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Job: Senior Clinical Data Manager

This posting has expired and is no longer available.

Job Description

Oversees and coordinates all data management activities in support of clinical and/or non-clinical research studies for study initiation, set up, maintenance, and close out. Manages the day-to-day data management project activities including, but not limited to timelines, budgets, staff, project scope, reports and communication for the lifecycle of the project(s). Mentors/trains Clinical Data Managers and Clinical Data Analysts.

Primary Responsibilities:

  • Spearhead study setup including CRF design, database structure development, annotation, document creation and/or approval, data entry screen and edit check testing and approval, etc.
  • Proactively plan, allocate and prioritize workloads for multiple projects (to include media control, data entry, pre-entry review and discrepancy management and assessment tasks, as applicable)
  • Working independently to oversee day to day data management project activities
  • Establish, monitor and maintain timeline for data management responsibilities
  • Mentor clinical data managers and clinical data analysts
  • Assist other CDMs and CDAs with the management of tasks, timelines and budgets as they pertain to data management activities on projects
  • Communicate with cross functional groups throughout the project lifecycle
  • Plan and conduct internal and external team meetings
  • Participate in presentations to clients, sites, and cross functional groups
  • Monitor project budget and project scope, as they relate to data management activities, and communicate project status regularly to senior management
  • Provide project team with regular updates on project progress pertaining to data management activities
  • Assume full project management responsibility for all data management activities
  • Train site coordinators, Clinical Research Associates, and investigators on clinical data entry, discrepancy management, CRF page verification, and CRF page approval processes
  • Develop, maintain, and analyze assigned project metrics such as completed pages, discrepancy aging, etc. Establish causes and implement corrective actions for adverse trends that are identified.
  • Maintain quality control of the clinical data, project deliverables and closeouts
  • Oversee the review of medical coding for validity and completeness
  • Adhere to all aspects of SDC’s quality system
  • Comply with SDC’s data integrity and business ethics requirements
  • Perform other duties as assigned

Skills / Requirements

Required Skills:

  • Exceptional working knowledge of clinical trials and the data management role in the clinical trials process
  • Excellent organizational and project management skills
  • Good knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations
  • A minimum of 3 years staff mentoring and leadership experience
  • Outstanding leadership capabilities
  • Strong delegation abilities
  • Highly effective written and verbal communication skills in English
  • Technical skills with EDC systems, CDMS and other relational databases, and Microsoft Office products
  • Desirable skills include: CRF design, MS Project, involvement with a federal submission (either NDA or PMA), programming skills (SAS, PL/SQL), analytical capabilities, medical coding (adverse events and medical therapies)
  • Experience in multiple therapeutic areas (TAs) in clinical trials is mandatory including experience in at least two of the following TAs: oncology, cardiology, central nervous system (CNS), infectious disease, respiratory, endocrinology, gastroenterology


Education or Equivalent Experience:

Master’s degree (preferably in engineering, applied or life science) and at least three (3) years of experience in clinical data management, or a Bachelor’s degree (preferably in engineering, applied or life science) or equivalent education and work experience with a minimum of five (5) years of experience in clinical trials, or current Certified Clinical Data Manager (CCDM) status and five (5) years of experience in clinical trials.