● Client Facing and subject matter expert in data management.● Responsible for overseeing up-to-date and quality data entry into electronic data capture system (EDC) by clinical sites.● Perform data management study close-out activities including final reconciliation and quality control steps in accordance with Company SOPs.● Ensures approved study documentation is maintained and properly stored in the trial master files.● Ensures adherence to Good Clinical Practice and all applicable local and international regulations.● Worked as a Lead Data Manager on various clinical study projects.● Responsible for creating the Data Management Plan according to Sponsor SOP & Guideline.● Responsible for tracking completion of source worksheets.● Develops & Designs Case Report Forms & Review of sponsor generated CRFs.● Work with Project Manager and Monitors for query resolution; abstracts data from necessary sources to complete the EDC and resolve queries.● Responsible for maintaining key clinical study data for reporting to the Data Operations Manager and the clinical team.● Provide status updates on data entry and data quality metrics.● Performs Data Validation & Edit Checks ● Performs Vendor Reconciliation of Central Lab Data, ECGs, X-Rays & SAEs.● Maintain working knowledge of protocol (and associated amendments) for effective collection of data and effective communication with clinical sites as needed.● Supports the preparation of data reports.● Performs Data Cleaning and query handling.● Adhere to data security and confidentiality requirements when handling confidential data.● Provides support in maintaining and archiving clinical study documents.● Ensure accurate and clean data with MedDRA Coding Standards.

● Working knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, UAT, the drug development process● Assists the Clinical Data Manager(s) [CDM] in any assigned clinical data management tasks across multiple projects.● Support CDM process and application improvements; participate in working groups to develop and implement new processes and applications.● Develop test plans and perform testing to validate databases built by other members of the data management team.● Perform other duties as assigned by management.● Create User Acceptance Test Scripts from Edit Check Specifications and create dummy data to test edit checks and to test database screen functionality.● Assisting in establishing and enforcing departmental standards● Review and clean data errors for consistency and accuracy according study guidelines and conventions.● Perform Site/User Administration to allow access to the database, ensuring all users are qualified to access data base.● Good knowledge of processes and procedures in clinical data management● May participate in development and review of SOPs, work instructions, and associated documents for CDM, including recommending revisions and updates to SOPs, participating in the development of user training.● Participate in project management activities for a cohort or project to bring clinical studies on-line, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders.● Good knowledge of protocols, DMPs, and SAPs● Develops solutions to a variety of problems of basic scope and complexity.

● Creates visually impactful dashboards in Excel and Tableau for data reporting by using pivot tables and VLOOKUP.● Analyze the product line and the overall profitability of the business.● Increase efficiency by 95% by writing macros in excel to automate report generation.● Verifies that data repositories provide consistent, reusable data, and identifies and communicates data limitations.● Worked with data engineers to synchronize the use of data among several business locations by moving databases to the cloud.

● Presented daily analyst performance reports to the management team using powerPoint and Excel Pivot tables. ● Calculated and prepared financial report for underwriter’s commission.● Filter and clean data by reviewing computer reports, printouts and performance indicators to locate and correct code problems. ● Locate and define new process improvement opportunities.