Associate Director Clinical Operations

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

Associate Director / Senior Clinical Trial Manager | Oncology

I'm working with a clinical-stage oncology biotech developing next-generation antibody-drug conjugates for hard-to-treat solid tumours. They are well funded by top-tier specialist investors and are now expanding their early-phase/ FIH Programs!

What you'll own

• Clinical operations for one or more clinical-stage programmes, from start-up to close-out
• Shaping early and late-phase development strategy, then making it happen
• Key study documents: synopses, protocols, ICFs, IBs, CSRs
• Site start-up, leading both in-house and CRO-driven activity
• CROs, sites and specialist vendors, held to timelines, budget and quality
• Clinical systems set-up: EDC, eTMF, central reading, central and speciality labs
• Quality, compliance and inspection readiness under ICH/GCP

What you'll bring

• 5+ years in clinical operations (pharma, biotech or CRO), with 3+ years managing vendors
• Oncology and early phase drug development experience
• Hands-on site start-up expertise; site-level background strongly preferred
• Strong ICH/GCP and EU guidelines knowledge, plus inspection experience
• A track record of leading cross-functional teams without a big support structure

Why this one stands out

• Cutting-edge modality, novel science, lead asset already dosing patients
• A pipeline that gives you room to grow as the company does
• Strategic influence, not just execution
• Small, experienced team where your impact is visible from day one

Level is flexible (Senior CTM or AD) depending on experience.