, and implement or recommend the implementation of new technologies.
- Analyze equipment performance records to determine the need for repair or replacement.
- Generate data queries, based on validation checks or errors and omissions identified during data entry, to resolve identified problems.
- Design and validate clinical databases, including designing or testing logic checks.
- Process clinical data, including receipt, entry, verification, or filing of information.
- Develop project-specific data management plans that address areas such as coding, reporting, or transfer of data, database locks, and work flow processes.
- Monitor work productivity or quality to ensure compliance with standard operating procedures.
- Prepare appropriate formatting to data sets as requested.
- Design forms for receiving, processing, or tracking data.
- Prepare data analysis listings and activity, performance, or progress reports.
- Confer with end users to define or implement clinical system requirements such as data release formats, delivery schedules, and testing protocols.
- Perform quality control audits to ensure accuracy, completeness, or proper usage of clinical systems and data.
- Analyze clinical data using appropriate statistical tools.
- Evaluate processes and technologies, and suggest revisions to increase productivity and efficiency.
- Develop technical specifications for data management programming and communicate needs to information technology staff.
- Write work instruction manuals, data capture guidelines, or standard operating procedures.
- Track the flow of work forms, including in-house data flow or electronic forms transfer.
- Supervise the work of data management project staff.
- Contribute to the compilation, organization, and production of protocols, clinical study reports, regulatory submissions, or other controlled documentation.
- Read technical literature and participate in continuing education or professional associations to maintain awareness of current database technology and best practices.
- Train staff on technical procedures or software program usage.
- Develop or select specific software programs for various research scenarios.
- Provide support and information to functional areas such as marketing, clinical monitoring, and medical affairs.
- Generate data queries, based on validation checks or errors and omissions identified during data entry, to resolve identified problems.
- Review and analyze computer printouts and performance indicators to locate code problems, and correct errors by correcting codes.
- Troubleshoot program and system malfunctions to restore normal functioning.
- Provide staff and users with assistance solving computer-related problems, such as malfunctions and program problems.
- Test, maintain, and monitor computer programs and systems, including coordinating the installation of computer programs and systems.
- Use the computer in the analysis and solution of business problems, such as development of integrated production and inventory control and cost analysis systems.
- Coordinate and link the computer systems within an organization to increase compatibility so that information can be shared.
- Use object-oriented programming languages, as well as client and server applications development processes and multimedia and Internet technology.
- Analyze information processing or computation needs and plan and design computer systems, using techniques such as structured analysis, data modeling, and information engineering.
- Consult with management to ensure agreement on system principles.
- Specify inputs accessed by the system and plan the distribution and use of the results.
- Expand or modify system to serve new purposes or improve work flow.
- Train staff and users to work with computer systems and programs.
- Assess the usefulness of pre-developed application packages and adapt them to a user environment.
- Determine computer software or hardware needed to set up or alter systems.
- Read manuals, periodicals, and technical reports to learn how to develop programs that meet staff and user requirements.
- Develop, document, and revise system design procedures, test procedures, and quality standards.
- Recommend new equipment or software packages.
- Define the goals of the system and devise flow charts and diagrams describing logical operational steps of programs.
- Confer with clients regarding the nature of the information processing or computation needs a computer program is to address.
- Interview or survey workers, observe job performance, or perform the job to determine what information is processed and how it is processed.
- Supervise computer programmers or other systems analysts or serve as project leaders for particular systems projects.
- Prepare cost-benefit and return-on-investment analyses to aid in decisions on system implementation.
- Review and analyze computer printouts and performance indicators to locate code problems, and correct errors by correcting codes.
- Analyze, interpret, or disseminate system performance data.
- Assist in determining document management policies to facilitate efficient, legal, and secure access to electronic content.
- Assist in the development of document or content classification taxonomies to facilitate information capture, search, and retrieval.
- Implement electronic document processing, retrieval, and distribution systems in collaboration with other information technology specialists.
- Identify and classify documents or other electronic content according to characteristics such as security level, function, and metadata.
