Associate Director, Clinical Data Management
BridgeBio
full-time
Posted on:
Location Type: Hybrid
Location: United States
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Salary
💰 $173,600 - $212,400 per year
Job Level
About the role
- Interfaces with study team, vendors, and sites to ensure that data management activities are performed consistently, and deliverables are of high-quality
- Represents Data Management in study team meetings and facilitates cross-functional activities as the DM lead or DM point of contact for study
- Performs and/or Coordinates the ongoing data review activities, including identification, tracking and resolution of data issues
- Leads data management timelines and deliverables, including metric output, are detailed and communicated to the study team on a regular basis
- Participates in the oversight of external data reconciliation (e.g., IxRS, safety, central and specialty labs, patient reported outcomes, etc.)
- Participates in the oversight of data transfers and review/approval of documentation of Data Transfer Plans for study
- Authors, reviews and/or approves various study related documents and plans (e.g., Data Management Plans, eCRF Specifications, Edit Check Specifications, eCRF Completion Guidelines, Data Transfer Plans, etc.) and ensures documents are maintained throughout the duration of the study
- Participates and/or oversees database development (e.g., CRF development, edit check development, User Acceptance Testing, etc.)
- Coordinates the clinical data review listings, reporting of metrics, and adhoc requests · Contributes to the conduct of clinical data review and preparation for DMC, DSUR, Database Freeze, Database Lock and/or other data deliverables
- Participates in vendor selection, including RFPs and bid defense meetings, as applicable · Maintains a working knowledge of study protocols and any amendments
Requirements
- Minimum of 8 years of Data Management experience in the pharmaceutical and/or biotech space, as a lead role
- Bachelor’s degree or equivalent
- Experience with mentoring or supervising junior staff
- Experience working with a CRO and/or mentoring/supervising junior staff
- Experience as Data Management Lead in all phases of clinical trials
- Experience with external vendor oversight
- Previous experience working with an Electronic Data Capture system (EDC)
- Proficient with MS Word, Excel and PowerPoint
Benefits
- Market leading compensation
- 401K with 100% employer match on first 3% & 50% on the next 2%
- Employee stock purchase program
- Pre-tax commuter benefits
- Referral program with $2,500 award for hired referrals
- Comprehensive health care with 100% premiums covered - no cost to you and dependents
- Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
- Hybrid work model - employees have the autonomy in where and how they do their work
- Unlimited flexible paid time off - take the time that you need
- Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
- Flex spending accounts & company-provided group term life & disability
- Subsidized lunch via Forkable on days worked from our office
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
data managementdata reviewdata reconciliationdatabase developmentUser Acceptance Testingclinical trialsElectronic Data Capturementoringsupervising
Soft Skills
communicationleadershipcoordinationproblem-solving