Associate Director, Clinical Operations (Study Startup)

Everest Clinical Research•,

2d•$165,000 - $210,000•Hybrid

About The Position

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. 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 for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA or Canada in accordance with our Work from Home policy. 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.

Requirements

At least a bachelor or master’s degree in science, health studies and research fields, or equivalent with 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 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.

Responsibilities

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.