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Data Entry

Location:
Somerville, Massachusetts, United States
Posted:
January 23, 2018

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Resume:

Manisha Pradhananga

**** ******** ***#*, **********, ma 02144

857-***-**** ac35hp@r.postjobfree.com

Clinical Data

Clinical Data Manager with four years of pharmaceutical experience including data management and clinical trials. Proficient in developing and reviewing various documents involved in the study setup, conduct and close-out phases including Data Management Plan (DMP), Data entry guidelines, Case Report Forms (CRF) completion guidelines and Query resolution and management for paper and EDC studies per Standard Operating Guidelines. Experience in coordinating with vendors and clients, managing teams, and clinical trials throughout the data management lifecycle. Excellent project management, organizational, prioritization and multitasking skills with ability to work independently and in a team to meet timeline and achieve deadlines. Full knowledge of the drug development, study conduct process and regulations related to data management and clinical research.

Professional Experience

Boston Biomedical Inc., Cambridge, MA March 2017 - present

Clinical Data Manager

Collected, managed, reviewed and analyzed clinical data. Closely worked with different sites to complete and update outstanding CRF and to resolve outstanding questions and discrepancies with study data. Ensured clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock.

Proficient in the EDC, Inform and ClinPlus database to collect, clean, monitor, and report data.

Successfully reviewed, developed and effectively implemented database clinical trial data specification, such as, SAS listing review, query logic and data validation.

Ensured consistency and data quality in clinical data by auditing database of each enrolled patient and documenting outcomes and inaccuracy reports.

Developed strategy and content to resolve the issue of missing lab units in the eCaselink for the clinical trial.

Successfully reviewed Response Evaluation Criteria in Solid Tumors and produced error free overall assessment data with extensive knowledge of RECIST criteria.

Performed Medical coding, Serious Adverse Event reconciliation and Lab reconciliation to support ongoing safety review.

Trained and managed clinical data associate, clinical data interns and contractors.

Performed training on study trial for new EDC users.

Successfully organized and executed meetings to prepare study metrics and giving presentation to study team.

Ensured, prepared and cleaned efficacy clinical data for publication and IRB submissions.

Performed UAT to ensure the accuracy, integrity, and quality of data and protocol requirements.

Worked closely and collaboratively with cross-functional teams.

Work closely with EDC vendor to review and design eCRFs that capture all key variables and that are an optimal design for expected patient enrollment and time on study.

Boston Biomedical Inc., Cambridge, MA December 2015 – February 2016

Clinical Data Associate

Created, organized, tracked and monitored CRF tracker and query tracker for phase I and II trails. Prepared and created data entry guideline for paper study.

Worked with clinical sites staff and investigators to obtain study data within a given timeline.

Ensured protocol compliance, and patient safety compliance with the patient-consent process.

Verified that data entered on the eCRFs is consistent with patient clinical notes, known as source data/document verification (SDV), CDQC, discrepancy management, clinical setup documents.

Generated queries to clarify and improve the quality of the data and resolved them or initiated their resolution either by research associate or directly with the investigational site.

Created maintained and tracked EDC user management and other Clinical databases for different clinical trials by collecting master user lists and activated or deactivated user accounts depending upon the request from team members.

Provided support to the Clinical Data Management and Biostatistics team on a study as required performing close out audit for closing of study trial.

Worked with Data Manager to identify the issues associated with the design of CRF and revised the format of CRF.

Effectively imported and exported data with external providers for medical coding of Adverse and Serious Adverse event using World Health Organization Drug Dictionary.

Performed MedDRA coding using Inform Central Coder for Adverse Events.

Boston Biomedical Inc., Cambridge, MA October 2015 – November 2015

Clinical Data Intern

Performed entry, validation, and cleaning of clinical trial data sent from clinical research sites.

Maintained a tracking system for study related information such as CRF expectedness and queries status.

Provides support to the Clinical Data Manager on a study as required to achieve project goals and objectives.

Reviewed clinical trial data and inform data managers about missing, incomplete or implausible data to maintain quality of data.

Communicated with sites and CRA to track a monitoring visit for the study and provide list of monitoring activities that is required to be perform. Such as, source data verification, missing data, queries pending, SAE reconciliations.

Dado Tea, Cambridge, MA August 2010 – September 2015

Manager

Successfully hired, supervised and trained new employees.

Effectively decreased labor costs by analyzing team members' strengths versus customer flow

Consistently exceeded sales goals by providing superior customer service and quality food.

Addressed complaints and resolved problems with both staff and customers.

Assisted customers in selecting merchandise, answering questions and quickly resolving concerns

Maintained inventory, including count verification, reordering and organization.

Bhaktapur Hospital, Bhaktapur, Nepal April 2006 – October 2007

Research Intern

Effectively managed subjects’ confidential information.

Performed drug efficacy analysis on the drug trial.

Performed data entry.

Successfully reviewed patient’s medical records to identify eligible subjects.

Education

Northeastern University, Boston, MA Anticipated 2019

Master of Science in Project Management

Concentration: Clinical Trial

Northeastern University, Boston, MA 2012-2015

Bachelor of Science in Biotechnology

Quincy College, Quincy, MA. 2009-2011

Associate Degree in Natural Science

Technical Skills:

Remote Data Capture System – Electronic Data Capture Tool (e.g. Inform, eCaselink, ClinPlus, Argus).

Microsoft Office, Project, Excel, Word, Work Break structure, Gantt chart, PERT.

Risk and Impact analysis plan.

Creating tasks, Assigning tasks to Resources, Resource allocation.

Risk Management, Cost – minimization, cost- benefit, and cost – effectiveness, and cost utility.

Therapeutic Experience:

Oncology

Honors

Honor Society of Phi Kappa Phi

Dean List

Magna cum laude

2010 and 2011 Scholarship Award – Academic Scholarship

Memberships

Society for Clinical Data Management



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