Clinical Data Manager

Theradex Oncology is a full-service CRO, conducting early- and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease.

What You'll Do

Hiring a Full time Clinical Data Manager based in the US (Remote-Homebased)

The primary responsibilities of this position include, but are not limited to, the following:

• Perform all Clinical Data Management activities in compliance with SOPs and ICH-GCP regulatory requirements
• Work closely and collaboratively with the SAS Programming team, Biostatistics team and other Data Managers
• Act as lead clinical data manager on multiple studies of moderate complexity with minimal supervision
• Serves as the main point of contact for study DM related matters
• Lead DM Study Start-Up Activities, including:
  • eCRF Development and Review
    • Ensure adequate data collection per protocol requirements and consult with project management, medical monitoring, biostatistics, and  statistical programming teams as needed
    • Ensure design is configured in compliance with CDISC standards
    • Organize and actively participates in internal and client eCRF review meetings
  • Edit Check Configuration
  • Electronic Data Capture (EDC) study build
  • Data Listing Development
  • Preparation of eCRF Completion Guidelines and ensuring completion of site training
  • Development and maintenance of Data Management Plan (DMP)
  • Development of Data Transfer Agreement(s) (DTAs) with external vendors
• Conduct EDC User Acceptance Testing and program validations
• Develop programs in SAS/EXCEL for study data metrics monitoring and clinical data reviews
  • Refers to Statistical Analysis Plan and TLF Plan to configure adequate data checks to ensure high quality, analysis-ready data
• Perform comprehensive data review of all patient data through:
  • Query management
  • Review of Programmatic checks
  • Manual data review as needed
  • Reconciliation of SAEs with pharmacovigilance group
  • Reconciliation of external data transfers with clinical database
  • Identification of missing/delinquent data
  • Coordination with Medical Monitors to resolve any medical review data issues
• Perform WHO Drug Dictionary coding and MedDRA coding as necessary
• Support Project Team through:
  • Tracking and provision of project status updates to project managers for monthly project team meetings
  • Close communication with CRA’s to identify and mitigate negative data trends/issues
  • Provision of listings/reports as needed
  • Create ad-hoc reports for special data requests from Sponsor
• Ensure that documentation is maintained in a state of constant audit-readiness and filed in the Trial Master File.
• Coordinate all activities in preparation for study milestones and database lock
• May assist in the mentoring of less experienced employees
• Manage and prioritize project deliverables per established study timelines

What You Need

• Bachelor’s degree required / Master’s degree preferred
• 3+ years relevant data management experience in the CRO / pharmaceutical industry required
• EDC experience preferred, RAVE EDC experience preferred
• SQL/SAS programming experience preferred

Skills and Competencies

• Demonstrates knowledge of GCPs and protocol
• Strong understanding of CDISC CDASH and SDTM Standards
• Highly effective ability to anticipate problems relating to projects and to develop and implement solutions
• Excellent interpersonal skills
• Fluent knowledge of written and verbal English
• Highly organized and result-oriented
• Strong communication, comprehension and logic skills
• Ability to work independently with minimal supervision as well as in a team environment
• Proficient in Word and Excel
• Ability to understand high level programming languages
• Strong time management and prioritization skills to meet deadlines among multiple projects

What we offer

We offer a supportive culture that puts people first. We provide a competitive compensation and benefits package including medical, dental, vision, life insurance, STD/LTD, company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and much more.   

Theradex is an Equal Opportunity Employer.