Tejaswini Madeneni

Mobile: 647-***-**** email: adw9qs@r.postjobfree.com

Toronto, ON, Canada

Career Objective

To work in a challenging environment where there is constant scope for learning and utilizing the skills developed through experience and being resourceful to the organization in providing quality data by following GCDMP.

Professional Summary

• Astute and versatile professional offering over 6 years of experience in Clinical Data Management. Successfully led and managed Data Management activities for various projects in different phases (Phase I, II and III) of clinical trials.

• Expertise in working with study start-up, conduct and close-out activities.

• Outstanding ability to plan, analyse and accomplish the CDM objectives in a timely manner.

• Have hands-on experience in creating and updating data management plan (DMP), data transfer agreements (DTA), and data review plan (DRP) and delivered all operations according to client quality and integrity specifications.

• Prepared CRF completion guidelines (CCG) and provided EDC training to new core members of the data management team.

• Excellent communication and problem-solving skills with a deep interest in science. Professional Experience

Lead Clinical Data Manager – IQVIA, Canada May 2020 – Present

• Developed, reviewed, and maintained trial-specific data management documents including data management plans (DMP), data review plan, CRF completion guidelines, data validation plan

(DVP) and external data transfer agreements (DTA) throughout the lifecycle of the project and ensured adherence to the project requirements.

• Represented Data Management in internal study team, client and CRO meetings.

• Performed comprehensive review of all data generated from the clinical study including Third Party/External data, SAE data and local lab data.

• Led the development of data edit check specifications and data listings.

• Managed and monitored project timelines and assured resources are available to meet project milestones and ensured high quality on every deliverable.

• Involved in planning and overseeing the development of specifications for eCRFs/CRF, edit checks, electronic data handling, manual review and execution of User Acceptance Testing(UAT).

• Coordinated in completion of various duties, including data transfers and quality reviews of the database, database lock, archival of data management. Clinical Data Manager – IQVIA, Canada Jan 2019 -April 2020

• Key role in providing and assisting in the development and maintenance of SOPs and any other documentation related to data management activities.

• Ensured and established study protocols were implemented and followed according to ICH GCP.

• Ensured all data domains in CRFs are created based on CDISC-CDASH standards during CRF design and clinical database build-up.

• Developed standard process for data collection, data entry, integration, monitoring, review edit checks specifications, and report to align with regulatory compliance.

• Participated in Study meetings.

• Worked on study conduct activities like Data Validation, Discrepancy management, Coding, SAE reconciliation and Lab reconciliation.

Clinical Data Associate – Novartis, Hyderabad, India Jan 2016 -Sep 2017

• Involved in creating Edit check specification and performing UAT.

• Worked on serious adverse events (SAE) and lab reconciliations.

• Responsible for discrepancy management and reviewed Query track report, SAE track report and raised questions for inaccurate, inconsistent, missing data.

• Implemented and maintained standard operating procedures and audit policies. Education

o Healthcare Administration and Service Management- Conestoga College, Canada o Doctor of Pharmacy(Pharm-D)- Acharya Nagarjuna University, India Skills

Database/EDC Systems Medidata Rave, InForm

Therapeutic Areas Cardiology, Obesity, Diabetes, Respiratory, Gastroenterology

Operating Systems MS Office Word, Excel, Access, MAC Activities Query Management, Database testing UAT, Quality Control and

locking databases.

Guidelines CDISC/CDASH, SDTM, MedDRA, WHO Drug,

GCP/ICH

and 21 CFR part 11.

Programming Base SAS

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