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Click here or scroll down to respond to this candidatePROFESSIONAL SUMMARYCandidate's Name 8 years of experience in the clinical data management by working on a variety of studies and phase (I-IV) of clinical trials.Outstanding ability to plan, analyze and accomplish the CDM objective in a timely manner.Proficient experience in Paper & EDC Clinical trialsStrong and comprehensive CDM skills spanning from study start up, study conduct, close out and medical coding activities.Proficient in eCRF design specification, Edit check creation, data cleaning and query process, SAE reconciliation and lab data reconciliation.Exceptional knowledge of ICH GCP, GCDMP, CDISC & US FDA safety reporting and guidelines.Expertise in CRF tracking, database QC and Database Audit.Experience in working with EDC databases like Oracle Clinical RDC, Inform and Medidata Rave.Experience in updating Standard Operating Procedure (SOPs)Expertise in collaborating with vendor management, team management and client interaction and communicating with various other departments within the Clinical Research Domain.Good interpersonal and communication skillsSkills summary: Data Analysis, DMP, ECRF design, UAT, QC, Discrepancy Management, Data Lock Activities, SAE reconciliation, External vendor data reconciliation, CDISC, GCP,21CFR part 11, Medidata Rave, Inform and Oracle Clinical RDC..WORK EXPERIENCE:Bristol Myers Squibb (BMS) Feb-2016 To Sep-2019Data Management Lead ( RAVE and ORACLE )Organization: Accenture SolutionsResponsibilitiesReviewed clinical research study protocols.Manages DM-related aspects of the project.Represents DM as the functional lead at internal and sponsor project team meetings.Provides initiative-taking, timely communication of project status, data trends and issue resolution with internal team and Sponsor.Develops, generates, and analyzes project progress and/or metric reports, reporting summary of findings and remediation activities, as required, to DM management, project team and Sponsor.Works with DM program and/or administrative manager to provide resource and budget projections.Discusses roadblocks and proposed solutions for completing project objectives in a timely manner.Participates in regulatory and Sponsor audits for assigned study.Oversees daily team member activities.Assures project activities are performed within budget and according to expected timelines and meet high quality standards.Reviews DM team member activities and deliverables to ensure plans and processes are followed.Developed and Maintained project documents like DMP, Data validation documents, CRF completion guidelines and Data transfer agreements.Created annotated CRFs based on the protocol specifics.Performed clinical trial data management activities for Phases I to IV.Involved in the training of internal team, CRAs, CRO and vendors based on the project requirements.Participated in study set-up, validation, and implementation of clinical databases.Involved in creating Edit check specification and performing UAT using Phase forward INFORM.Performed QC of data for several trials.Proficiency in running Python scripts for the purpose of extracting data and producing reports.Interacted with the sites and CRA to coordinate error resolution using data clarification forms (DCFs).Reviewed clinical data and resolved outstanding errors & discrepancies.Ensured the studies are conducted as per the SOPs, ICH GCP, protocol requirements and standard guidelines.Executed SAE reconciliation and external vendor data reconciliation for several clinical trials.Responsible for supporting database locking activities, like planning and executing listing reviews and identifying remaining clinical and monitoring tasks.Bristol Myers Squibb (BMS) Jun-2013 To Feb- 2016Data Management Analyst (Clinical Report Form processing)Organization: Accenture SolutionsResponsibilitiesDesigned CRFs.Communicate with all the stakeholders of project regarding data management issues.Ensure the eCRF meets the data collection requirements of the study through review of the protocol and other supporting documentation.Reviewed edit-checks included in the Data Validation Plan as agreed with the sponsor.Ensure external data are transferred and reconciled with the clinical database.Perform database lock activities in close collaboration with sponsor, Project Coordinator/Manager, statistician, and other parties.Responsible for supporting Database locking activities, like planning and executing listing reviews and identifying remaining clinical and monitoring tasks.Performed Quality Check of the data by manual review.Generated and reviewed EDC/UAT functionality, comprehensiveness and edit checks.Developed and executed queries in clinical databases.Performed Lab, SAE Reconciliation and external vendor data reconciliation for several clinical trials.Contributed towards developing guidelines/checklist that aids in streamlining of activities for Data Management (DM) during study close-out.Responsible for supporting Database locking activities, like planning and executing listing reviews and identifying remaining clinical and monitoring tasks.Played a key role in aiding the closing of database for deliverable to the FDA.Ensured FDA regulatory standards compliance (particularly 21 CFR part 11), performing quality assurance on various electronic data capture tools.Serco (Intelenet global services) Dec-2011 To Jun-2013Medical coding AssociateResponsibilitiesMaking sure that codes are assigned correctly and sequenced appropriately as per government and insurance regulationsComplying with medical coding guidelines and policiesReceiving and reviewing patients charts and documents for verification and accuracyFollowing up and clarifying any information that is not clear to other staff membersCollecting information made by the Physician from different sources to prepare monthly reports.Implementing strategic procedures and choosing strategies and evaluation methods that provide correct results.Examining any medical malpractice that has been reported by analyzing and identifying the medical procedures, diagnoses or events that lead to the negligence.SIGNIFICANT ACCOMPLISHMENTS:Received BEST PERFORMER OF THE QUARTER award 2014 and 2015Received ENCORE AWARD in the year of 2017QUALIFICATION:Bachelor of Pharmacy (2011) in PRIYADARSHINI COLLEGE OF PHARMACY at RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGLOREDeclaration:I hereby declare that all the details furnished above are true to the best of my knowledge.Place: AtlantaBhavya Tondapu |
