Clinical Data Management Lead And Training Specialist

Statistics & Data Corporation (Sdc) Tempe , AZ 85280

Posted 3 weeks ago

Job Summary:

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). Works closely with Managers to establish training curriculum and delivery. Mentors/trains Clinical Data Managers and Clinical Data Analysts.Primary Responsibilities:

  • Performs 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 within industry and departmental standards; works closely with Principal Clinical Data Managers on training needs and delivery
  • 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; works closely with Project Management department to communicate training needs and coordinate curriculum
  • 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 SDCs quality system
  • Comply with SDCs data integrity and business ethics requirements
  • Contribute to overall company training focus and initiatives
  • Assist in the creation and management of training materials
  • Develop training curriculum and coordinate the implementation of training for new employees
  • Perform other duties as assigned

Required Skills:

  • Exceptional working knowledge of clinical trials and the data management role in the clinical trials process
  • Outstanding communication and mentoring skills
  • 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
  • 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, ophthalmology, cardiology, central nervous system (CNS), infectious disease, respiratory, endocrinology, gastroenterology

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Education or Equivalent Experience:

  • Masters degree (preferably in engineering, applied or life science) and at least three (3) years of experience in clinical data management including leading several clinical studies, or a Bachelors degree (preferably in engineering, applied or life science) or equivalent education and work experience with a minimum of four (4) years of experience in clinical trials, or current Certified Clinical Data Manager (CCDM) status and four (4) years of experience in clinical trials.
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Clinical Data Management Lead And Training Specialist

Statistics & Data Corporation (Sdc)