Associate Director, Clinical Operations (Study Startup)

Job Overview

The Associate Director is 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 to build and maintain strong client relationships and mutually beneficial long-term partnerships. Participates in the hiring, training, resource allocation/utilization, performance management, audits, systems, etc. to ensure operational excellence of startup services while contributing to company goals/objectives.

Key Job Accountabilities

• Lead and oversee clinical study startup teams and project start up activities to ensure high-quality, timely, and compliant execution aligned with sponsor expectations, protocols, SOPs, and regulatory requirements.

• Partner with Clinical Operations Leads, Project Managers, sponsors, and cross-functional teams to develop and execute effective startup strategies that support study timelines and enrollment goals.

• 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.

• Lead and contribute to project teams’ feasibility assessment activities and site selection strategies by evaluating site capabilities, patient access, competing studies, and operational risks.

• Monitor project startup timelines, KPIs, cycle times, and quality metrics; proactively identify operational risks, escalate issues appropriately, and implement mitigation strategies.

• Oversee and support site contract and budget negotiation activities to drive timely execution and effective collaboration with investigational sites and sponsors.

• Provide leadership, mentoring, and line management for Clinical Trial Assistants and Site Contracts/Budgets teams to ensure operational excellence and staff development.

• Plan, hire, train and mentor Clinical Operations personnel and perform staff performance management and career development planning.

• Lead Everest clinical operations, therapeutic leads and commercial teams to build and maintain strong relationships with investigators, study sites, sponsors, and vendors to support efficient startup execution and long-term partnerships.

• Perform business analysis and benchmarking within start up services and identify opportunities for continuous improvement and adoption of technologies and tools to improve performance and productivity.

• Drive continuous improvement initiatives across startup operations, including process optimization, standardization, quality improvements, and adoption of technology-enabled solutions.

• Author governing documents (SOPs, Checklists, templates, etc.) as required.

• Support inspection readiness and ensure startup activities comply with ICH-GCP, regulatory requirements, sponsor expectations, and internal quality standards.

• Participate in sponsor meetings, bid defenses, Requests for Proposal (RFP) activities, and operational governance discussions as a startup subject matter expert.

• Continue to build client relationships and grow the Everest brand.

• Contribute to the development and maintenance of SOPs, work instructions, templates, guidance documents, and training materials related to startup operations.

• Prepare for and participate in internal audits, sponsor audits, and regulatory inspections; support implementation of corrective and preventive actions, as required.

• Foster a collaborative, positive, accountable, high-performing, and client-focused culture and work environment while leading the definition and execution of broader Clinical Operations annual objectives with corporate goals.

Qualifications and Experience

• Must have at least a bachelor or master’s degree in science, health studies and research fields, or equivalent with 14 years of clinical research experience.

• Requires 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 with ability to interact successfully and communicate effectively with personnel at all levels within the organization and with client contacts.

• Exceptional written communication and presentation skills.

Travel Level Specification

This position may require 20% to 50% business travel.

Benefits & Compensation

• We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a 401(k) retirement, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.

Estimated Salary Range

$165,000 - $210,000.