
Associate Director, Clinical Data Management
Bicara Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Boston • Massachusetts • United States
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Salary
💰 $190,000 - $220,000 per year
Job Level
Tech Stack
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