Senior Oncology Clinical Data Management Expert

7 days ago

San Diego, California, United States Alterome Therapeutics Full time

About Alterome Therapeutics

We are a precision oncology biotech company dedicated to developing alteration-specific therapeutics to address high-value and validated oncogenic drivers.

The Company Overview:

  • We aim to inspire hope for those affected by cancer and develop unique therapies that transform their lives.
  • Our vision unites us in our pursuit of developing novel treatments for cancer patients.
  • We strive to create a collaborative work environment where expertise from diverse backgrounds comes together to drive progress.

Salary: $198,000 - $286,000 per year

Job Description:

We seek an Associate Director/Director/Senior Director, Clinical Data Management to join our Oncology Clinical Development team. In this role, you will contribute to the development, planning, and execution of clinical studies, ensuring scientific integrity and interpretation of study data.

Key Responsibilities:

  • Oversee Data Management activities through all study phases for assigned programs or studies.
  • Lead clinical data management oversight of Alterome clinical trials, including project management, CRO oversight, coordination of internal reviews, and approval of day-to-day data management deliverables.
  • Set up data management vendors as required, reviewing RFPs, negotiating data management budgets, and contracts.
  • Liaise with study management CRO and internal cross-functional teams to ensure adequate site training, timely initiation, and overall data integrity.
  • Provide direction and guidance to team members, including consultants and vendors, to achieve study goals and milestones.
  • Oversee database design and post-production updates, ensuring compliance with industry standards and regulatory requirements.
  • Responsible for sponsor user acceptance testing, documenting findings, and resolving issues with CROs.

Required Qualifications:

  • Bachelor's degree with at least 5 years (Associate Director), 8 years (Director), or 10 years (Senior Director) of hands-on data management/CDM experience in the CRO, biotech, or pharmaceutical industry.
  • Oncology experience is required.
  • Hands-on experience leading clinical studies from start-up to database lock and managing multiple programs/studies.
  • Strong vendor oversight experience.
  • Experience managing external data providers, eTMF systems, and inspection readiness activities.
  • Understanding of ICH GCP, 21 CFR part 11, GCDMP, and related regulatory requirements.
  • Expertise in CDISC standards, SAS, SQL, EDC tools, and Microsoft Office applications.

Benefits:

  • Competitive compensation package, including equity.
  • Medical, dental, and vision coverage.
  • Life insurance, 401k with company matching.
  • Paid holidays, flexible time off.
  • Home office setup, full-service gym on-site.
  • Professional development opportunities.
  • Phenomenal company culture.

Location: San Diego, CA, with hybrid schedule requiring three days per week in the office.

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