Key Responsibilities: Act as a representative of Clinical Data Management and attend project kick off meeting Mentoring new joiner and team members on CDM process and SOPs as per assignment Follow and provide the guidance to the team on Data Management Plan requirements Project management includes tracking and sending of Study Progress Report to sponsor and other stakeholders To mentor and coordinate with BABE eCRF designer of CDM and other departments… Show more Key Responsibilities: Act as a representative of Clinical Data Management and attend project kick off meeting Mentoring new joiner and team members on CDM process and SOPs as per assignment Follow and provide the guidance to the team on Data Management Plan requirements Project management includes tracking and sending of Study Progress Report to sponsor and other stakeholders To mentor and coordinate with BABE eCRF designer of CDM and other departments Preparation and review of Data management SOP’s and other process related documents Preparation of Data Management Plan (DMP) Preparation, review and / or approval of documents generated during life of the project. E.g. Case Report Form (CRF), CRF Completion guideline, Annotated CRF, Data Validation Plan (DVP), edit check document, project specific self evident correction, Consent for Database lock etc. eCRF / Database designing and testing  Dictionary management, medical coding and SAE reconciliation Edit checks implementation, testing and documentation Data validation includes DCF generation and resolution, manual review of clinical data to check the discrepancy(ies) Correction of clinical data as per investigator’s suggestion or Self Evident Correction Perform Database Lock Preparation and review of other document(s) related to CDM process and project(s)  Check study specific CDM binders for its completeness and correctness Archiving of study specific documents and document controls Coordination within and across the department for project related activity(ies) Coordination with sponsor for any project related activities along with clinical data manager/ HOD  Project status updates and timeline management for the assigned projects Follow the CDM SOPs, other departmental SOPs and applicable regulatory guidelines Show less

Follow the Data Management Plan requirement throughout the project including roles and responsibility. Preparation and review of documents generated during life of the project. E.g. Case Report Form (CRF), CRF Completion guideline, Annotated CRF, Data Validation Plan (DVP), edit check document, project specific self evident correction etc. Database testing. Edit checks implementation, testing and documentation. Discrepancy Management includes DCF… Show more Follow the Data Management Plan requirement throughout the project including roles and responsibility. Preparation and review of documents generated during life of the project. E.g. Case Report Form (CRF), CRF Completion guideline, Annotated CRF, Data Validation Plan (DVP), edit check document, project specific self evident correction etc. Database testing. Edit checks implementation, testing and documentation. Discrepancy Management includes DCF generation and resolution, manual review. Correction of clinical data as per investigator’s suggestion or Self Evident Correction. eCRF designing for in-house projects conducted by clinic department. Preparation and review of other document(s) related to CDM process and project(s). Coordination within and across the department for project related activity(ies) Coordination with Clinical Trial Team for query resolution and data cleaning. Mentoring new joiner on CDM process and SOPs as per assignment. Overall compliance with CDM SOPs, other departmental SOPs and applicable regulatory guidelines. Q.C. and documentation Work with Paper CRF and e CRF Updating the clinical database Maintenance of study specific binder Show less