Dr. Sruthi Lekha .
Clinical Data Management Coordinator @ WellFort Community Health Services
About
*Clinical Data Manager with years of experience in Clinical Data Management leading all data management expertise from Phases I to III and various therapeutic areas of clinical trials including Neurology, Immunology and many different drug discovery projects. *Proficient in working with Phase I to Phase III clinical trials using the EDC system. *I have a Sound knowledge of research study start-up, quality assurance, data review, data analysis, database clean-up, Lab Reconciliation, SAE Reconciliation and database finalization using clinical data management systems. *Extensive knowledge of CRF design, Edit checks Engine, data cleaning and Manual query process, Lab Data Reconciliation and SAE Reconciliation. Developed Data Management Plans and made sure to maintain DMP throughout the life cycle of the study project. *Develop Case Report Forms (CRF), Develop Database (DB) clinical trial data specifications including eCRF design, annotating CRFs, database design, Edit check specification, and Query logics. User requirements and data validation. *Well-versed in Database QC, CRF tracking, Database Auditing, Data lock and Freeze. *Experience in managing databases, including but not limited to performing MedDRA and /or WHO coding. Extensive experience with vendor management to ensure data quality and timely delivery. *Good Knowledge of the CDISC, CDASH, and CFR 21 Part 11 guidelines. *Extensive experience in developing, reviewing, and maintaining Data Management Plans (DMP), Data Transfer Agreements (DTA), and CRF Completion guidelines (CCGs). *Analyzes and resolves discrepancies in data validation or other reports. *Proficient in performing User Acceptance Testing (UAT) including validating data entry screens. *Proficient with using Electronic Data capture systems like Medidata RAVE, Medidata Classic, Jarvis, Tenhilo and Edid check engine. *Strong knowledge and commitment to adherence to ICH-GCP, GCP, CDASH/CDISC, FDA and IRB.
Canada
Brampton
Research
ICH, Clinical Trials, Validation Protocol, Data Validation, Data Reconciliation, Documentation Practices, Database Management System (DBMS), Document Management, Database Administration, PostgreSQL, Tibco spotfire, Discrepancy Resolution, Microsoft PowerPoint, medscape, ADR Recording, Medication Errors, Medication Adherence, Drug Interactions, Edit check Engine, eCRF
Experience

Clinical Data Management Coordinator
Toronto, Ontario, Canada
Oversee accurate and confidential data management using Accuro EMR to support community-based healthcare services. Generate reports and assist with data tracking to support clinical workflows, program evaluation, and quality improvement. Provide ongoing EMR support and basic training for staff to ensure efficient use of digital health systems. Collaborate with care teams and administrative staff to streamline processes and ensure compliance with healthcare privacy standards. Support initiatives that enhance patient care through organized data handling and system optimization.

Clinical data management
Bangalore Urban, Karnataka, India
I started working in the Clinical Research/ Life science (Clinical data management) Domain in the Abbvie Project, In Cognizant Technology where I managed most of the clinical & administrative tasks relating to the organization. Over the years, I've developed a variety of skills, such as the ability to maintain good relationships, good interpersonal skills, medical writing, data management, and so on. As a fresher, It was a Learning phase of my life, where in i was able to : •Ensure completeness and validity of the data in the clinical database. •Review and edit laboratory data,Clinical trial datas which has been loaded peridically as well as the reference information that support eCRF/ LAB data. • Review and edit traditional eECG, SAE data data which is loaded. •Cleaning the discrepancy data by providing manual queries to the Clinical site. •Writing Manual Queries, Uploading enrollment pages into the vendor’s website, assigning lab site ID’s to the lab, updating test codes in database etc.

CLINICAL PHARMACIST INTERN
Bengaluru, Karnataka, India
Monitoring Prescriptions for Drug Interactions, Medication Errors, and Adverse Drug Reactions. Minimizing the risk of treatment-induced adverse events, familiar with patient counselling. Monitoring the therapy course and patient’s compliance with therapy. Providing drug information and Dosage adjustments. Analyze patient case sheets and make a case report. Helped in improving medication adherence in chronic disease patients during research work.
Education

Medical/Clinical Assistant
To join a professional pharma field where I can utilize my knowledge and experience for the benefit of the society through team work. I aspire using my abilities and enthusiasm to learn more and build a solid career.
Dr. Sruthi Lekha .'s Contact Information
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