The senior clinical data coder is primarily responsible for leading and overseeing activities related to the coding of clinical data across multiple ongoing studies. in addition to performing accurate coding tasks, the senior coder takes ownership of the coding module setup, establishes conventions, and drives the prioritization of coding deliverables. this role includes leadership responsibilities and active participation in the design, oversight, and continuous improvement of coding processes. the senior clinical data coder will conduct all activities in alignment with applicable regulatory requirements, industry guidelines, and indero sops, while ensuring sponsor timelines and expectations are consistently met. key responsibilities lead and perform accurate coding of medical terms and medications using meddra, who drug, and internal conventions. oversee the setup of the coding module for assigned studies, ensuring correct configurations and workflows. define, document, and manage coding conventions and ensure consistent application across studies. act as the lead coder, coordinating coding activities across multiple studies simultaneously. manage coding priorities, balancing workload across timelines and studies. develop and maintain coding guidelines and synonym lists. provide input to the coding section of data management plans. oversee and perform dictionary up-versioning and related upgrade activities. validate and test coding setups, programming of coding reports, and related database checks. support data review activities and resolve data clarifications in a timely...
The senior clinical data coder is primarily responsible for leading and overseeing activities related to the coding of clinical data across multiple ongoing studies. in addition to performing accurate coding tasks, the senior coder takes ownership of the coding module setup, establishes conventions, and drives the prioritization of coding deliverables. this role includes leadership responsibilities and active participation in the design, oversight, and continuous improvement of coding processes. the senior clinical data coder will conduct all activities in alignment with applicable regulatory requirements, industry guidelines, and indero sops, while ensuring sponsor timelines and expectations are consistently met. key responsibilities - lead and perform accurate coding of medical terms and medications using meddra, who drug, and internal conventions. - oversee the setup of the coding module for assigned studies, ensuring correct configurations and workflows. - define, document, and manage coding conventions and ensure consistent application across studies. - act as the lead coder, coordinating coding activities across multiple studies simultaneously. - manage coding priorities, balancing workload across timelines and studies. - develop and maintain coding guidelines and synonym lists. - provide input to the coding section of data management plans. - oversee and perform dictionary up-versioning and related upgrade activities. - validate and test coding setups, programming of coding reports, and related database checks. - support data review activities and resolve data clar...
As a clinical data manager ii, you will ensure that data captured in multiple clinical trials undertaken or managed by indero is collected, managed, and reported clearly, accurately and securely. this role will be perfect for you if: you want to work on studies end-to-end (involved from protocol review to database lock) you have the experience and confidence to lead multiple concurrent studies successfully as a data manager you enjoy working directly with clients and forming recommendations as needed responsibilities data management lead monitor study status (ie. enrollment, crfs monitored/approved, etc.) on an ongoing basis present deliverables to clients, gather feedback and propose solutions. provide regular data status reports to the project team oversee work of the clinical data coordinator as required (quality, timeliness) oversee vendors to ensure that timelines and deliverables meet sponsor and protocol requirements is responsible for ongoing maintenance of the clinical database, including data review/cleaning during study conduct and during preparation for database lock/close. conduct reconciliation between external data and data in the edc system to ensure consistency, including reconciliation with sponsor safety databases for adverse events/sae (serious adverse events) data study setup – technical develop the data management plan (dmp) build a study-specific clinical database using the edc system: design the electronic case report form (ecrf) build the clinical database in the chosen edc independently or with the support of an edc programmer (determined based on ...
Join to apply for the clinical data manager ii (colombia) role at indero (formerly innovaderm) 2 days ago be among the first 25 applicants join to apply for the clinical data manager ii (colombia) role at indero (formerly innovaderm) get ai-powered advice on this job and more exclusive features. as a clinical data manager ii, you will ensure that data captured in multiple clinical trials undertaken or managed by indero is collected, managed, and reported clearly, accurately and securely. this role will be perfect for you if: - you want to work on studies end-to-end (involved from protocol review to database lock) - you have the experience and confidence to lead multiple concurrent studies successfully as a data manager - you enjoy working directly with clients and forming recommendations as needed responsibilities data management lead - monitor study status (ie. enrollment, crfs monitored/approved, etc.) on an ongoing basis - present deliverables to clients, gather feedback and propose solutions. - provide regular data status reports to the project team - oversee work of the clinical data coordinator as required (quality, timeliness) - oversee vendors to ensure that timelines and deliverables meet sponsor and protocol requirements - is responsible for ongoing maintenance of the clinical database, including data review/cleaning during study conduct and during preparation for database lock/close. - conduct reconciliation between external data and data in the edc system to ensure consistency, including reconciliation with sponsor safety databases for ad...
Join to apply for the clinical data manager ii (colombia) role at indero (formerly innovaderm) 2 days ago be among the first 25 applicants join to apply for the clinical data manager ii (colombia) role at indero (formerly innovaderm) get ai-powered advice on this job and more exclusive features. as a clinical data manager ii, you will ensure that data captured in multiple clinical trials undertaken or managed by indero is collected, managed, and reported clearly, accurately and securely. this role will be perfect for you if: - you want to work on studies end-to-end (involved from protocol review to database lock) - you have the experience and confidence to lead multiple concurrent studies successfully as a data manager - you enjoy working directly with clients and forming recommendations as needed responsibilities data management lead - monitor study status (ie. enrollment, crfs monitored/approved, etc.) on an ongoing basis - present deliverables to clients, gather feedback and propose solutions. - provide regular data status reports to the project team - oversee work of the clinical data coordinator as required (quality, timeliness) - oversee vendors to ensure that timelines and deliverables meet sponsor and protocol requirements - is responsible for ongoing maintenance of the clinical database, including data review/cleaning during study conduct and during preparation for database lock/close. - conduct reconciliation between external data and data in the edc system to ensure consistency, including reconciliation with sponsor safety databases for adverse even...
Join to apply for the clinical data manager ii (colombia) role at indero (formerly innovaderm) 2 days ago be among the first 25 applicants join to apply for the clinical data manager ii (colombia) role at indero (formerly innovaderm) get ai-powered advice on this job and more exclusive features. as a clinical data manager ii, you will ensure that data captured in multiple clinical trials undertaken or managed by indero is collected, managed, and reported clearly, accurately and securely. this role will be perfect for you if: you want to work on studies end-to-end (involved from protocol review to database lock) you have the experience and confidence to lead multiple concurrent studies successfully as a data manager you enjoy working directly with clients and forming recommendations as needed responsibilities data management lead monitor study status (ie. enrollment, crfs monitored/approved, etc.) on an ongoing basis present deliverables to clients, gather feedback and propose solutions. provide regular data status reports to the project team oversee work of the clinical data coordinator as required (quality, timeliness) oversee vendors to ensure that timelines and deliverables meet sponsor and protocol requirements is responsible for ongoing maintenance of the clinical database, including data review/cleaning during study conduct and during preparation for database lock/close. conduct reconciliation between external data and data in the edc system to ensure consistency, including reconciliation with sponsor safety databases for adverse events/s...
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