Associate Director, Clinical Operations (Study Startup)

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham Ontario, Canada with additional locations in: Bridgewater, New Jersey; Shanghai, China; Taipei, Taiwan; and multiple offices in Europe.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as an Associate Director, Clinical Operations.

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 pension, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.

Estimated Salary Range: $165,000 - $210,000.