Pooja P Email and Phone Number

• Collaboration with various teams involved in the clinical trial process, including Clinical Operations, Safety, and Coders, is essential. This ensures that data management aligns with the overall study objectives.• Creating schedules and defining specific milestones for the project to ensure data quality and completion within set timeframes.• Working with stakeholders to design the CRFs, which are the structured forms used to collect data during the clinical trial.• Ensuring that Source Data Review (SDR) processes are effective in the development of electronic data capture (EDC) systems.• Creating detailed specifications for the database, including CRF specifications and edit check specifications, to ensure that data is captured accurately.• Creating documents such as the Data Management Plan (DMP), Data Transfer Agreements (DTA), and CRF Completion Guidelines to outline data management procedures.• Overseeing and managing all aspects of the clinical monitoring process, which involves site visits and data verification.• Conducting User Acceptance Testing (UAT) and Quality Control (QC) checks to ensure data accuracy and consistency.• Implementing data locking procedures at the end of the study after thorough data quality control.• Periodically reviewing trial data manually to identify discrepancies and manage queries in the Clinical Data Management System (CDMS).• Ensuring that data from external sources, such as serious adverse events (SAE) and lab data, aligns with the trial data.• Managing relationships and interactions with external partners involved in data collection or processing.• Adhering to international regulations such as ICH-GCP (International Council for Harmonization - Good Clinical Practice) and following institutional policies and Standard Operating Procedures (SOPs). Complying with data standards like CDISC and CDADH is also crucial.• Finalizing the data for statistical review, interim quality review, and database hard locking.

• Overseeing data management activities for assigned clinical trials.• Gathering requirements from the clinical team for the development of electronic datacapturing (EDC) system.• Collaborating with different stake holders of the study to develop case report forms (CRFs) and database for collecting clinical trial data.• Manage the data life cycle of the studies assigned from start up to close out.• Performed and coordinated all aspects of Clinical monitoring process.• Performed activities like Protocol Review, Reviewing of CRF, Annotation for CRF• Developing database specifications including CRF specifications & edit check specifications (DVS) for assigned clinical trials.• Authoring test scripts and performing user acceptance testing (UAT) of the database to make it available for the clinical trials.• Designing, generating, and reviewing of study metric reports as required by the study team.• Periodic manual reviewing of clinical trial data for discrepancies and query management.• Performing external data reconciliation such as serious adverse events (SAE) and labdata reconciliation.• Tracking and managing the status of allotted clinical trials in data management aspect• Developing data management plans (DMP), CRF completion guidelines (CCGs) and other study related documents.• Maintaining regulatory (ICH-GCP) and organizational procedures compliance in various data management processes.

• Developed and reviewed data management plans and data validation plans• Assisted in developing SOPs for various data management activities.• Demonstrating data review process with the sponsors and auditors when required.• Provided training to the newly employed clinical data analysts and guided othercolleagues of the project.• Involved in clinical data management activities in Phases I, II and III• Assisted in designing case report forms (CRF) and creating edit check specifications.• Created annotated CRFs based on the study protocol and CDASH requirements.• Developing the database and programming the specifications into the database• Developing and maintaining of study documents including CRF completion guidelines,DMP, Data validation documents, Data transfer agreements• Overseen manual and automatic discrepancy management activities.• Performed freezing and locking of the data for statistical review and final database lock.• Made sure the data management process is meeting the ICH-GCP guidelines.• Made sure the data management plan is following the regulatory guidelines.• Worked and provided assistance to other departments of the project as and when required.

• Develop CRF Completion Guidelines and obtain appropriate approvals.• Keep management abreast of issues and progress on all assigned projects.• Keep Clinical Data Manager (CDM) informed of any data issues or cleaning status on allassigned projects.• Collaborate with CDM on creating a manual review listing for assigned projects.• Mentor and train new and/or junior data management staff as requested.• Independently create and monitor regular performance reports that update theorganization on clinical aspects of the strategic plan, key performance indicators, and national initiatives• Receive and analyze supplemental databases that are evaluated for data quality and format.