Clinical Data Manager
Veristat
Etobicoke, Ontario
2d ago

Description

Veristat is expanding our presence from our home office in Boston, up to Montreal and Toronto, and down in Research Triangle Park.

We do things differently than large CROs. Do you value scientific integrity and a collaborative team environment? If so, you will feel right at home here with dedicated opportunities to discuss your achievements and grow your career through quarterly managerial conversations.

We invite you to learn more about us at our website.

The Clinical Data Manager is responsible for the performance of data management tasks from study start-up, inclusive of database design, through database lock for assigned projects within electronic data capture (EDC) systems.

S / he is responsible for the creation of CRFs, programming of edit checks, facilitating User Acceptance Testing (UAT), data cleaning, query generation and management, and development of relevant data management documents.

The Clinical Data Manager is responsible for overall data quality and documentation, and may lead a small team of support roles from within data management to achieve these goals.

The Clinical Data Manager will work on small to mid-sized projects in various indications.

As a Clinical Data Manager You Will

  • Lead studies as the Lead Data Manager or support other lead team members with ongoing project work, as determined by business need and relevant skillset
  • Liaise between study personnel and the client, as appropriate, regarding clinical and / or technical issues
  • Develop and / or review case report forms (CRFs) within EDC system
  • Author or perform quality control review of data management documents, such as CRF Completion Guidelines (CCGs), Data Management Plans (DMP), and Data Transfer Plans
  • Develop or quality control review Data Validation Specifications (DVS) documents
  • Participate in programming edit checks and other system functions within EDC as needed
  • Facilitate or participate in User Acceptance Testing (UAT) prior to study go-live
  • Responsible for data Cleaning activities including data review, query generation and management, and development of study metrics.
  • May find discrepancies, track trends, and identify areas of retraining needed from members of the study team.

  • Perform reconciliation activities of external data (e.g., Central Labs, IVRS, etc.)
  • Oversee or participate in database Lock activities, including managing user access and authoring or providing quality control review of lock documentation.
  • Partner with the other functional groups (e.g., Biostatistics, Statistical Programming, Medical Writing, Project Management, etc.
  • to ensure data management aspects of the project are properly considered and integrate well with the other activities

    Experience + Requirements

  • Bachelor’s degree in a related field & 2 years of experience in clinical data management required OR Master’s degree & 1 years of experience in clinical data management.
  • 1 year of experience in leading small project teams preferred.
  • Working knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
  • Skilled in use of computer technology, including clinical trial databases and applications (e.g., IBM Clinical Development, Medidata RaveX) and ability to learn new applications.
  • Excellent interpersonal, communication, and organizational skills with the ability to work both independently and in a team environment.
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