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clinical data manager ii resume example with 9+ years of experience

Jessica Claire
, , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
Home: (555) 432-1000 - Cell: - resumesample@example.com - -
Professional Summary

Dedicated to using excellent research, respected professional with 6years experience in Clinical Data Management, and 3years experience as a Clinical Research Associate. I investigation and project management abilities to optimize management, organization and reporting of Clinical Data. Results-driven, precise and systematic with quick learning and collaborative nature, annotating Case Report Forms (CRF's)

Skills
  • User Access Management
  • Database Upgrades, Data Collections
  • Accounts Payable and Accounts Receivable
  • Clinical Data Review
  • Records Management Systems
  • Clinical Documentation Management
  • Data Capture (SQL)
  • Data Cleaning, Data Input
  • MS office (Word, PowerPoint, Excel, Outlook, Access) Oracle Clinical, Medidata RAVE, Medrio, Open clinical, INFORM
  • Payment Collection, Task Prioritization
  • Quality Control Procedures
  • Create CRF Completion Guidelines
  • Research and Data Management
  • User Acceptance Testing (UAT)
Work History
01/2022 to Current
Clinical Data Manager II Bd (Becton, Dickinson And Company) Andover, MA,

• Coordinate and communicate with DB vendors on consistent basis to address Clinical team's requests, and project plans.

• Ability to independently lead study-start up, database update and database lock activities.

• Collaborate with study teams, cross-functional team members, and external partners.

• Reviewed all uncoded medical terms and coded them based on MedDRA and WHO dictionaries.

• Oversight and management of external DM and data vendors, and related deliverables.

• Built and deployed plans, reports, validation procedures and entry processes for data management needs.

• Developed and provided edit check, query logic specifications for development of CRF’s and performed UAT using written user acceptance rest scripts.

• Performed data cleaning in various projects at same time and managed in handling multiple priorities under tight timeline.

• Design and implement templates and or systems (e.g.), databases and spreadsheets) for tracking essential key data related activities with 3rd party vendors.

• Performed ongoing QA of documents filed in electronic Trial Master File (TMF)

• Assisted in performing data cleaning for Phase III studies in Oncology.

• Ability to oversee and lead as needed in DM related tasks such as: SAE reconciliation, external data reconciliation, medial monitoring and coding review, cross-functional data review, and study or program related deliverable review.

02/2016 to 10/2021
Clinical Date Manager ALIGN CRO City, STATE,
  • Draft CCGs and DMP, and sign-off on the Data Management Plan.
  • Participated in committees to discuss electronic health records and methods to improve overall workflows.
  • Drive the use of data standards (CDISC) and Also conduct UAT
  • Exceeded goals through effective task prioritization and great work ethic.
  • Work with Database Engineer to create the EDC database specifications.
  • Utilized data regarding industry trends to shape solutions and approaches.
  • Attended and participated study specific meetings as applicable.
  • Assisted with database upgrades and migrations by performing user acceptance testing.
  • Collected, reviewed and analyzed data from diverse departments for needs.
  • Used critical thinking to break down problems, evaluate solutions and make decisions.
  • Performed ongoing QA of documents filed in electronic Trial Master File (TMF)
03/2013 to 12/2015
Clinical Research Associate SAVANTE CONSULTING LIMITED City, STATE,
  • Advocates for advancement of critical strategic objectives that promote effective, efficient, and compliant management of clinical studies with focus in commercial INDs/IDEs
  • Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
  • Independently tracking, planning, ensuring research activities are conducted in accordance with approved protocols and reporting monitoring activities.
  • Developing project specific monitoring plans via evaluation of project risk and in accordance with FDA guidance, monitoring for multiple clinical trials
  • Proven IT proficiency and skills including Microsoft Office
  • In-depth knowledge of ICH-GCP guidelines, and applicable regulations, rules and guidance, as applicable.
  • Working knowledge of clinical biomedical and/or behavioral research
  • Set up and disbanded trial study centers to manage clinical study activities for 4 sites.
Education
Expected in 10/2010
Bachelor's Degree: Business Administration And Management
Delta State University - Delta State, Nigeria,
GPA:

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Resume Overview

School Attended

  • Delta State University

Job Titles Held:

  • Clinical Data Manager II
  • Clinical Date Manager
  • Clinical Research Associate

Degrees

  • Bachelor's Degree

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