- Contribute to the compilation, organization, and production of protocols, clinical study reports, regulatory submissions, or other controlled documentation.
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- Contribute to the compilation, organization, and production of protocols, clinical study reports, regulatory submissions, or other controlled documentation.
- Design and validate clinical databases, including designing or testing logic checks.
- Process clinical data, including receipt, entry, verification, or filing of information.
- Generate data queries, based on validation checks or errors and omissions identified during data entry, to resolve identified problems.
- 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.
- Supervise the work of data management project staff.
- 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.
- Track the flow of work forms, including in-house data flow or electronic forms transfer.
- Contribute to the compilation, organization, and production of protocols, clinical study reports, regulatory submissions, or other controlled documentation.
- Prepare and record changes to official documents and confirm changes with legal and compliance management staff, including enterprise-wide records management staff.
- 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.
- Administer document and system access rights and revision control to ensure security of system and integrity of master documents.
- 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.
- Assist in the assessment, acquisition, or deployment of new electronic document management systems.
- Prepare and record changes to official documents and confirm changes with legal and compliance management staff, including enterprise-wide records management staff.
- Create and manage documentation, production schedules, prototyping goals, and communication plans in collaboration with production staff.
- Balance and adjust gameplay experiences to ensure the critical and commercial success of the product.
- Devise missions, challenges, or puzzles to be encountered in game play.
- Create core game features, including storylines, role-play mechanics, and character biographies for a new video game or game franchise.
- Solicit, obtain, and integrate feedback from design and technical staff into original game design.
- Conduct regular design reviews throughout the game development process.
- Develop and maintain design level documentation, including mechanics, guidelines, and mission outlines.
- Document all aspects of formal game design, using mock-up screenshots, sample menu layouts, gameplay flowcharts, and other graphical devices.
- Provide feedback to designers and other colleagues regarding game design features.
- Provide feedback to production staff regarding technical game qualities or adherence to original design.
- Create gameplay prototypes for presentation to creative and technical staff and management.
- Guide design discussions between development teams.
- Oversee gameplay testing to ensure intended gaming experience and game adherence to original vision.
- Present new game design concepts to management and technical colleagues, including artists, animators, and programmers.
- Prepare two-dimensional concept layouts or three-dimensional mock-ups.
- Keep abreast of game design technology and techniques, industry trends, or audience interests, reactions, and needs by reviewing current literature, talking with colleagues, participating in educational programs, attending meetings or workshops, or participating in professional organizations or conferences.
- Review or evaluate competitive products, film, music, television, and other art forms to generate new game design ideas.
- Collaborate with artists to achieve appropriate visual style.
- Write or supervise the writing of game text and dialogue.
- Consult with multiple stakeholders to define requirements and implement online features.
- Determine supplementary virtual features, such as currency, item catalog, menu design, and audio direction.
- Prepare and revise initial game sketches using two- and three-dimensional graphical design software.
- Create gameplay test plans for internal and external test groups.
- Provide test specifications to quality assurance staff.
- Create and manage documentation, production schedules, prototyping goals, and communication plans in collaboration with production staff.
- Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
- Provide responses to regulatory agencies regarding product information or issues.
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Manage activities such as audits, regulatory agency inspections, or product recalls.
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Maintain current knowledge of relevant regulations, including proposed and final rules.
- Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
- Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
- Train staff in regulatory policies or procedures.
- Develop and maintain standard operating procedures or local working practices.
- Participate in the development or implementation of clinical trial protocols.
- Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
- Contribute to the development or implementation of business unit strategic and operating plans.
- Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.
- Coordinate internal discoveries and depositions with legal department staff.
- Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
- Establish regulatory priorities or budgets and allocate resources and workloads.
- Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.
- Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.
- Monitor regulatory affairs trends related to environmental issues.
- Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.
- Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
- Review software documentation to ensure technical accuracy, compliance, or completeness, or to mitigate risks.
- 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.
- 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.
- Review software documentation to ensure technical accuracy, compliance, or completeness, or to mitigate risks.
- Develop or maintain project reporting systems.
- Develop or recommend network security measures, such as firewalls, network security audits, or automated security probes.
- Develop disaster recovery plans.
- 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.
- Coordinate network or design activities with designers of associated networks.
- Develop conceptual, logical, or physical network designs.
- Develop and implement solutions for network problems.
- Determine specific network hardware or software requirements, such as platforms, interfaces, bandwidths, or routine schemas.
- Communicate with system users to ensure accounts are set up properly or to diagnose and solve operational problems.
- Visit vendors, attend conferences or training sessions, or study technical journals to keep up with changes in technology.
- Evaluate network designs to determine whether customer requirements are met efficiently and effectively.
- Participate in network technology upgrade or expansion projects, including installation of hardware and software and integration testing.
- Adjust network sizes to meet volume or capacity demands.
- Prepare detailed network specifications, including diagrams, charts, equipment configurations, or recommended technologies.
- Develop network-related documentation.
- Estimate time and materials needed to complete projects.
- Supervise engineers or other staff in the design or implementation of network solutions.
- Coordinate network operations, maintenance, repairs, or upgrades.
- Develop procedures to track, project, or report network availability, reliability, capacity, or utilization.
- Research and test new or modified hardware or software products to determine performance and interoperability.
- Communicate with customers, sales staff, or marketing staff to determine customer needs.
- Prepare design presentations and proposals for staff or customers.
- Design, build, or operate equipment configuration prototypes, including network hardware, software, servers, or server operation systems.
- Prepare or monitor project schedules, budgets, or cost control systems.
- Develop plans or budgets for network equipment replacement.
- Coordinate installation of new equipment.
- Explain design specifications to integration or test engineers.
- Use network computer-aided design (CAD) software packages to optimize network designs.
- Maintain or coordinate the maintenance of network peripherals, such as printers.
- Develop and write procedures for installation, use, or troubleshooting of communications hardware or software.
- Communicate with vendors to gather information about products, alert them to future needs, resolve problems, or address system maintenance issues.
- Maintain networks by performing activities such as file addition, deletion, or backup.
- Design, organize, and deliver product awareness, skills transfer, or product education sessions for staff or suppliers.
- Develop or maintain project reporting systems.