- Develop, document, or maintain standards, best practices, or system usage procedures.
- Assist in the assessment, acquisition, or deployment of new electronic document management systems.
- Administer document and system access rights and revision control to ensure security of system and integrity of master documents.
- Prepare and record changes to official documents and confirm changes with legal and compliance management staff, including enterprise-wide records management staff.
- Write, review, or execute plans for testing new or established document management systems.
- Monitor regulatory activity to maintain compliance with records and document management laws.
- Retrieve electronic assets from repository for distribution to users, collecting and returning to repository, if necessary.
- Keep abreast of developments in document management technologies and techniques by reviewing current literature, talking with colleagues, participating in educational programs, attending meetings or workshops, or participating in professional organizations or conferences.
- Conduct needs assessments to identify document management requirements of departments or end users.
- Develop or configure document management system features, such as user interfaces, access profiles, and document workflow procedures.
- Document technical functions and specifications for new or proposed content management systems.
- Exercise security surveillance over document processing, reproduction, distribution, storage, or archiving.
- Consult with end users regarding problems in accessing electronic content.
- Propose recommendations for improving content management system capabilities.
- Operate data capture technology to import digitized documents into document management system.
- Prepare support documentation and training materials for end users of document management systems.
- Search electronic sources, such as databases or repositories, or manual sources for information.
- Implement scanning or other automated data entry procedures, using imaging devices and document imaging software.
- Analyze, interpret, or disseminate system performance data.
- Analyze network data to determine network usage, disk space availability, or server function.
- Back up network data.
- Configure security settings or access permissions for groups or individuals.
- Analyze and report computer network security breaches or attempted breaches.
- Identify the causes of networking problems, using diagnostic testing software and equipment.
- Document network support activities.
- Configure wide area network (WAN) or local area network (LAN) routers or related equipment.
- Install network software, including security or firewall software.
- Troubleshoot network or connectivity problems for users or user groups.
- Provide telephone support related to networking or connectivity issues.
- Evaluate local area network (LAN) or wide area network (WAN) performance data to ensure sufficient availability or speed, to identify network problems, or for disaster recovery purposes.
- Perform routine maintenance or standard repairs to networking components or equipment.
- Configure and define parameters for installation or testing of local area network (LAN), wide area network (WAN), hubs, routers, switches, controllers, multiplexers, or related networking equipment.
- Install new hardware or software systems or components, ensuring integration with existing network systems.
- Test computer software or hardware, using standard diagnostic testing equipment and procedures.
- Install or repair network cables, including fiber optic cables.
- Monitor industry Web sites or publications for information about patches, releases, viruses, or potential problem identification.
- Create or update technical documentation for network installations or changes to existing installations.
- Train users in procedures related to network applications software or related systems.
- Test repaired items to ensure proper operation.
- Install and configure wireless networking equipment.
- Maintain logs of network activity.
- Document help desk requests and resolutions.
- Research hardware or software products to meet technical networking or security needs.
- Create or revise user instructions, procedures, or manuals.
- Run monthly network reports.
- Analyze network data to determine network usage, disk space availability, or server function.
- Recommend adjudication of product complaints.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Coordinate recall or market withdrawal activities as necessary.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- Identify relevant guidance documents, international standards, or consensus standards.
- Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
- Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Recommend changes to company procedures in response to changes in regulations or standards.
- Participate in internal or external audits.
- Compile and maintain regulatory documentation databases or systems.
- Write or update standard operating procedures, work instructions, or policies.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
- Develop or track quality metrics.
- Develop or conduct employee regulatory training.
- Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
- Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
- Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
- Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
- Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
- Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.
- Recommend adjudication of product complaints.
- Identify, analyze, and document problems with program function, output, online screen, or content.
- Document software defects, using a bug tracking system, and report defects to software developers.
- Develop testing programs that address areas such as database impacts, software scenarios, regression testing, negative testing, error or bug retests, or usability.
- Design test plans, scenarios, scripts, or procedures.
- Document test procedures to ensure replicability and compliance with standards.
- Provide feedback and recommendations to developers on software usability and functionality.
