- Trivandrum
- 0 - 0 Years
- Not disclosed
- Senior Clinical Data Coordinator
- Today
Job Description
Assist in the development of edit specifications, based on any available global medical standards, therapeutic area standards, and the protocol, used to clean the study.? Performs user acceptance testing (UAT) on eCRF build and edit specifications.? Creates supporting DM process documentation to LDM and/or performs peer review of documentation, including updating documentation.? Support the coding schedule defined in the data management plan.?Collaborate with data coding specialists on a regular basis to guarantee timely coding.? Supports/maintains quarterly coding review cycles.? Performs manual data listing reviews and submits queries as?appropriate. Assist with and/or performs user acceptance testing of lab data?standards. Evaluates quality of lab data entry and addresses inconsistencies with sites and CRAs as applicable.? Assists in the SAE reconciliation process. This may include coordination with medical experts and Global Drug Safety.?Follow up on discrepancies and resolve so both databases are consistent.? Applies criteria for subject stage gate of No More Issues (NMI).?Also, must coordinate and review medical and statistical queries and certify they are adequately resolved.? Assist in the development of a blind review report and conducting a blind review meeting to assign patient validity.? Assist in developing and generating study report listings according to ICH and if present company guidelines.? Coordinate the query management system functions.? Perform the final patient review and database lock activities. Assist in coordinating the processing of scheduled data transfers (PK/PD data, imaging data, Laboratory data) from external vendors and performs relevant review/reconciliation.? Review query responses and ensure data quality.? Reviews Site responses to queries and evaluates the necessity of a re-query. If applicable, communications with Site Coordinators are performed for resolution.? Attends and may lead internal and external team meetings.? Reviews and/or provides meeting minutes.? Supports training and development of Clinical Data Coordinators. Assists with eCRF design. May be required to develop the eCRF and/or provide peer review. May serve as a back up to the LDM for internal and external study teams.Skills
Assist in the development of edit specifications, based on any available global medical standards, therapeutic area standards, and the protocol, used to clean the study.? Performs user acceptance testing (UAT) on eCRF build and edit specifications.? Creates supporting DM process documentation to LDM and/or performs peer review of documentation, including updating documentation.? Support the coding schedule defined in the data management plan.?Collaborate with data coding specialists on a regular basis to guarantee timely coding.? Supports/maintains quarterly coding review cycles.? Performs manual data listing reviews and submits queries as?appropriate. Assist with and/or performs user acceptance testing of lab data?standards. Evaluates quality of lab data entry and addresses inconsistencies with sites and CRAs as applicable.? Assists in the SAE reconciliation process. This may include coordination with medical experts and Global Drug Safety.?Follow up on discrepancies and resolve so both databases are consistent.? Applies criteria for subject stage gate of No More Issues (NMI).?Also, must coordinate and review medical and statistical queries and certify they are adequately resolved.? Assist in the development of a blind review report and conducting a blind review meeting to assign patient validity.? Assist in developing and generating study report listings according to ICH and if present company guidelines.? Coordinate the query management system functions.? Perform the final patient review and database lock activities. Assist in coordinating the processing of scheduled data transfers (PK/PD data, imaging data, Laboratory data) from external vendors and performs relevant review/reconciliation.? Review query responses and ensure data quality.? Reviews Site responses to queries and evaluates the necessity of a re-query. If applicable, communications with Site Coordinators are performed for resolution.? Attends and may lead internal and external team meetings.? Reviews and/or provides meeting minutes.? Supports training and development of Clinical Data Coordinators. Assists with eCRF design. May be required to develop the eCRF and/or provide peer review. May serve as a back up to the LDM for internal and external study teams.Suggested Jobs
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