Clinical Data Management Expert

5 days ago


Boston, Massachusetts, United States KCR Full time

Job Title: Clinical Data Management Expert - US Team

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About the Role:

We are seeking a highly skilled and experienced Clinical Data Management Expert to join our US team. In this role, you will play a critical part in advancing drug and vaccine development programs by overseeing all aspects of data management activities.

Key Responsibilities:

  • Lead, plan, and execute data management tasks for assigned projects, ensuring data integrity, validity, and reliability.
  • Develop, generate, and analyze project status and/or metric reports, summarizing findings and remediation activities to internal and external stakeholders.
  • Hold vendor oversight and management with respect to data management deliverables, ensuring selected vendors meet service level commitments.
  • Participate in new project cost estimates, proposal review, proposal defense, and capabilities presentations with minimal oversight.

Requirements:

  • Bachelor's degree in life sciences/pharmacy/biotechnology, nursing from an accredited US College/University.
  • At least 5 years of professional data management experience, preferably in pharmaceutical, biotechnology, or CRO industry with recent CRO experience given top priority.
  • Experience with Oncology study data, other Therapeutic areas beneficial.
  • Strong knowledge of monitoring guidelines, SOPs, GCP/ICH, and applicable Guidelines.
  • Deep knowledge of late-stage clinical data management process; study start-up/execution/database lock.
  • Expert computer systems literacy, and adaptable to new technologies.
  • Experienced user with multiple data collection systems including electronic data capture (EDC) technologies such as ePRO or eCOA, IRT, and at least one EDC tool such as Veeva CDMS, Medidata Rave, InForm, Oracle Clinical, Clincase, etc.
  • Excellent professional command of English language, written and spoken.
  • Ability to execute tasks in an accurate and timely manner with an emphasis on quality, organization, coordination, and project management.

About KCR:

KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations. Founded in 1997, our expert teams support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting, and Placement. We operate across North America, Europe, and Australia, with main office locations in Boston, US, Berlin, Germany, Madrid, Spain, and Warsaw, Poland.

What We Offer:

  • $90,000 - $120,000 per year, depending on experience
  • 33 PTO days + 1 additional day for your birthday
  • A valuable healthcare and wellbeing benefits package
  • Loyalty and Referral Programs
  • Onboarding process and induction training
  • The latest technology and most advanced equipment
  • An open culture based on slim processes, agile structure, and direct access to Management
  • Mentoring and training programs related to clinical trials and therapeutic areas

Contact Information:



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