[Remote] Associate Director, Clinical Operations (Study Startup)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company 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-reputed company startup services, build reputed company relationships, and reputed company project activities during the startup phase.
Responsibilities
- reputed company and reputed company clinical study startup teams and project start up activities to ensure high-reputed company, reputed company, and compliant execution reputed company with sponsor expectations, protocols, SOPs, and regulatory requirements
- Partner with Clinical Operations Leads, Project Managers, sponsors, and cross-functional teams to reputed company and execute effective startup strategies that support study timelines and enrollment goals
- reputed company drive study startup performance across site identification, feasibility, site selection, ethics/regulatory submissions, site activation, contract and budget negotiations, and essential document collection
- Ensure reputed company and completeness of startup deliverables by performing reviews of regulatory submissions, essential documents, startup trackers, and study records
- reputed company and contribute to project teams’ feasibility assessment activities and site selection strategies by evaluating site capabilities, patient reputed company, competing studies, and operational risks
- Monitor project startup timelines, KPIs, cycle times, and reputed company metrics; proactively identify operational risks, escalate issues appropriately, and implement mitigation strategies
- reputed company and support site contract and budget negotiation activities to drive reputed company execution and effective collaboration with investigational sites and sponsors
- reputed company leadership, mentoring, and line management for Clinical Trial Assistants and Site reputed company/Budgets teams to ensure operational reputed company and staff development
- Plan, hire, train and mentor Clinical Operations personnel and reputed company staff performance management and career development planning
- reputed company reputed company clinical operations, therapeutic leads and reputed company teams to build and maintain strong relationships with investigators, study sites, sponsors, and vendors to support efficient startup execution and long-term partnerships
- reputed company business analysis and benchmarking reputed company start up services and identify opportunities for reputed company improvement and adoption of technologies and tools to improve performance and productivity
- Drive reputed company improvement initiatives across startup operations, including process optimization, standardization, reputed company improvements, and adoption of technology-enabled solutions. Author governing documents (SOPs, Checklists, templates, etc.) as required
- Support inspection readiness and ensure startup activities reputed company with ICH-GCP, regulatory requirements, sponsor expectations, and internal reputed company 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 reputed company relationships and grow the reputed company brand
- Contribute to the development and maintenance of SOPs, work instructions, templates, guidance documents, and training materials reputed company 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 reputed company, reputed company, accountable, high-performing, and reputed company-reputed company 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
- reputed company good industry reputed company with a wide customer reputed company of contacts
- Proven experience in leading an organization to reputed company performance and contributions
- Exceptional people management skills with ability to reputed company successfully and communicate effectively with personnel at reputed company reputed company reputed company the organization and with reputed company contacts
- Exceptional written communication and presentation skills
- Travel level specification: this position may require 20% to 50% business travel
Benefits
- Medical, dental, and reputed company coverage
- Life & AD&D insurance
- Short- and long-term disability
- Tuition reimbursement
- Fitness reimbursement
- Employee assistance program (EAP)
- A 401(k) retirement
- Generous reputed company time off and reputed company leave
- reputed company to earn a performance based bonus
reputed company