Lead Data Manager - SCDM 2020 conference included

Harbor Clinical - Cambridge, MA

Temporary | Contract

Harbor Clinical is seeking an experienced senior data manager to oversee data management across multiple clinical trials. GI and Rare Disease Experience a huge plus. The ideal candidate will be responsible for data management leadership and providing metrics and reports to executive leadership to ensure the collection of clinical trial data is accurate, complete and within stated timelines.

Harbor believes in continuous education for its team and this position includes paid attendance for the SCDM 2020 conference in San Antonio along with SCDM membership.

Role Details and Requirements:

  • Serve as an active member of Study Teams
  • Work with other functions to manage timelines and ensure that clinical data management deadlines are met
  • Liaise with third-party vendors such as CROs and central laboratories in support of timelines and data-related deliverables
  • Work with database builders to develop EDC databases, edit checks and reports
  • May define database and edit check specifications to support the protocol and analyses
  • Participate in database testing in accordance with UAT Plan
  • Create and maintain data management documentation
  • Regularly review and query clinical trial data as indicated in the Data Validation
  • Help design listings in support of data management, clinical and medical reviews of data
  • Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics, audit reports, and input from project team members and other stakeholders
  • Train other personnel on study-related items and data management principles, as needed
  • Ensure coordination with Pharmacovigilance on adverse event reconciliation
  • Review and provide feedback on draft protocols, Statistical Analysis Plans, CSRs and other documents as required
  • Other duties as assigned

Role Qualifications:

  • Bachelor’s degree
  • 7 + years of experience in clinical data management in clinical research industry
  • Oncology therapeutic experience
  • Proficiency in the areas of clinical data collection, cleaning and analysis
  • Experience working in cross-functional team-oriented settings
  • Shows strong project management skills
  • Comprehension of ICH and regulatory environment as it pertains to data management
  • EDC system experience (e.g. Rave, InForm, DataLabs)
  • Knowledgeable of how data management actions impact other functional areas & deliverables
  • Experience with SDTM and C-DASH
  • Experience with medical coding dictionaries (MeDRA, WHODRUG)

Job Types: Temporary, Contract

Experience:

  • relevant: 5 years (Preferred)

Education:

  • Bachelor's (Preferred)

Work Location:

  • One location

Employment Length:

  • 4 - 6 months
  • Varies

This Job Is Ideal for Someone Who Is:

  • Dependable -- more reliable than spontaneous
  • People-oriented -- enjoys interacting with people and working on group projects
  • Detail-oriented -- would rather focus on the details of work than the bigger picture