Talent.com
Contract Data Management Team Lead

Contract Data Management Team Lead

Clark Davis AssociatesJersey City, NJ, US
job_description.job_card.variable_hours_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

A leading, innovative biopharmaceutical company is seeking a Data Management Lead for one or more complex clinical development projects. This role is responsible for delivering high-quality, timely clinical data management outputs that support the company's growing development portfolio.

This is a hybrid position requiring a minimum of 3 days per week onsite in Jersey City, NJ or New York, NY . (NO REMOTE APPLICANTS)

Responsibilities

  • Serve as the primary clinical data management lead for assigned clinical studies, ensuring alignment on data collection requirements and timelines.
  • Oversee end-to-end data management activities, including planning, coordination, and delivery of reliable, high-quality clinical trial data.
  • Manage and provide oversight of third-party vendors delivering data management services.
  • Lead the development, review, and approval of DM study documents, including Data Quality Management Plans, Data Validation Plans, and eCRF Completion Guidelines.
  • Chair Data Review meetings and drive ongoing review of trial data for quality and completeness.
  • Partner with cross-functional study teams, providing input on EDC setup (Veeva CDMS preferred), eCOA, RTSM, and other data collection systems.
  • Ensure adherence to data standards (CDASH / CDISC) and quality expectations.
  • Support regulatory submissions (NDA, BLA, MAA) and represent data management during audits / inspections.
  • Mentor and provide quality oversight for junior Data Management Leads.

Qualifications

  • Postgraduate degree with 8+ years or bachelor's degree with 10+ years in Life Sciences, Biostatistics, Computer Science, or related discipline.
  • Proven clinical data management experience in sponsor, CRO, or vendor settings across multiple phases, indications, and geographies.
  • Oncology experience required.
  • Strong knowledge of FDA / ICH guidelines, CDASH / CDISC standards, and industry best practices.
  • Proficiency with EDC systems (Veeva CDMS preferred) and familiarity with eCOA, RTSM, and external data integrations.
  • Excellent project management, vendor oversight, and cross-functional collaboration skills.
  • Strong communication skills with the ability to influence across functions and levels

    • Seniority level

  • Mid-Senior level

    • Employment type

  • Full-time

    • Job function

  • Research, Quality Assurance, and Project Management

    • Industries

  • Pharmaceutical Manufacturing
  • Biotechnology Research
  • Hospitals and Health Care

    • J-18808-Ljbffr

    serp_jobs.job_alerts.create_a_job

    Data Management Lead • Jersey City, NJ, US