Sr. Clinical Data Manager in Virtual / Travel

$80K - $100K(Ladders Estimates)

Whiz Finder Corporation   •  

Virtual / Travel

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 66 days ago

  by    Jenny Ann Nunez

This job is no longer available.

Job Summary

Title: Sr. Clinical Data Manager

Company: Medical Device

Location: Minneapolis, MN

Type: Permanent Role

Notes: No Corp to Corp


Job Description:


  • Leads aspects of data management including, but not limited to:
  • Designing CRF's, CRF completion guidelines, database user requirements, technical requirements;
  • Creating data management plans;
  • Performing ongoing data review, medical coding, e.g., of adverse events, medical history; or concomitant medications;
  • Coordinating and facilitating User Acceptance Testing (UAT);
  • Reviewing protocol and clinical study reports for data management content;
  • Creating and maintaining tools for efficient management of the project;
  • Creating or reviewing all other data management-related study documents and validation efforts;
  • Overseeing data validation efforts, including plan and report generation, staff training, validation oversight and corrections.
  • Managing study records related to Data Management responsibilities for the Trial Master File.
  • Develops, validates and maintains databases in accordance with customer and regulatory requirements
  • Recommends solutions to internal project teams and RCRI clientele as necessary.
  • Interprets and implements 21 CFR, Part 11 requirements.
  • Participates in establishing and maintaining Clinical Trial Management (CTMS) and/or electronic regulatory binder features and functionality and new module features and functionality (e.g., safety, adjudication, device accountability, monitoring) standardization.
  • Develops and maintains project timelines and budgets and reports any issues to project manager.
  • Analyzes and reports all study issues to supervisor, project manager, and/or sponsor, as appropriate.
  • Works with Biostatisticians and clinical project managers to define reports, edit checks, new database features, etc.
  • Interacts with Biostatisticians and clinical project managers to further RCRI's use of database features and modules.
  • Serves as database user expert.
  • Ensures compliance with RCRI and applicable sponsor SOPs.
  • Assists in the creation and management of internal training, data standardization and/or SOPs.
  • Participates in client meetings, as necessary.
  • Attends applicable internal and external training programs each year.
  • Contributes to Business Development activities, as required, which may include, but not be limited to:
  • Actively marketing RCRI data management services to current and potential clients;
  • assisting in marketing efforts of RCRI services and database solutions to current and potential clients;
  • assisting in the preparation of client proposals and work orders, and attending bid defense meetings.
  • May perform dual roles as Project Manager, as necessary.


Responsibilities:


  • Science, IS, health-related, or technical bachelor's degree.
  • Minimum of five years of data management and/or clinical experience preferred with at least three specifically in data management.
  • Excellent communication and interpersonal skills.
  • Strong organizational skills.
  • Detail-oriented.
  • Ability to travel up to 20% time preferred.
  • Experience with clinical systems, including data management, EDC, and Clinical Trial Management Systems (CTMS) experience is required.
  • Database development and/or validation experience is required.
  • Highly proficient with MS Office. Solid understanding of software capabilities and business applications.
  • Ability to independently handle multiple tasks and prioritize with minimal oversight.

Valid Through: 2019-9-12