ANNAPURNA KADMWAR

Email: ad0jlo@r.postjobfree.com Phone: 224-***-****

PROFESSIONAL SUMMARY

Over 5+ years of experience working in the field of Clinical Data Management delivering Data Review and Management objectives of various clinical studies in a timely manner.

Strong and comprehensive Clinical Data Management skills spanning from study Start-up, Study conducts and Close out activities

Extensive experience in working with eCRF design, Edit checks creation, User Acceptance testing (UAT), Lab data Reconciliation, SAE Reconciliation, Data cleaning and Query process.

Experienced in creating, updating and review of Data Management Plan (DMP), eCRF Completion guidelines (CCG), External Vendor Data Transfer Arrangements (DTA) and Data Review Plan (DRP) Documents.

Proficient in validating data in different phases of study by creating edit checks, query logics for efficient discrepancy management of data in EDC studies, and performance of UAT.

Experience working in study closing activities including Data Review through the pre-QC checklist, Data freezing and Study Lock.

Good Knowledge and understanding on ICH-GCP, GCDMP, 21 CFR Part 11, and FDA guidelines and regulations and CDISC and CDASH standards and Quality Management

Develop and/or revise Data Management SOPs, Work Instructions and templates/standards incorporating the industry’s best practices and any applicable Regulatory guidelines and requirements. Maintained efficient customer relationships within time frame and budget.

Ensured that the CROs and Third-Party Vendors are in alignment and are delivering per the scope of work.

Developed and maintained a close liaison with project client contacts, core team members, and Project Managers to drive the data management aspects of project delivery.

Performed Central Lab and Local Lab reconciliation in a timely manner and according to Working Practices

Identified areas for improvement of processes and implemented solutions for projects allocated.

Mentored new joiners and provided training on organization-specific Data management workflow.

An enthusiastic and project-oriented team player with solid communication and interpersonal skills with ability to develop creative solutions.

SKILLS

EDC systems: Rave, Inform

Data Management, CRF Design, Edit Check Specifications, UAT, Vendor Reconciliation, SAE Reconciliation, Data Validation.

Therapeutic Area: Oncology, Vaccines, Cardiovascular studies, Respiratory and Hematology, Alzheimer’s disease, Myotonic dystrophy, Hematologic malignancies, COVID vaccine, chronic kidney diseases and obesity studies.

Microsoft Office: MS Excel, Word, MS PowerPoint, Outlook.

WORK EXPERIENCE

CLINICAL DATA ASSOCIATE II: Mar2021 – present

Thermo Fisher Scientific (PPD)

Performed data management activities with focus on quality and study timelines as per study protocol.

Expertise in activities including from clinical trial Startup stage such as reviewing Protocol, developing/reviewing data management plan, developing/reviewing/annotating Case Report Forms, study conduct and trial lock stages.

Developed database specifications including eCRF specifications (SDR) & Edit check specifications (DVS/ECS), and annotation of CRF’s for assigned clinical trials.

Worked with cross Functional Teams to gather information and effective management the data life cycle of the studies assigned from start up to close out.

Proficiency in developing and maintaining Data Management plan (DMP), Data transfer agreements (DTA), CRF Completion guidelines (CCG/CCI) and other DM specific documents.

Successfully executed multiple projects simultaneously with different global teams and stakeholders while receiving little to no supervision.

Performed Quality check for the data by database testing and database audit.

Worked closely in association with data base programmer team, coding team, and statistical programmer to ensure quality and proper functioning of the data.

Freezing and locking of data for review, quality checks and then final lock of database.

Involved in performing SAE reconciliation by Comparing key safety Variables of reported AE’s and SAE’s for data consistency and accuracy between Clinical and Safety Database

Worked on Lab reconciliations including Local labs and central labs for effective data validation providing consistent, accurate and complete data.

Developed Test Data (Dirty and Clean data) to perform UAT of edit checks and validation of manual listings.

Retrieved and viewed all CRF pages individually that were already scanned and indexed in the automated workflow system.

Actively Oversaw the CRO’s and external data vendors to make sure that they need any extra input or knowledge sharing so that timelines are met properly.

Ensured FDA regulatory standards compliance (particularly 21 CFR part 11), performing quality assurance on electronic data capture tools.

Ensure adherence to the basic protocol requirements, SOP's, ICH GCP and Standard Guidelines.

CLINICAL DATA MANAGER

Sep 2018 –March2022

COGNIZENT

Reviewed CRF data for completeness, accuracy and consistency in accordance with all applicable procedures.

Validated data in accordance with the Data Validation plan (DVP/DRP) and Data Management Plan (DMP).

Worked extensively on Data validation, Discrepancy management (both auto and Manual listings) and handled Manual discrepancies by creating Smart Listings and Manual Listings every month.

Communicated with the site and CRA to resolve queries.

Worked as study data manager in the study team for all assigned internal and outsourced studies.

Involved in clinical data management activities in Phases I, II and III

Assisted in designing case report forms (CRF) and creating edit check specifications

Worked with SAS Programmer and database designing team to test functionality, comprehensiveness of Edit checks and listings.

Discussed and coordinated with the team and lead manager about the project and maintaining high quality deliverables within time.

Reviewed clinical data as per SOP, Protocol, and study-specific guidelines.

EDUCATION:

Master of Science in Microbiology - Osmania University, India

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