Director/Senior Director Clinical Data Management
Get AI-powered advice on this job and more exclusive features.
Crescent Biopharma’s vision is to build a world-leading oncology company bringing the next wave of therapies for cancer patients. The company’s pipeline includes a PD-1 x VEGF bispecific antibody and novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies for a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the company on LinkedIn and X.
Position Overview
The Director/Senior Director of Clinical Data Management, reporting to the VP of Clinical Development Operations, will oversee all clinical data management activities for Crescent’s clinical studies. This high-impact role involves leading data management for Crescent’s lead asset, CR-001, and scaling the department, defining strategies, and establishing efficient operating models. Responsibilities include creating data processes and standards, ensuring seamless data integration and quality from electronic data capture (EDC) systems and other sources, and developing data reporting metrics, dashboards, and analytics.
Responsibilities
* Oversee all Data Management activities for the CR-001-101 clinical study, including vendor management for EDC, IRT, and data visualization providers.
* Develop and review study plans and protocols to ensure data collection and CRF design meet study objectives, including validation and transfer plans.
* Establish standards for CRF development, database build, validation, edit checks, and system integration to enable near-real-time data access.
* Ensure deliverables meet departmental and company goals.
* Prepare for audits and inspections by maintaining data quality and ensuring CDISC compliance.
* Provide expertise during all project phases, including audits and external inspections.
* Manage development and review of SOPs, WIs, and templates, and assess metrics for improvements.
* Generate performance metrics, reports, dashboards, and analytics for the Clinical Data Management team.
* Represent clinical data management at meetings, build vendor relationships, and review proposals.
* Interact effectively with senior management across functions.
Education & Experience
* BS/BA in science, biology, mathematics, or computer science; CCDM preferred.
* Knowledge of MedDRA, WHODrug, and data standardization.
* Proficiency in Excel, relational databases, SQL, and data manipulation tools like SAS, R, or Python.
* 15+ years in clinical trial data management, with oncology and Phase I experience.
* Experience managing CROs and reviewing clinical data.
* Hands-on experience with EDC systems (e.g., Rave) and CDISC/CDASH standards.
* Experience with data visualization tools (Spotfire, Tableau, RShiny, Dash).
* Biomarker data management and programming skills are a plus.
What We Offer
* Impactful work in a mission-driven team with growth opportunities.
* Competitive salary, performance bonus, and equity.
* Employer-paid benefits, flexible PTO, and annual shutdowns.
* Resources and mentorship for professional development.
Crescent Biopharma is an Equal Opportunity Employer committed to diversity and inclusion. Employment is based on qualifications and merit, regardless of protected statuses.
Seniority level
* Director
Employment type
* Full-time
Job function
* Health Care Provider
#J-18808-Ljbffr