Associate Director, Clinical Operations – Study Startup

Job not on LinkedIn

🕒 May 15

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $165k - $210k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

💊 Pharmaceuticals

🧬 Biotechnology

🤝 B2B

Pharmaceuticals • Biotechnology • B2B

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 Description

• responsible for working with the Clinical Operations team to deliver high-quality, client-centered, and profitable approaches to clinical startup services • proactively drives projects during the startup phase and interacts with clients as a startup subject matter expert • build and maintain strong client relationships and mutually beneficial long-term partnerships • lead and oversee clinical study startup teams and project start up activities • partner with Clinical Operations Leads, Project Managers, sponsors, and cross-functional teams to develop and execute effective startup strategies • actively drive study startup performance across site identification, feasibility, site selection, ethics/regulatory submissions, site activation, contract and budget negotiations, and essential document collection • ensure quality and completeness of startup deliverables by performing reviews of regulatory submissions, essential documents, startup trackers, and study records • monitor project startup timelines, KPIs, cycle times, and quality metrics • provide leadership, mentoring, and line management for Clinical Trial Assistants and Site Contracts/Budgets teams • perform business analysis and benchmarking within startup services and identify opportunities for continuous improvement

🎯 Requirements

• at least a bachelor or master’s degree in science, health studies and research fields, or equivalent • 14 years of clinical research experience • experience in business and operational management • broad-based business operations experience in clinical research environment, preferred in the Clinical Research Organization industry • Very good industry reputation with a wide customer base of contacts • Proven experience in leading an organization to optimum performance and contributions • Exceptional people management skills • Exceptional written communication and presentation skills • Travel level specification: this position may require 20% to 50% business travel

🏖️ Benefits

• medical, dental, and vision coverage • life & AD&D insurance • short- and long-term disability • tuition reimbursement • fitness reimbursement • employee assistance program (EAP) • 401(k) retirement • generous paid time off and sick leave • performance based bonus