Note: The job is a remote job and is open to candidates in USA. Everest Clinical Research is a full-service contract research organization providing expertise-based clinical research services. The Associate Director, Clinical Operations will work with the Clinical Operations team to ensure high-quality startup services, build client relationships, and oversee project activities during the startup phase.
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
Skills
- 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
- 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
- The opportunity to earn a performance based bonus
Company Overview