10/13/2026
Associate Director, Clinical Study Management
Northern, NJ
Role Overview
The Associate Director of Clinical Study Management for international regions oversees the ex*****on of global clinical trials in oncology and other core therapeutic areas. This hybrid role requires an onsite presence a minimum of 3 days per week to drive operational excellence, manage trial delivery, and support strategic team expansion and cross-functional alignment.
You will partner closely with cross-functional Clinical Research and Development teams to ensure trials meet target timelines, stay within budget, and adhere to the highest standards of quality and patient safety.
• Onsite Requirement: Minimum 3 days per week in office (Regional Hub options available)
• Therapeutic Focus: Oncology, or related clinical fields
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Core Responsibilities
• Study Ex*****on & Leadership:
o Lead trial deliverables, timelines, and protocol ex*****on across international regions (EMEA/LATAM) to satisfy country commitments and regulatory frameworks.
o Operate with minimal oversight from senior leadership, collaborating seamlessly across Clinical Operations and R&D functions.
o Provide direction to cross-functional study teams to guarantee smooth trial operations from start-up to close-out.
• Compliance & Quality Assurance:
o Ensure all clinical trials comply with approved protocols, ICH-GCP standards, and local/regional health authority regulations (e.g., EMA, PMDA, and national bodies).
o Oversee documentation accuracy and timely filing across electronic trial master files (e.g., Veeva TMF), regulatory, safety, and financial tracking systems.
o Maintain adherence to internal standard operating procedures (SOPs), clinical/ancillary supply chains, import/export rules, and insurance protocols.
• Vendor & Resource Management:
o Manage non-CRO vendor relationships, contracts, performance metrics, and deliverables regarding time, cost, and quality.
o Partner with finance, legal, external partners, and clinical sites to track major milestones.
o Handle regional resource allocation, budget forecasting, financial tracking, and key performance indicators (KPIs).
• Team Building & Strategy:
o Lead, recruit, mentor, and manage regional clinical operations and study management personnel.
o Provide regular progress reports to senior stakeholders across Clinical Operations, Project Management, and Portfolio Strategy.
o Contribute to high-level departmental initiatives and process-improvement projects.
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What You Bring
• Background & Experience:
o Minimum of 10 years of related industry experience with a Bachelor’s degree, or 8 years with an advanced/postgraduate degree.
o Extensive hands-on experience managing multi-center, global clinical trials (Phases I–IV) with deep familiarity with regional operational nuances.
o Proven track record of managing trial budgets, headcount, resources, and cross-functional project delivery.
• Knowledge & Skills:
o Comprehensive command of ICH-GCP guidelines and regional regulatory frameworks for EMEA and LATAM.
o Fluency in English (strong written and verbal communication); proficiency in additional EMEA or LATAM languages is a distinct advantage.
o High sense of accountability, problem-solving flexibility, and a proactive "growth mindset."
o Ability to balance independent ex*****on with team leadership in a fast-paced environment.
Please contact Darren Gutowski at [email protected]
