Associate Director, Clinical Operations (Study Startup)

Everest Clinical Research; Markham; On-site; GBP 122,040 - 155,324; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Tuition reimbursement

Employee assistance program

Job summary

Everest Clinical Research in Markham, UK is seeking an Associate Director to lead clinical study startup teams, ensuring compliance and quality in deliverables. This role involves significant client interaction and operational management to drive project success.

The ideal candidate will have at least 14 years in clinical research, exceptional leadership and communication skills, and a strong reputation in the industry. A diverse benefits package and a salary range of $165,000 - $210,000 are offered.

Qualifications

• 14 years of clinical research experience.
• Experience in business and operational management in clinical research.
• Exceptional written communication and presentation skills.

Responsibilities

• Lead and oversee clinical study startup teams.
• Ensure quality and completeness of startup deliverables.
• Monitor project startup timelines and quality metrics.

Skills

Leadership

Communication

Operational management

Client relationship management

Education

Bachelor or master’s degree in science, health studies, or research fields

Job description

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 aAssociate Director, Clinical Operations.

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, elevate 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 execute 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 startup 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 a clinical research environment, preferably in the CRO 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 the 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.

Experience and Hiring

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.