Company:  Confidential

Job Title: Clinical Data Manager

Job Number: 22404

Location: New York, NY

Job Description

The Clinical Data Manager will report to the Chief Medical Officer and will be responsible for leading internal and outsourced Data Management activities in support of our clinical trials. This includes managing Case Report Form (CRF) requirements, contributing to establishing defined company data standards and conventions, coordination of centralized data review activities, and is accountable for data integrity, quality, and consistency at database lock. The successful candidate will be a key interface with our contract research organizations (CROs) for any data management-related activities. Knowledge of Industry and regulatory standards (CDISC, SDTM) with an ability to translate clinical team objectives into operational actions and maximizing the current technical platforms will be a heavily leveraged skill set

Responsibilities

  • Provide leadership and content expertise for Clinical Data Management activities from start-up through statistical analysis stage of clinical studies to effectively manage data capture, review, and database lock activities.
  • Participate in protocol review and ensure all protocol elements are accurately captured in the database
  • Manage data activities for all clinical trials as well as the design, review, and validation of the clinical database
  • Oversee or lead the design of case report forms (CRFs) as well as data management plans, data edit checks and aggregate check specifications with CROs, data transfer agreements and specifications, SDTM mapping, CRF completion guidelines, Manual Review Guidelines, or Data Entry guidelines
  • Oversee all external consultants and other data vendors with respect to key performance indicators, metrics, and program level deliverables and timelines. Assess metrics for vendor quality and efficiencies, and escalate issues as needed
  • Oversee the development of any clinical database by the eDC/CRO vendor and manage the Sponsor user acceptance testing of the clinical database
  • Review or perform external data reconciliation (i.e. laboratory data), and SAE reconciliation
  • Proactively organize and perform on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors, trends, discrepancies, completeness, content, and quality issues
  • Ensure proper closeout and archiving of data management study related materials, i.e. DMPs, database change documentation, validation documents, and final patient casebooks in paper or electronic format
  • Proactively assess project and CDM issues and risks working with the Clinical Operations team
  • Propose resolutions and mitigations to the Clinical Operations team and track issues and risks through to completion
  • Define and monitor CDM related scope, cost, time and quality for all DM deliverables expected from CRO from project start up to close out
  • Train sites at investigator meetings and data management staff on study database
  • Represent Data Management as the lead contract and liaison on the clinical research team

Required Skills

  • 8+ years of Clinical Data Management experience in biotech/pharma or CRO industry; BS in scientific/healthcare discipline
  • EDC experience – Medidata RAVE and IBM experience; Medidata core-configuration; management experience
  • Excellent verbal, written, interpersonal and presentation skills are required
  • Working knowledge and experience with Word, PowerPoint and Excel
  • Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials
  • Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures
  • Ability to develop tools and processes that increase measured efficiencies of the project
  • Must be able to anticipate obstacles and proactively develop solutions to achieve project goals
  • Must have a general understanding of functional issues and routine project goals from an organizational perspective
  • A successful candidate will have clinical experience with rare/Orphan disease products and/or gene therapy clinical trials

 

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