- Install, maintain, or use software testing programs.
- Test system modifications to prepare for implementation.
- Create or maintain databases of known test defects.
- Develop or specify standards, methods, or procedures to determine product quality or release readiness.
- Monitor bug resolution efforts and track successes.
- Update automated test scripts to ensure currency.
- Participate in product design reviews to provide input on functional requirements, product designs, schedules, or potential problems.
- Plan test schedules or strategies in accordance with project scope or delivery dates.
- Monitor program performance to ensure efficient and problem-free operations.
- Conduct software compatibility tests with programs, hardware, operating systems, or network environments.
- Investigate customer problems referred by technical support.
- Review software documentation to ensure technical accuracy, compliance, or completeness, or to mitigate risks.
- Identify program deviance from standards, and suggest modifications to ensure compliance.
- Perform initial debugging procedures by reviewing configuration files, logs, or code pieces to determine breakdown source.
- Design or develop automated testing tools.
- Install and configure recreations of software production environments to allow testing of software performance.
- Collaborate with field staff or customers to evaluate or diagnose problems and recommend possible solutions.
- Coordinate user or third-party testing.
- Visit beta testing sites to evaluate software performance.
- Conduct historical analyses of test results.
- Evaluate or recommend software for testing or bug tracking.
- Modify existing software to correct errors, allow it to adapt to new hardware, or to improve its performance.
- Recommend purchase of equipment to control dust, temperature, or humidity in area of system installation.
- Store, retrieve, and manipulate data for analysis of system capabilities and requirements.
- Identify, analyze, and document problems with program function, output, online screen, or content.
- Monitor and analyze network performance and reports on data input or output to detect problems, identify inefficient use of computer resources, or perform capacity planning.
- Develop disaster recovery plans.
- Develop or recommend network security measures, such as firewalls, network security audits, or automated security probes.
- Develop and implement solutions for network problems.
- Maintain networks by performing activities such as file addition, deletion, or backup.
- Coordinate network operations, maintenance, repairs, or upgrades.
- Coordinate installation of new equipment.
- Develop network-related documentation.
- Develop and write procedures for installation, use, or troubleshooting of communications hardware or software.
- Participate in network technology upgrade or expansion projects, including installation of hardware and software and integration testing.
- Design, build, or operate equipment configuration prototypes, including network hardware, software, servers, or server operation systems.
- Adjust network sizes to meet volume or capacity demands.
- Communicate with system users to ensure accounts are set up properly or to diagnose and solve operational problems.
- Develop conceptual, logical, or physical network designs.
- Evaluate network designs to determine whether customer requirements are met efficiently and effectively.
- Communicate with vendors to gather information about products, alert them to future needs, resolve problems, or address system maintenance issues.
- Develop plans or budgets for network equipment replacement.
- Communicate with customers, sales staff, or marketing staff to determine customer needs.
- Determine specific network hardware or software requirements, such as platforms, interfaces, bandwidths, or routine schemas.
- Prepare detailed network specifications, including diagrams, charts, equipment configurations, or recommended technologies.
- Supervise engineers or other staff in the design or implementation of network solutions.
- Research and test new or modified hardware or software products to determine performance and interoperability.
- Estimate time and materials needed to complete projects.
- Design, organize, and deliver product awareness, skills transfer, or product education sessions for staff or suppliers.
- Explain design specifications to integration or test engineers.
- Develop procedures to track, project, or report network availability, reliability, capacity, or utilization.
- Coordinate network or design activities with designers of associated networks.
- Prepare or monitor project schedules, budgets, or cost control systems.
- Prepare design presentations and proposals for staff or customers.
- Use network computer-aided design (CAD) software packages to optimize network designs.
- Visit vendors, attend conferences or training sessions, or study technical journals to keep up with changes in technology.
- Develop or maintain project reporting systems.
- Maintain or coordinate the maintenance of network peripherals, such as printers.
- Monitor and analyze network performance and reports on data input or output to detect problems, identify inefficient use of computer resources, or perform capacity planning.