Aparna Nair

• Maintained files, records, and chronologies of entry activities.
• Consistently met deadlines and delivered high-quality work, demonstrating a strong commitment to excellence in data management.
• Reviewed and updated client correspondence files and database information to maintain accurate records.
• Handled information requests for public and protected data, employing proper procedures to handle each and protect important assets.
• Managed sensitive information responsibly, adhering to strict security protocols and maintaining confidentiality at all times.
• Streamlined data management for improved decision-making, through effective organization and storage of complex datasets.

● Create and manage the timeliness of clinical data science tasks throughout the course of studies, focusing on data review and the achievement of data delivery milestones.
● Designed case report forms (CRFs) that accurately reflect study protocol requirements.
● Spearheaded the organization of data pertaining to adverse events in clinical studies and post-market drug scenarios
● Extensive knowledge of ICH-GCP, CDASH and HIPAA guidelines and hands-on experience of EDC systems.
● Participating in and leading the development and maintenance of the data management plan
(DMP), Data Transfer Specifications Data Validation Specifications and eCRF Completion Guidelines.
● Performed SAS validation, eCRF validation, functionality testing for the fusion eClinical suite.
● Assisted Data Management department in developing eCRF, Data Validation specifications and study specific procedures and conducted thorough reviews of regulatory reporting requirements.
● Assisting the Lead Data Manager in performing data management activities. These activities include and are not limited to, writing Data Management Plans (including specifying database integrity checks), designing clinical trial Case Report Forms, designing databases, monitoring data flow and quality control processes.
● Collaborating with multi-functional project teams to identify, modify, maintain, test and review project data, and related templates (eCRF/CRF) documents and reports.
● Providing high level support in SAS testing of extracts including test data entry for various sites
in all stages of environment (QA, Stage and Production)
● Participating in the financial allocation, time commitment, and resource planning for the activities involved in reviewing clinical data.
● Coordinating in study start up activities like CRF designing and annotation as per study specifics and protocol specific guidelines, Data validation (edit checks) specifications, data review guidelines and participate in audits

● Assist in Validation of Day-to-Day client deliverables, as well as supporting Functionality testing for the fusion eClinical suite platform

● Perform SAS Validation, eCRF validation, functionality testing, Data update testing, Data extract validation.

● eCRF and DES implementation and collaborated with various departments for SAS Organizing tasks

● Perform various fusion related tasks and Assisted the Lead Data Manager with the preparation of study documentation following CDISC standards.

● Actively engaged in clinical risk management activities.

● Conducted thorough analytic reviews as per the defined scope of work and functional plans, prioritizing errors with significant implications for subject safety or the interpretation of final analysis.

● Played a key role in Sponsor audits, ensuring compliance with established standards and protocols.

• Engaged in daily communication with PayPal customers to address inquiries, resolve issues, and provide assistance with account-related matters, ensuring a high level of customer satisfaction.
• Acquired comprehensive knowledge of PayPal's products and services to effectively guide customers through various transactions and troubleshoot issues, ensuring efficient problem resolution.
• Collaborated with team members and cross-functional departments to share knowledge, address escalated issues, and contribute to a positive and productive team environment, fostering continuous improvement.

● Coordinated and managed clinical research data processes as a Clinical Data Coordinator
● Designed and implemented Electronic Case Report Forms (eCRF) for accurate and comprehensive data collection.
● Successfully negotiated timelines and key deliverables with clients, external customers, vendors,
and departments to meet project requirements.
● Proficient in Electronic Data Capture (EDC) systems, ensuring streamlined data entry and
validation.
● Maintained data integrity throughout the clinical data lifecycle.
● Spearheaded the management of timelines for clinical data initiatives throughout study life cycles, ensuring alignment with data review and delivery milestones.
● Took responsibility for crafting planning documents related to data review, data analytics, and overall data deliverables.
● Collaborated with cross-functional teams to support the seamless execution of clinical research
studies

• Assisted customers with inquiries, provided information on medications, and offered guidance on over-the-counter products.
• Processed prescriptions efficiently, ensuring accuracy and compliance with regulatory requirements.
• Prepared and dispensed medications under the supervision of a licensed pharmacist, ensuring precise dosage and labeling.
• Assisted with pharmacy administrative tasks, including answering phone calls, scheduling appointments, and managing patient records.
• Communicated effectively with patients regarding medication instructions, side effects, and storage requirements.