Clinical Data Manager Job Vacancies in Hyderabad

Organizing Kick-off meetings with the client co-ordination with the functional Head. Responsible for allocating the project/Study to team members. Responsible for Review and Internal approval of Data Management Plan (DMP), Case Report Form (CRF), and Edit check Specification Document (ESD). Responsible for Review and Internal approval of Data Entry Guidelines, Self-Evident Correction Document (SEC). Internal approval of Annotated CRF (aCRF) and Functional Design Specification (FDS) Document. Responsible for preparing and training the SOPs. Responsible for approval of database screens, Edit checks designed in database and DCF/Query tracker. Internal Quality Control for all Data Management Documents like Data Management Plan, Annotated CRF, Functional Design Specification Document, and Edit check Specification Document. Responsible for Issuing the Database Test Certificate. Responsible for Database Lock and Unlock procedures. Responsible for exporting the data to SAS team for analysis. Responsible for Review and approval of Master Data Management File (MDMF). Responsible for Data Management Presentation in Investigator meeting. Providing inputs for proposal development in co-ordination with the Function Head.

Essential Functions Review and assure the quality, integrity, accuracy, and completeness of clinical trial data based on project specific guidelines. Develop and maintain a library of effective data quality checks. Review data exports and reports to identify, investigate, and reconcile data discrepancies with Clinical Operations staff and/or clients Data Managers. Prepare, review, and upload appropriate Data Management documents to the Trial Master File Perform thorough development testing of the datasets prior to release to production, inclusive of creating test scripts and execute testing as applicable. Author Data Transfer specifications (DTS) for incoming and outgoing data files. Collaborate effectively and build productive relationships across the global operations team. Performs other job-related duties as assignedQualifications 3+ years of data management experience in the clinical trials industry BS/BA degree or professional experience equivalent. Demonstrated successful experience in all relevant clinical data management activities in a Pharmaceutical or CRO setting. Working knowledge of clinical trial research, including FDA, GCP/ICH guidelines, GDPR, CDISC/SDTM standards and 21 CFR Part 11 Experience working with EDC systems, e.g., Medidata Rave or Oracle Inform Familiarity with industry wide coding dictionaries such as MedDRA is a plus Experience with relational databases and XML a plus Excellent written and oral communication skills. Excellent analytical and problem-solving skills Ability to function independently. Ability to prioritize and handle multiple tasks and projects concurrently

Organizing Kick-off meetings with the client co-ordination with the functional Head. Responsible for allocating the project/Study to team members. Responsible for Review and Internal approval of Data Management Plan (DMP), Case Report Form (CRF), and Edit check Specification Document (ESD). Responsible for Review and Internal approval of Data Entry Guidelines, Self-Evident Correction Document (SEC). Internal approval of Annotated CRF (aCRF) and Functional Design Specification (FDS) Document. Responsible for preparing and training the SOPs. Responsible for approval of database screens, Edit checks designed in database and DCF/Query tracker. Internal Quality Control for all Data Management Documents like Data Management Plan, Annotated CRF, Functional Design Specification Document, and Edit check Specification Document. Responsible for Issuing the Database Test Certificate. Responsible for Database Lock and Unlock procedures. Responsible for exporting the data to SAS team for analysis. Responsible for Review and approval of Master Data Management File (MDMF). Responsible for Data Management Presentation in Investigator meeting. Providing inputs for proposal development in co-ordination with the Function Head.

Organizing Kick-off meetings with the client co-ordination with the functional Head. Responsible for allocating the project/Study to team members. Responsible for Review and Internal approval of Data Management Plan (DMP), Case Report Form (CRF), and Edit check Specification Document (ESD). Responsible for Review and Internal approval of Data Entry Guidelines, Self-Evident Correction Document (SEC). Internal approval of Annotated CRF (aCRF) and Functional Design Specification (FDS) Document. Responsible for preparing and training the SOPs. Responsible for approval of database screens, Edit checks designed in database and DCF/Query tracker. Internal Quality Control for all Data Management Documents like Data Management Plan, Annotated CRF, Functional Design Specification Document, and Edit check Specification Document. Responsible for Issuing the Database Test Certificate. Responsible for Database Lock and Unlock procedures. Responsible for exporting the data to SAS team for analysis. Responsible for Review and approval of Master Data Management File (MDMF). Responsible for Data Management Presentation in Investigator meeting. Providing inputs for proposal development in co-ordination with the Function Head.

Organizing Kick-off meetings with the client co-ordination with the functional Head. Responsible for allocating the project/Study to team members. Responsible for Review and Internal approval of Data Management Plan (DMP), Case Report Form (CRF), and Edit check Specification Document (ESD). Responsible for Review and Internal approval of Data Entry Guidelines, Self-Evident Correction Document (SEC). Internal approval of Annotated CRF (aCRF) and Functional Design Specification (FDS) Document. Responsible for preparing and training the SOPs. Responsible for approval of database screens, Edit checks designed in database and DCF/Query tracker. Internal Quality Control for all Data Management Documents like Data Management Plan, Annotated CRF, Functional Design Specification Document, and Edit check Specification Document. Responsible for Issuing the Database Test Certificate. Responsible for Database Lock and Unlock procedures. Responsible for exporting the data to SAS team for analysis. Responsible for Review and approval of Master Data Management File (MDMF). Responsible for Data Management Presentation in Investigator meeting. Providing inputs for proposal development in co-ordination with the Function Head.