• Serving as the Sponsor Point of Contact (SPOC) for all Data Management activities, providing essential support on deliverables such as Go-live, Interim Analysis, and Database Lock (DBL) for assigned studies.• Conducting Sponsor quality checks, ensuring meticulous oversight of assigned studies to guarantee the Database was set up following the protocol and regulatory specifications.• Playing a pivotal role in the Data Review process, performing Sponsor quality checks, and providing thorough oversight of studies. This involved identifying and raising discrepancies to sites with precise query text, ensuring timely closure based on the right response and updates from the sites.• Actively participated in User Acceptance Testing (UAT) of the database during the setup phase, contributing to the development of Case Report Forms (CRFs) and engaging in Operational Study Report Meetings (OSRM), providing valuable inputs where needed.• Took charge of organizing and participating in essential meetings, including Data Review Team (DRT) meetings and Study Status meetings, ensuring that the Contract Research Organization (CRO) delivered services with the utmost quality and within agreed timelines.• Exercising keen scrutiny, reviewing, and approving all key study documents, including MOCK CRF, Edit Check Specifications (ECS), Study Specification (SPS), Data Transfer Specifications (DTS), electronic CRF Completion Guidelines (eCCG), Data Handling Plan (DHP), etc.• Conducting Quality Control (QC) of the data, identifying errors and inconsistencies, ensuring that these were promptly raised to the CRO Data Management team for resolution.

Study Setup Activities:Development of Mock CRF and Study Documents:• Played a key role in developing Mock Case Report Forms (CRFs) and essential study documents, including Data Handling Plan (DHP), Edit Check Specifications (ECS), CRF Completion Guidelines (CCGs), Data Transfer Specifications (DTS), etc. These documents served as foundational elements in the study setup process.Collaboration with DBP Team for Clinical Database Development:• Collaborated closely with the Database Programming (DBP) team to ensure the development of the Clinical Database aligned with the Study Specification (SPS) and other study documents. Actively participated in User Acceptance Testing (UAT), conducting both Screen UAT and Edit Check UAT using dummy data entry to validate the functionality and accuracy of the database.Creation of Data Transfer Agreements (DTAs):• Took charge of creating Data Transfer Agreements for all Third-Party data.Contribution to Study Go-Live Activities:• Contributed significantly to all activities leading to Study Go-Live. This involved coordinating various aspects of the study setup, ensuring that all necessary components were in place for the study to progress to the next phase.Study Conduct and Closeout Activities:DRT - Data Review Meetings:• Organized Data Review Meetings (DRT) involving all stakeholders to facilitate comprehensive data review discussions. This ensured that a holistic approach was taken towards data quality and consistency.Review of Protocol Deviations and SAE Reconciliation:• Thoroughly reviewed all protocol deviations and engaged in Serious Adverse Event (SAE) reconciliation activities to address any issues promptly and ensure compliance with protocol requirements.Vendor Data Reconciliation:• Executed reconciliation activities for various vendor data sources, including ePRO, IVRS, Lab, PK, and Imaging data, to harmonize data from different origins.

Query Management:• Actively engaged in the query management process by meticulously reviewing data through data listings. Identified and raised queries on discrepant data to ensure data accuracy and consistency.SAE Reconciliation and LAB/Vendor Data Reconciliation:• Conducted thorough reconciliations, including Serious Adverse Event (SAE) reconciliation and reconciliation of Laboratory (LAB) and Vendor data. Ensured alignment of data across various sources for comprehensive data integrity.User Acceptance Testing (UAT):• Participated in User Acceptance Testing (UAT) activities, covering both Screen and Edit checks. Ensured that the database met specified requirements and functionalities.Contribution to Study Documents:• Played a key role in the development of essential study documents, including the Data Handling Plan (DHP), Edit Check Specifications (ECS), and CRF Completion Guidelines (CCGs). These documents were vital for maintaining standardized processes and data quality.Metric Reports:• Generated and analyzed metric reports such as Open Query and Closed Query reports. These reports provided insights into the status of queries, facilitating effective communication and resolution strategies.• By actively participating in these tasks, I contributed to the overall efficiency and quality of clinical data management processes.

• Managed entry and review of patient performance and progress data as a Lead Physical Therapist. • Supervised and trained junior therapist and PT assistance in day-to-day operations.• Highlighted and communicated key performance indicators (KPI) to summarize patient progress.• Performed review and verification of reports compiled by co-workers to ensure accuracy and compliance.• Discussed patient cases with doctors, social workers, nurses, psychologists, and other medical professionals. Often negotiated with insurance providers to get approval on treatment programs.• Educated patients and families on patient safety and home exercise programs.• Treated patients with varying diagnosis which included manual techniques, therapeutic exercise, and patient education.

• Provided physical therapy intervention using therapeutic exercise and activities to restore functional capacity and achieve maximum performance.• Worked closely with Occupational Therapists and nurses to discuss and align appropriate treatment plans for patients.• Managed a diverse range of residents, including geriatric, psychiatric, Alzheimer’s, short-term disability cases such as post Motor Vehicle Accidents (MVA), fractured lower extremities post falls, kidney disease, cancer, and generalized weakness