Associate Director, Study Start Up (Site Budgets & Contracts)
Core
Global subject-matter lead for investigator site budgets and clinical trial agreements (CTAs) across an oncology portfolio, ensuring rapid site activation and defensible Fair Market Value (FMV).
Role type
Senior IC clinical operations manager (site budgeting & contracting)
Builds
Site budgets, CTAs, and study start-up plans for oncology clinical trials
Domain
Biopharmaceuticals / Oncology clinical trials
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Site budget development from protocols, CTA negotiation, FMV rationale, global budget template creation, cycle-time metric analysis, CRO/vendor oversight, ICH-GCP compliance
Preferred skills
Oncology Phase 1-3 protocol experience, US coverage/MCA analysis, feasibility benchmarking (Citeline/TrialTrove), global CTA playbook development, clinical research certification (ACRP/SoCRA/PMP)
Technologies
IQVIA GrantPlan, Veeva Vault Clinical (CTMS/eTMF)
Responsibilities
Interpret clinical protocols to build procedure-level site budgets; lead budget and payment-term negotiations with investigator sites; drive rapid CTA execution to meet activation targets; analyze cycle-time metrics to forecast and accelerate site activation; oversee CRO and outsourced contracting vendors; coach and develop study start-up team members
Seniority
Senior, hands-on IC with leadership responsibilities
