Director, Data Management - Clinical Trials
Overview
You will own clinical data management for late-phase cardiovascular trials, overseeing CROs and vendors from start-up to database lock. Reporting to the Head of Biometrics, you will set standards, mentor junior staff, and drive quality and timeliness across a matrixed team. This role demands 10+ years of CDM experience and expertise with EDC systems like Rave, CDISC standards, and GCP compliance. You will shape processes, manage budgets, and ensure trial data meets regulatory standards. Join a clinical-stage biotech where your work directly impacts cardiovascular therapies.
What You'll Do9
- 1Oversee CRO and external vendors (central lab, ePRO/eCOA, IRT) for all CDM activities across one or more late-phase trials.
- 2Lead cross-functional review of eCRF design, EDC user acceptance testing, and related specifications, manuals, and guidelines.
- 3Ensure CDM activities comply with GCP, GCDMP, and internal SOPs while meeting regulatory requirements.
- 4Develop and maintain study-level Data Management Plans (DMPs) and oversee medical coding conventions (MedDRA, WHO Drug Dictionary).
- 5Build and maintain data management SOPs, contributing to team-building and mentoring contractors and junior staff.
- 6Support resource planning, budget forecasting, and issue resolution for ongoing trials.
- 7Identify process improvements and evaluate biometrics tools to enhance speed, quality, and output.
- 8Assume biometrics project lead for assigned trials, integrating and overseeing biometrics teams and external vendors.
- 9Partner across the matrix to establish data management standards and processes, applying strong problem-solving skills.
Requirements13
- 1Bachelor's degree required; Master's degree a plus.
- 210+ years of data management experience in clinical trials, with 2+ years in matrix management.
- 3Experience managing Data Management CROs.
- 4Experience running phase II/III trials, with cross-functional collaboration and high-quality data delivery within timelines and budget.
- 5Demonstrated ability to manage multiple concurrent trials and competing priorities in a fast-paced biotech environment.
- 6In-depth understanding of drug development, study conduct through electronic submission, Biometrics processes from Protocol to Clinical Study Report, and industry-standard data dictionaries and questionnaires/clinical outcome assessments.
- 7Knowledge of regulations: GCP, ICH guidelines, EU directives, 21CFR Part 11, and GCDMP.
- 8Experience with CDISC (CDASH and SDTM).
- 9Hands-on experience with mainstream EDC systems, preferably Rave.
- 10Familiarity with data visualization tools (Spotfire, Tableau, or similar).
- 11Cardiovascular clinical trials expertise a plus.
- 12Experience developing and implementing CDM standards.
- 13Strong leadership, communication, and problem-solving skills in a matrixed environment.
Salary Insight
$220 - $235k per year
Location
Required Skills
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