Director, Third Party Data Acquisition
Takeda
Google Cloud PlatformSDLC
Senior Manager, Clinical Data Management
Generate Biomedicines
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Act as the lead data manager for assigned clinical trials from start-up through database lock.
- Review and implement data management documentation such as Data Management Plan (DMP), CRF design and CRF Completion Guidelines, edit check specifications, and data review and discrepancy management guidelines.
- Lead database build and UAT for EDC platforms (e.g., Medidata Rave).
- Drive data cleaning activities to ensure database quality and readiness for interim/final analyses including regular review of metrics, data issues and update slides for team meetings.
- Monitor data reconciliation activities with external vendors (e.g., labs, ECG) and Serious Adverse Events (SAE).
- Oversee CRO/vendor performance and ensure adherence to timelines and data quality expectations.
- Collaborate with cross-functional teams (clinical operations, biostatistics, safety, programming) to ensure alignment on data flow and delivery milestones.
- Create and manage data deliverable timelines and tasks; collaborate with CROs to manage timelines and deliverables for data management activities.
- Maintain and QC study-specific trackers and metrics dashboards.
- Support or lead database freeze/lock processes, including freeze/lock for final, statistical or interim reviews.
- Assist in departmental development, review, and revision of Data Management Standard Operating Procedures (SOPs), plans and guidelines.
- Recommend process improvements, tools, or automation opportunities to enhance data management efficiency.
Requirements
- B.S with 7 + years or M.S. 5 + years of experience in Clinical Data Management at CRO/pharma/biotech.
- 5+ years of progressive experience/expertise with Medidata Rave EDC and eTMF.
- Prior consulting or contract experience preferred.
- Knowledge of regulatory standards (ICH-GCP, FDA, EMA) and data standards (CDISC).
- Strong understanding of clinical trial lifecycle and data flows.
- Exceptional communication, time management, and problem-solving skills.
- Ability to work independently with minimal supervision in a remote or cross-functional environment.
- Excellent interpersonal and communication skills.
- Nice to have: Experience supporting IND submissions.
- Nice to have: Familiarity with data management tools.
- Nice to have: Therapeutic area experience (e.g., oncology, infectious disease, immunology).
- Nice to have: Experience supporting global trials and working with international teams.
- Nice to have: Familiarity with Risk-Based Monitoring (RBM), centralized monitoring, and ePRO/eCOA platforms.
