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• Recognize, exemplify and adhere to ICON’s values which center around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• * Travel (approximately 15%) domestic and/or international.
CDMS:
• * Serves as the lead on study specific database design within the CDMS system (i.e. Oracle RDC, Oracle Inform, Medidata Rave, DataTrak UX EDC, Oracle Clinical and CRF WorkManager), leading clinical database programming activities on multiple studies of complex design and expert in all areas for relevant CDMS.
• *Reviews database specification documents created by study teams, such as CRF Specifications and Data Validation Specifications (DVS).
• *Builds clinical study database CRF screens per CRF Specifications provided by project team.
• *Creates/Programs edit checks, special actions/functions , custom programs and derivations as per a DVS.
• *Plans and schedules edit check test script writing , edit check programming and edit check validation with the centralized CDMS Testing group and centralized CDMS Programming group. Manages timelines for edit check process, ensures issues are addressed in a timely manner to meet timelines and produces edit check validation packages for delivery to the study teams to file in the Trial Master File.
• *Completes study database updates as specified per Change Request documents and procedures. Performs an Impact Analysis and Risk Assessment of the proposed changes
• *Configures study specific data interfaces such as IVRS, labs, and CTMS.
• *Serves on project teams to coordinate and lead CDMS activities for clinical database programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive criticism . Keeps those responsible for project management informed of any issues that might impact project target dates, scope or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources.
• *Trouble-shoots and solves study building issues and/or system integration issues (such as IVRS failures , CTMS issues), and/or change request issues using the appropriate applications.
• Creates advanced CDMS custom programs as per DVS, as required.
• May participate in study team meetings as an ad hoc study team member to advise study team on best approach/tool for data collection, to determine scope and limitations of the study and to discuss edit checks, derivations , testing and reports.
• Ensures high quality deliverables by providing senior review of study-level/program -level I multi study core deliveries for accuracy.
• Participates in special projects or tasks related to the assigned CDMS as directed by the CDMS Manager, as required. This can involve taking ownership of planning, maintenance and delivery of special projects while keeping management informed of the progress.
• Attends sponsor audits and assists with in- ro ress audits , includin the CDMS prrocess and procedures and presenting the validation documentation produced by the CDMS group.
• *Maintain confidentiality of management information as appropriate.
• To participate and contribute towards internal user group meetings to share knowledge and providing latest updates/features. Participate in Data Management department initiatives.
• Plan for the study execution in detail thereby providing clarity on all aspects of the setup progress (Round 1 programming date, testing dates, UAT dates)
• To act as a bridge between the Clinical Data Programmers and Validation Group within CDMS. Addressing technical clarifications and providing guidance as needed.
• Maintaining all necessary study documentation for the CRF build and edit checks.
• Keeps up-to-date with all software developments and release notes of assigned primary CDMS system. Research and self-training is required to ensure that CDMS knowledge, particularly in relation to system functionality, is current.
• Ensures all queries to the CDMS group are responded to in a timely manner, particularly when trouble-shooting an issue or answering a system functionality question. Ensures that queries that cannot be resolved are routed to the correct SME and the issue is pursued until resolved.
• Contributes to training materials on a process, system or technology level. Works with ICON University and DM Management on delivery of training courses, instructor-led and on-the-job.
• Ensures programming processes are compliant with applicable SOPs.
• Respond to Business Development requests as required
• Administrative responsibilities include projecting the planning and tracking of projects, resource allocation, and supervision of programmers, medical terminologists, and/or forms designers.
• Participates in task assignment activities where required and acts as a back-up in CDMS Manager’s absence
• Ability to retrieve raw datasets.
• Other responsibilities may be assigned as required.
• CDS:
• * Serves as the clinical data delivery lead on multiple study specific programming setup, leading clinical data programming activities on multiple studies of complex design, with expert clinical data delivery experience and knowledge.
• * Reviews specification documents created by study teams, such as data transformation specifications and programming specifications.
• * Quality assures programming outputs and support validation activities per the formal, documented QC process.
• * Plans and works with the clinical programming group to schedule specification, programming, validation and ongoing delivery activities. Manages timelines for programming setup process, ensures issues are addressed in a timely manner to meet timelines and produces clinical data delivery validation packages for delivery to the study teams to file in the Trial Master File.
• * Co-ordinates and manages study database updates and out of scope impacts as specified per Change Request documents and procedures. Performs an Impact Analysis and Risk Assessment of the proposed changes.
• * Serves on project teams to coordinate and lead development activities for multiple clinical data programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive criticism. Keeps those responsible for project management informed of any issues that might impact project target dates, scope or budqet and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources.
• * May participate in study team meetings as an ad hoc study team member to advise study team on best approach/tool for data delivery, to determine scope and limitations of the study and to discuss opportunities for innovative clinical data delivery .
• Trouble-shoo ts and solves study data delivery issues and/or external data integration issues and/or change request issues using the appropriate applications.
• Ensures high quality deliverables by providing senior review of study-level/program-level/multi-study core deliveries for accuracy.
• Participates in special projects or tasks related to the clinical data delivery as directed by the Clinical Data Delivery Manager, as required. This can involve taking ownership of planning, maintenance and delivery of special projects while keeping management informed of the progress.
• Attends sponsor audits and assists with in-progress audits, including presenting the Clinical Data Delivery process and procedures and pretending the validation documentation produced by the Clinical Data Service Group.
• *Maintain confidentiality of management information as appropriate .
• To participate and contribute towards internal user group meetings to share knowledge and providing latest updates/features . Participates in Data Management department initiatives.
• Plan for the study clinical data delivery in detail thereby providing clarity on all aspects of the setup progress.
• Maintaining all necessary study documentation for the clinical data delivery .
• Ensures all clinical data delivery queries are responded to in a timely manner. Ensures that queries that cannot be resolved are routed to the correct SME and the issue is perused until resolved.
• Contributes to training materials on a process, system or technology level. Works with ICON University and OM Management on delivery of training courses, instructor-led and on-the-job .
• Ensures programming processes are compliant with applicable SOPs.
• Respond to Business Development requests as required
• Administrative responsibilities include projecting the planning and tracking of projects, resource allocation, and revenue allocation and forecast.
• Participates in task assignment activities where required and acts as a back-up in the Clinical Data Delivery Manager’s absence
• Other responsibilities may be assigned as required.
