Laya Bindu Simhadri

Located in San Jose, CA

Summary:

Clinical Data professional with experience working in pharmaceutical industry.

Hands on experience in clinical data management, data validation, Vendor and SAE reconciliation and EDC systems like Medidata RAVE and clinbase.

Responsible for performing CRF review for completeness, accuracy, and consistency.

Hands on experience working on studies in different Clinical Research Therapeutic Areas including Oncology, Ophthalmology, Respiratory etc.

Hands-on experience in clinical data management end to end process study start up, conduct and close out.

Experienced working on Data Review and SAS listing review manually.

Responsible for reviewing and resolving queries on an ongoing basis and updating the database appropriately by Data Management Plans (DMP) and applicable standardized data management tasks, as assigned.

Experienced working on Data Management related operational data flows as assigned.

Responsible for ensuring that all Data Management activities are conducted in compliance with Good Clinical Practice guidelines.

Good understanding of International Conference of Harmonization/Good Clinical Practice (ICH GCP) Guideline and good understanding on FDA.

Education:

Rajiv Gandhi University of health sciences, India

Doctor of Pharmacy – Pharm D

Project- Clinical research project “Assessment of Risk factors and Pharmacotherapy patterns in chronic kidney disease patients”.

Skills:

Medidata RAVE and Clinbase database.

Data Validation and cleaning in RAVE database.

Query management using Medidata RAVE database.

Reconciliation- Vendor, SAE and Lab.

Perform early and final database activities.

Conduct SAE and third-party data reconciliations

Database lock activities.

Maintaining clinical study documents and archiving as appropriate.

Test data creation and UAT.

Trained for HIPAA for virtual assistant.

EMR and prognosis database.

ICD 10 medical coding experience.

Good understanding on ICH-GCP.

Knowledge on medical terminology using MedDRA and WHODrug dictionaries.

Microsoft office software such as word, excel and power point.

Effective team management to meet daily metrics and objectives.

Good Communication and problem-solving skills.

Ability to work in team environment and independently.

Good Analytical skills and attention to detail.

Professional Experience:

Parexel International India Safety Services Feb 2022 – Mar 2023

Clinical Data Analyst I

Independently and proactively performed all clinical data cleaning activities as a part of validation on assigned projects.

Experience of working in Clinical Data Management systems RAVE, Clinbase and have the knowledge on Oracle Clinical database and RAVEX.

Performed CRF review for completeness, accuracy, and consistency.

Have a thorough knowledge of data validation processes (Identify discrepancies in Clinical Data – edit and manual checks/Listings, Discrepancy review, Query management – Review & Resolution) along with Due diligence process.

Worked on studies in different Clinical Research Therapeutic Areas including Oncology, Ophthalmology, Respiratory etc.

Good understanding of International Conference of Harmonization/Good Clinical Practice (ICH GCP) Guideline and good understanding on FDA.

Good Knowledge of 21 CFR Part 11.

Hands-on experience in clinical data management end to end process study start up, conduct and close out.

Performed Reconciliation on vendor, SAE etc.

Taken accountability of the work assigned and completes on time.

Updated the vendors and other trackers proactively.

Worked on Data Review and SAS listing review manually.

Generated Metrics as per project requirements.

Coordinated with team for data cleaning and query resolution activities.

Learnt to work on study set up activities test case writing and DMP update.

Parexel International India Safety Services Mar 2021 – Feb 2022

Associate Clinical Data Analyst

Followed applicable departmental Standard Operating Procedures and Work Instructions.

Completed required training according to timelines.

Reviewed and action queries on an ongoing basis and updates the database appropriately by Data Management Plans (DMP) and applicable standardized data management tasks, as assigned.

Performed UAT according to Validation Plan for applicable Data Management systems (if applicable).

Generated, resolved, and tracked queries to address inconsistent data identified during data review activities and apply proper modification/correction to the database.

Worked on Data Management related operational data flows as assigned.

Ensured that all Data Management activities are conducted in compliance with Good Clinical Practice guidelines.

Performed other duties as assigned by the study and/or Line manager.

Other activities like data entry of patient case report forms in Oracle Clinical database.

Virtual Physician Scribes Private Limited Aug 2019 – Dec 2020

Virtual Physician Assistant

Assisted the physician in completing the patient’s case report via telephone using internet and completing the Electronic Health Record of the patient under the physician’s guidance.

Identified the diagnosis and entered the diagnosis in the EHR using ICD 10 coding of the diseases.

Experience with EMR and Prognosis database.

Trained in HIPAA.

Reviewed patients case report form for any interactions and discuss with the health care provider.

Kempe Gowda Institute of Medical Sciences Aug 2018 – Aug 2019

Clinical Pharmacist Intern

Assisted health care providers with patients’ case report form completion.

Reviewed for any drug - drug and drug-food interactions.

Patient counseling.

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