Associate, Clinical Development Operations and Project Management
Core
Support the day-to-day running of RB042 clinical trials alongside CROs and vendors, maintaining integrated program plans, timelines, budgets, and risk logs for a clinical-stage biotech.
Role type
Associate Clinical Development Operations and Project Management
Builds
Clinical trials for RB042 (inhaled SSO for COPD) and broader SSO pipeline
Domain
Biotechnology / Clinical Development / Respiratory Therapeutics
Required skills
Clinical trial operations (study start-up, conduct, close-out), ICH-GCP compliance, TMF management, CRO/vendor coordination, budget tracking, project management (timelines, risks, meetings), Excel, PowerPoint, scheduling tools
Preferred skills
Respiratory/inhaled drug-device studies, oligonucleotide programs, start-up biotech experience, multi-country trials, CAPM/PRINCE2 certification
Technologies
CTMS, EDC, MS Project, Smartsheet
Responsibilities
Support study start-up, conduct, and close-out; Track site activation and recruitment milestones; Prepare and review study documents (protocols, ICFs, study plans); Oversee sponsor TMF and support inspection readiness; Coordinate clinical supply and device logistics; Support vendor selection, contracting, and invoice reconciliation; Maintain integrated development plan and timeline; Run cross-functional team meetings; Track program risk and issue registers; Track budgets and prepare variance reports; Prepare program status updates for leadership
Seniority
Early career, hands-on IC