Dr. Sruthi Lekha .

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.

Country

Canada

City

Brampton

Industry

Research

Skill

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

WellFort Community Health Services

Clinical Data Management Coordinator

WellFort Community Health Services

LinkedIn
2025-6 - Present · 1 yr 4 mos

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.

WellFort Community Health Services

Healthcare Assistant

WellFort Community Health Services

LinkedIn
2024-11 - 2025-5 · 7 mos

Toronto, Ontario, Canada

Canadore@Stanford College

Student

Canadore@Stanford College

LinkedIn
2023-5 - 2024

Greater Toronto Area, Canada

Cognizant

Clinical data management

Cognizant

LinkedIn
2022-2 - 2023-5 · 1 yr 4 mos

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.

Rajiv Gandhi University of Health Sciences

CLINICAL PHARMACIST INTERN

Rajiv Gandhi University of Health Sciences

LinkedIn
2019-6 - 2021-8 · 2 yrs 3 mos

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.

ALICON PHARMACEUTICAL PVT. LTD

Internship Trainee

ALICON PHARMACEUTICAL PVT. LTD

LinkedIn
2017-9 - 2018-11 · 1 yr 3 mos

Gujarat, India

Education

Rajiv Gandhi University of Health Sciences

Rajiv Gandhi University of Health Sciences

LinkedIn

Medical/Clinical Assistant

2018-8 - 2021-10 · 3 yrs 3 mos

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.

Canadore College

Canadore College

LinkedIn

Health/Health Care Administration/Management

2023-5 - 2024-1 · 9 mos
Savitribai Phule Pune University

Savitribai Phule Pune University

LinkedIn

Pharmaceutical Sciences

2014-8 - 2018-6 · 3 yrs 11 mos

Good knowledge on drugs and medicines, Pharmaceutical Engineering, Medicinal Chemistry, pharmacology, biochemistry. Good practical knowledge.

Canadore College

Canadore College

LinkedIn
2024-1 - 2024-12 · 1 yr

The project Management course equipped me with the knowledge and skills necessary to successfully lead and manage projects of varying scope and complexity, preparing me for a dynamic and rewarding career in project management.

Canadore College

Canadore College

LinkedIn

Dr. Sruthi Lekha .'s Contact Information

Email

******@***.com

Phone

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