Mounica chowdary

Clinical Data Manager

ad030n@r.postjobfree.com

682-***-****

PROFESSIONAL EXPERIENCE

Experienced Clinical Data Manager adept at managing databases and ensuring proper collection of key information. Proficient in the use of industry standard computer programs and applications.

Around 5 years of progressive hands-on experience in Clinical Data Management with one or more of the leading EDC software applications like Medidata Rave, Oracle Clinical and Inform.

Extensive experience in managing the data for the entire life cycle of multiple clinical trials (Phase I - Phase III), from protocol concept review through completion of the clinical study report.

Extensive experience in different phases of the clinical data management including study start up, study conduct and study lock.

Coordinated study start-up activities like CRF designing and annotation as per study specifics and protocol specific guidelines, Data Validation (edit check) Specifications, Data Management plan (DMP), data review guidelines (DRG), coordinated database live activities, tested/accepted clinical database for EDC studies.

Experience in Study Start up and database development activities like CRF designing, annotations as per study specifics and protocol specific guidelines, Data Validation/Edit Check Specifications, Data Management plan (DMP), data review guidelines (DRG) and UAT testing. Proficient in CDISC and CDASH guidelines

Efficiently handling multiple studies along with people management activities.

Outstanding ability to maintain and manage data.

Strong affinity to reduce extra efforts and work efficiently.

Knowledge in 21 CFR PART 11, ICH, GCP and GCDMP.

Knowledge in Medical Coding with MedDRA and WHO Drug

Extensive experience in handling start-up, study conduct and close out.

Communicated and coordinated with different global teams in various studies.

Worked extensively during study start up on CRF designing providing study specific and protocol specific guidelines.

Analyzes and resolves discrepancies in data validation or other reports.

Have extensive experience on various therapeutic areas like Viral diseases, Vaccine studies, Oncology, Hematology and Rare Diseases.

Expertise in working with vendor management, team management, client interaction and communicating with various other departments within the Clinical Research Domain.

Helped with troubleshooting and correcting database issues.

Good Knowledge in generating reports, tables, listings and graphs using SAS.

Developed and maintained Data Management Plans (DMP) and made sure they are followed throughout the project life cycle.

Worked extensively during study conduct on validating the data, cleaning the data, Discrepancy management, SAE Reconciliation and LAB Reconciliation along with development of IVRS.

Working experience in developing Data Transfer Agreements (DTA) with external vendors.

Expertise in Interim Analysis Reports, CRF tracking, database QC and Database Audit.

Worked extensively on study closing activities including Data Review, Data freezing and Study Lock.

Knowledge in Medical Coding with MedDRA and WHO Drug.

TECHNICAL SKILLS

Excel

MS Word

MS power point

J- Review

Medidata Rave

Oracle Clinical

Inform

GCP

CDISC

SQL

CERTIFICATIONS

The Structured Query Language (SQL)

ICH Good Clinical Practice

WORK EXPERIENCE

Client: International Vaccine Institute Feb 2016 to March 2021

Role: Clinical Data Manager

Responsibilities:

Responsible for completion of all activities leading to the study database lock.

Ensuring all study documents like DMP, CCG, eCRFs screen design are prepared and maintained for assigned studies.

Provide support in data review and quality control procedures in the operation of study data in EDC databases.

Responsible for tracking the coding of assigned studies.

Developed and test edit specifications along with creation of test scripts used for and UAT testing.

Created Data Validation Specifications (DVS) for robust edit check programming and testing of the clinical database.

Worked on Lab reconciliations including Local labs and central labs.

Vendor Management: Creating Data transfer agreements, working with the vendors on regular imports and reconciling the data.

Performed ECG Reconciliation and SAE Reconciliations

Reviewed and resolved discrepancies identified by the system or through manual checks as per guidelines.

Ensured data accuracy at different time points, validated clean reporting.

Performing the database testing and database audit as part of Quality Control

Freeze and lock data as appropriate in time for statistical review, interim and final database lock.

Coordinated with Clinical Data Management Staff, and Study Team to identify issues/trends for discussion.

Created Data Transfer Agreement (DTA) between external data vendors.

Experienced in performing SAE Reconciliation plan and completing SAE reconciliation.

Coordinated with database programming, medical coding, and statistical programming teams to ensure study progression.

Good knowledge on clinical data system design / development / validation.

Contributed towards developing guidelines/checklist that aids in streamlining of activities for Data Management (DM) during study close-out.

Monitors the quality and coordinates all data management QC activities for projects.

EDUCATIONAL QUALIFICATIONS

Master’s in health informatics

University of North Texas.

Bachelor of Dental Surgery

Drs. S&NR SIDS, India

Contact this candidate