Lead Clinical Data Operations: Own the end-to-end data lifecycle for our clinical studies. Establish timelines and drive team adherence towards interim analysis data cuts, database locks and final validation readouts
Sample & Data Reconciliation: Manage the complex reconciliation between clinical data (EDC) and biological sample data (LIMS). Ensure the life-cycle of the sample matches the clinical data
Data Quality & Regulatory Readiness: Own, execute, and oversee compliance with the Clinical Data Management Plan (CDMP). Author and oversee the generation of Data Quality Review listings (DQR) to support IVD clinical validation. Ensure all clinical data activities are inspection-ready. Proactively organize and perform ongoing data review throughout study conduct to ensure timely and appropriate identification of errors, trends, discrepancies, completeness, and quality issues
Ensure proper closeout and archiving of data management study related materials, e.g., CDMPs, database change documentation, validation documents, and final participant casebooks
Vendor Oversight: Manage CROs and EDC vendors to ensure they meet DELFI’s standards, study-specific plans, and contractual obligations. Review eCRF designs, edit checks, and UAT specifications to minimize downstream data issues
Cross-Functional Leadership: Serve as a primary data management representative in clinical study team meetings. Develop and maintain departmental procedures in accordance with regulatory requirements Proactively assess project and CDM issues and risks working with the Clinical Operations team
Mentorship: While this role is an individual contributor, a critical function will be to provide oversight to deliverables of junior team members

Requirements

Clinical Trial Expertise: 10+ years of Clinical Data Management experience (or 8+ with an advanced degree), ideally at a Sponsor company within an IVD or Medical Device environment. You have led data management for multiple studies from protocol design to submission and have expert-level knowledge of Electronic Data Capture systems.
Regulatory Depth: Expert knowledge of GCP, ICH, CDISC/SDTM. You have a deep understanding of what inspection-ready data looks like and how to deliver it.
Technical Comfort: You are "Data Savvy." You may not be a software developer, but you are comfortable writing SQL to query a database and have exposure to R or Python for data review. You prefer a notebook environment over an Excel export.
Execution Focus: You have a track record of hitting aggressive database lock timelines without compromising quality via strong cross-functional collaboration. You have partnered with and led CRO data management teams and understand how to partner with vendors to ensure high quality, on-time deliverables.

Benefits

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Applicant Tracking System Keywords

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

Hard Skills & Tools

Clinical Data ManagementElectronic Data CaptureSQLRPythonData Quality ReviewClinical Data Management PlanData ReconciliationDatabase LockInspection-Ready Data

Soft Skills

Cross-Functional LeadershipMentorshipProject ManagementCollaborationProblem SolvingCommunicationOrganizational SkillsAttention to DetailRisk AssessmentTeam Management

Certifications

GCP CertificationICH CertificationCDISC Certification