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Elpida Therapeutics · 23 hours ago

Clinical Data Management Lead / Clinical Data Manager

United States

Full-time

Remote

Senior Level

5+ years exp

Elpida Therapeutics is a mission-driven biotechnology organization advancing clinical programs for rare and ultra-rare diseases. They are seeking a Clinical Data Management Lead to provide leadership and hands-on execution across global clinical trials, ensuring data quality and compliance with regulatory expectations.

BiotechnologyGeneticsTherapeutics

Hiring Manager

Terry Pirovolakis

Responsibilities

Lead end-to-end clinical data management activities from study start-up through database lock and archival

Serve as the primary sponsor point of contact for all data management deliverables

Represent Data management in cross-functional study team meetings, proactivitely communicating risks, timelines, and mitigation strategies

Manage and track data management timelines, ensuring alignment with overall study milestones

Review study protocols to ensure appropriate data capture strategies, CRF design, and integration of external data sources

Lead CRF design and review to ensure protocol alignment and compliance with CDASH standards

Oversee EDC system setup, database builds, migrations, version control, and release (REDCap Cloud strongly preferred)

Plan, execute, and document User Acceptance Testing (UAT), including defining test scope, programming checks, issue tracking, and approvals

Support site and system training setup and delivery, ensuring complete and inspection-ready documentation

Define, document, and oversee data validation checks implemented within the EDC and externally (e.g., SAS-based checks)

Perform ongoing review of data quality metrics, query trends, and data listings

Conduct periodic data entry quality and source verification in collaboration with Clinical Operations

Oversee reconciliation of safety data with Pharmacovigilance partners

Oversee reconciliation of external data sources, including laboratories, imaging, biomarkers, and other vendor data

Oversee and review medical coding for adverse events and concomitant medications using MedDRA and WHODrug

Ensure all data management documentation is complete, current, and TMF-ready at all times

Author, review, and maintain key study documents including: Data Management Plans, CRFs and database specifications, data transfer and reconciliation plans, and coding conventions and laboratory data handling plans

Author and maintain data management SOPs and related procedures applicable to statistics and programming

Ensure compliance with ICH-GCP, FDA, EMA, and 21 CFR Part 11 requirements

Provide sponsor oversight of CROs and service providers delivering data management services

Monitor vendor performance, timelines, and quality metrics

Participate in vendor selection, scope definition, budget forecasting for outsourced data management activities

Maintain effective working relationship with CROs, EDC vendors, and external data providers

Support statisticians and statistical programming with clean, analysis-read data for interim analyses, CSRs, and regulatory submissions

Serve as primary Data Management point of contact during FDA and EMA inspections and audits

Prepare, present, and respond to regulatory inquiries related to data integrity and data management processes

Lead development and implementation of CAPAs for data management-related inspection findings

Support training and mentoring of employees in data management activities, as needed

Contribute to departmental SOPs, templates, and process improvements

Qualification

Clinical data managementEDC systems (REDCap Cloud)GCPICHFDAEMA complianceMedical coding MedDRAMedical coding WHODrugData validation checksDocumentation disciplineProcess improvementsCommunication skillsTeam mentoring