Strategic Oncology Clinical Operations Director

Elixir Associates LTD; Massachusetts; On-site; USD 140,000 - 210,000; Full time

Job summary

Elixir Associates LTD in Massachusetts seeks an Associate Director / Senior Clinical Trial Manager in Oncology. You will lead clinical operations for multiple early-stage programmes, shaping development strategy and ensuring delivery from start-up to close-out.

Responsibilities include site start-up, vendor management, EDC/eTMF setups, and compliance with ICH/GCP. Collaborate with CROs, sites and vendors to meet timelines, budget and quality.

Qualifications

• 5+ years in clinical operations or pharma/biotech/CRO with vendor management.
• Experience in oncology and early phase drug development.
• Hands-on site start-up and vendor coordination experience.
• Strong knowledge of ICH/GCP and regulatory guidelines.

Responsibilities

• Clinical operations for one or more programmes from start-up to close-out.
• Shape development strategy and execute it across phases.
• Manage study documents: synopses, protocols, ICFs, IBs, CSRs.
• Oversee site start-up, in-house and CRO activities.
• Coordinate CROs, sites and vendors to meet timelines, budget and quality.
• Lead clinical systems setup (EDC, eTMF, labs).
• Maintain quality and inspection readiness per ICH/GCP.

Skills

Vendor management

Cross-functional leadership

Site start-up

ICH/GCP knowledge

Oncology & early phase

Tools

EDC

eTMF

Central labs

Job description

Elixir Associates LTD in Massachusetts seeks an Associate Director / Senior Clinical Trial Manager in Oncology. You will lead clinical operations for multiple early-stage programmes, shaping development strategy and ensuring delivery from start-up to close-out.

Responsibilities include site start-up, vendor management, EDC/eTMF setups, and compliance with ICH/GCP. Collaborate with CROs, sites and vendors to meet timelines, budget and quality.