Bicara Therapeutics

Associate Director, Clinical Data Management

Bicara Therapeutics

full-time

Posted on:

Location Type: Hybrid

Location: BostonMassachusettsUnited States

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Salary

💰 $190,000 - $220,000 per year

Job Level

About the role

  • Review and manage DM activities in vendor proposals and budgets
  • Function as internal DM Study lead, overseeing data management activities performed by CROs
  • Review and manage key documents such as data management plan and CRF completion guidelines
  • Provide DM level review on all study medical coding
  • Oversee eCRF design and annotation, database design specifications
  • Participate in user acceptance testing (UAT) of the clinical database
  • Lead internal study team in data review
  • Define/oversee data transfer specifications for external data sources
  • Collaborate with SAS and clinical systems programming to produce data reports
  • Mentor other data management personnel.

Requirements

  • Bachelor’s degree in Life Sciences, Health Informatics, or a related field
  • Minimum of 5 years of experience in clinical data management
  • Oncology experience required
  • Proficiency with EDC systems (e.g., Medidata Rave, Oracle Clinical)
  • Strong knowledge of ICH-GCP guidelines
  • Excellent organizational, analytical, and problem-solving skills
  • Ability to work independently and as part of a team
  • Strong communication skills, both written and verbal.
Benefits
  • Health insurance
  • Retirement plans
  • Flexible work arrangements
  • Professional development

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
data managementclinical data managementmedical codingeCRF designdatabase designdata transfer specificationsuser acceptance testingdata reportinganalytical skillsproblem-solving skills
Soft skills
organizational skillscommunication skillsteamworkindependencementoring