Senior Clinical Data Manager
Remote Worker - N/A
Job Type
Full-time
Description

JOB SUMMARY

The Senior Clinical Data Manager manages all data relating to various studies.

RESPONSIBILITIES

  • Provide leadership and guidance to the data manager and data coordinator.
  • Create, track, and manage data management timelines, proposals, and budgets.
  • Provide support and act as the data management point person to the Sponsor, CROs, vendors, clinical sites, and scorers
  • Develop and maintain good communications and working relationships with Clinilabs project team members as well as Sponsor, CRO, vendor, and clinical site project team members
  • Develop presentations and present at Investigator meetings
  • Train, track, and manage users (Sponsors, Sites, Investigators and other study personnel) on the CDMS
  • Manage delivery of projects through full data management process life-cycle, including but not limited to:
  • CRF/eCRF design from protocol
  • Creation of CRF/eCRF Completion Guidelines
  • Database design, set-up, acceptance testing in the CDMS
  • Creation of the study Data Management Plan and Edit Check Specifications
  • Edit check programming and/or validation in the CDMS
  • Perform study change control as needed
  • Manage and oversee both site and internal data entry and query resolution
  • Perform data reviews
  • Generate requested data management reports
  • Perform query generation/tracking and oversee query resolution
  • Perform and oversee vendor data imports and transfers
  • Perform and oversee MedDRA and WHODrug coding
  • Perform database lock activities
  • Creation, completion, organization, and tracking of all data management documentation
  • Determine project and department resource needs and data management responsibilities
  • Consult with supervisors for process issues and communicate ideas for process improvement
  • Assist in developing and implementing new technology
  • Develop, edit, and review Standard Operating Procedures and Work Instructions as needed
  • Oversee, track, and document both internal training (e.g. Standard Operating Procedures/Work Instructions, study-specific training) and external training (e.g. site CRF and EDC training)
  • Follow and ensure compliance with current Good Clinical Practices (cGCPs)
  • Adhere to corporate policies and procedures
  • Other duties as assigned

TRAVELING

No travel required

Requirements
  • The position requires at least a Bachelor’s Degree in clinical, biological, or mathematical sciences with minimum of 7 years of experience in Clinical Data Management in Clinical Trials.
  • At least 3 years of working experience on Medidata RAVE platform, build EDC in Medidata RAVE or equivalent EDC platform. Certified RAVE builder is a plus.
  • Comprehensive experience with at least one clinical data management system (CDMS) including direct experience and/or understanding with database design, set-up and user acceptance testing; edit check development and/or programming and validation; management of data entry and queries; and study change control.
  • Thorough knowledge of all data management processes from study start-up to study close-out.
  • Knowledge of medical terminology, pharmacology, anatomy, and physiology.
  • Previous experience and proven competence in managing delivery of projects through full data management study life-cycle (Phase I, Phase II and Phase III).
  • Comprehensive understanding of clinical drug development processes.
  • Excellent computer, organizational, and communication skills.
  • Experience working on both paper and electronic data management studies.
  • Direct experience designing and creating paper and a clear understand of electronic Case Report Forms (CRFs/eCRFs).
  • Experience performing SAE Reconciliation.
  • Experience with performing user acceptance testing and validation and associated documentation.
  • Experience with creating and managing data management proposals and budgets.
  • Good Clinical Practices training.
  • Experience with the following preferred but not required:
  • Medrio (CDMS)
  • Adobe InDesign software
  • Microsoft Access
  • SQL
  • MedDRA
  • WHODrug

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