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Associate Manager, Clinical Operations

About the role

• Oversee, train, resource, coach and performance-manage a team of clinical operations staff
• Lead performance using metrics and key performance indicators
• Act as point of escalation for performance concerns and training needs
• Collaborate with leadership on resourcing needs
• Manage staff and provide coaching, mentorship and work direction
• Conduct performance appraisals and career discussions; facilitate employee career development
• Interview, recruit and select staff
• Manage and conduct induction/orientation programs for new employees
• Maintain complete and current staff CVs, training records, position profiles and experience profiles
• Ensure timely and accurate timesheets and expense reports
• Support allocation activities and project/functional leads to optimize project operations
• Raise issues that may impact project deliverables
• Deliver training on WPDs, SOPs, local requirements and other clinical operations topics
• Identify training gaps and ensure training requirements are met
• Assure adherence to ethical and regulatory standards
• Alert management to quality issues and request or facilitate QA audits
• Review systems including Activate, CTMS, Preclarus and Clarity to evaluate employee and project metrics, KPIs and project status
• Evaluate staff work, including conducting remote or on-site PAVs when applicable
• Participate in process improvement and development initiatives
• Ensure understanding and facilitation of risk-based monitoring
• Provide input into bids and procurement of new business when required
• Collaborate with senior management and executive staff on strategic planning and business development
• Lead or contribute to initiatives enhancing department performance and company-wide process improvement

• Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 5+ years
• 1+ year of leadership responsibility
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• Advanced mentoring, leadership and supervisory skills
• Excellent clinical trials monitoring skills, both remote and on-site
• Understanding of or ability to learn company SOPs, WPDs and relevant regulations, including ICH/GCP and FDA guidelines
• Ability to evaluate medical research data
• Strong organizational and negotiation skills
• Strong attention to detail
• Advanced written and oral communication skills
• Good knowledge of English language and grammar
• Computer skills including data entry, archival and retrieval
• Ability to travel as needed
• Team-building, interpersonal and conflict-resolution skills
• Problem-solving skills in a constantly changing environment
• Knowledge of medical/therapeutic areas and medical terminology

• Fully remote work arrangement
• Standard Monday-Friday work schedule
• Coaching, mentorship and career development opportunities
• Training and professional development
• Global team collaboration
• Scientific excellence and innovation-focused work environment