Nileema D'Souza

• Lead end-to-end medical data review across ~20 global clinical trials, from study startup to database lock, across various therapeutic areas. • Collaborate closely with Medical Directors to develop and implement study-specific medical plans, including Medical Data Review Plans, Medical Monitoring Plans, and Eligibility Review Plans. • Collaborate in drafting and reviewing study protocols, eCRFs, Data Management Plans, Edit Checks, and Medical Monitoring documentation. • Conduct ongoing and ad-hoc medical data review of listings, patient profiles, and data visualizations to identify trends, and potential safety risks. • Perform data review (e.g., AEs, labs, ECGs, vitals, RECIST), generate and resolve medical queries, and approve query closure in collaboration with Medical Directors. • Serve as a liaison between Medical Monitors, Project Managers, Data Management, Clinical Operations, and Sponsor teams to ensure medical review goals are aligned and risks to data integrity or patient safety are addressed proactively. • Actively contribute to key study team meetings, including internal reviews, Safety Review Committees, Dose Escalation meetings, and DSMB sessions, supporting data-driven decision-making and medical reporting. • Implement Risk-Based Monitoring strategies by defining key data points and contributing to the Integrated Data Review Plan. • Drive improvement in review processes by serving as Subject Matter Expert (SME) for tools like JReview and Spotfire, leading UAT and internal training initiatives. • Ensure timely organization of study documents in the Trial Master File (TMF), supporting audit readiness • Attend meetings and participate in internal and external audits as required. • Mentored and trained new team members, supported team leads, and contributed to developing best practice guidelines. • Recognized multiple times as “Medical Data Reviewer of the Month” (Sep 2023, Feb 2024, Feb 2025)

• Completes all accountabilities previously listed including additional responsibility for oversight/ownership for these accountabilities. • Independently drafts the Medical Data Review Plan (MDRP) according to PRA standards, contract and client expectations (AWARD report / Proposal) • Independently coordinates project-specific tasks such as review of the electronic Case Report Form (eCRF) and CRF Completion Guidelines (CGS). • Raises and closes queries with minimal or w/o support of the Medical Director (MD). • Conducts medical review of the data as per MDRP on incremental listings and subject profiles in close collaboration with MD, using pre-established criteria to assure that the data is medically plausible and to clarify inconstancies and missing Adverse Events (AE). • Reviews data for protocol deviations

• Trained in Good Manufacturing Practices (GMP) and documentation of clinical processes • Reviewing and responding to quality control findings in the products

• Gathering and entering patient information and doctors' prescriptions in computer systems • Assessing prescriptions for completeness • Preparing and packaging prescription medications • Compounding non-sterile pharmaceutical products • Maintaining prescription and inventory recordkeeping systems • Maintain proper drug storage and security • Receiving orders for stock to maintain inventory.

• Served independently as a Clinical Data Coder (Coder) for one or more protocols with less than 5 operations staff, with guidance. • Performed Medical Coding using MedDRA, WHO Drug and/or other relevant dictionaries as applicable. • Validates/tests the coding set up and programming of coding reports; also test databases, edit specifications or any related programming activities. • Served in the role of back-up to a lead coder. • Conduct data review. • Write and resolve data clarifications. • Performed Serious Adverse Event (SAE) reconciliation activities. • Understand and comply with core operating procedures and work instructions. • Performed other duties as directed by the Lead Coder, Data Team Lead or Manager. • Meet objectives as assigned. • Developed and maintained good communications and working relationships with the Data management team.

• Coding of clinical data (MedDRA & WHODD) • Conduct basic data review. • Write data clarifications as directed by the Data Operations Coordinator. • Resolve data clarifications, as directed by the Data Operations Coordinator. • Conduct basic quality control procedures. • Meet personal project objectives, as assigned by manager. • Escalate problems to the attention of the Data Operations Coordinator or Group Manager. • Understand and comply with core operating procedures and working instructions. • Understand, provide input to and comply with all applicable sections of Data Management Plan. • Understand basic database structures. • Develop and maintain good communications and working relationships with CDM team.

• Drafted a comprehensive research protocol for a retrospective observational study on leptospirosis. • Defined inclusion and exclusion criteria, severity indicators, and outcomes using CDC and WHO guidelines. • Designed structured Case Report Form and Informed Consent to capture demographic, clinical, and laboratory data for 500+ patients. • Ensured alignment with regulatory criteria and study objectives for robust data collection. • Extracted patient records and compiled clinical data from hospital databases spanning a five-year period. • Prepared and submitted study documents to the Institutional Ethics Committee (IEC) for approval, ensuring adherence to ethical standards and regulatory guidelines for human subject research. • Performed descriptive and inferential statistical analysis using SPSS (v20.0). • Authored thesis abstracts and discussion based on analyzed data and literature review. • Interpreted statistical findings to formulate clinical insights and conclusions.

• Involved in learning the procedures followed in Production, Quality control, Quality assurance and Packaging department as per Good Manufacturing Practices. • Assisted in quality control testing and packaging. • Performed the testing methods, validation, document control and equipment calibration.

• Rendered community services to improve patient’s health outcomes by enhancing compliance to prescriptions. • Provided drug information services to healthcare professionals and patients. • Participated in health screening and community outreach program to raise awareness about drug use.

Pharmacotherapeutics Clinical Research and Drug Development Pharmacokinetics, Toxicology and Bio statistics Hospital and Community Pharmacy

Pharmacology Medicinal Chemistry Pharmacognosy Pharmaceutics Pharmaceutical Biotechnology Therapeutics Pharmaceutical Analysis Pharmaceutical Management