Job Title: Associate Director / Director, Clinical Operations

Work Location: EST-Remote

Summary:

This contract role is responsible for the hands-on management and execution of global Phase II clinical trials in rare disease and oncology, with a focus on direct CRO oversight and operational excellence. The position requires a seasoned clinical operations professional who thrives in a fast-paced environment and is adept at managing complex studies from startup through close-out.

Responsibilities:

• Lead and oversee all phases of clinical study execution, from site feasibility through study closure, utilizing a risk-based approach.
• Directly manage CROs and vendors, including the development and review of eCRFs, study manuals, plans, and procedures.
• Collaborate with cross-functional teams in Clinical, CMC, Research, Regulatory Affairs, Legal, and Finance to ensure seamless study operations.
• Project manage the creation and amendment of protocols, informed consent forms (ICFs), and site budgets, including review and approval processes.
• Develop training materials and matrices for vendors and clinical sites, and ensure proper maintenance of training records.
• Oversee the electronic Trial Master File (eTMF) and ensure all study documentation is maintained in compliance with regulatory standards.
• Identify, resolve, and escalate issues impacting study execution, implementing corrective actions as necessary to maintain timelines and quality.
• Support regulatory filings, attend site visits as needed, and provide mentorship and onboarding for internal team members.

Qualifications:

• Bachelor’s degree in health or life sciences or equivalent experience.
• 7+ years of clinical operations experience in pharmaceutical, biotech, or CRO settings, including direct CRO management.
• Demonstrated leadership and interpersonal skills, with experience guiding and developing team members.
• Proven ability to work independently and collaboratively, adapting to changing priorities and deadlines.
• Strong analytical and problem-solving abilities.
• Comprehensive knowledge of GCP and ICH guidelines.
• Proficiency with Microsoft Office Suite, Electronic Data Capture, and Trial Master File systems.
• Ability to travel up to 30% as required.

Published Category: Clinical Operations & Development