Manager, Clinical Operations – FSP

• 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 through coaching, mentorship and work direction
• Conduct performance appraisals and career discussions
• Facilitate employee career development
• Interview, recruit and select staff
• Manage and conduct induction and orientation programs for new employees
• Maintain complete and up-to-date staff CVs, training records, position profiles and experience profiles
• Ensure accurate and timely timesheets and expense reports
• Support allocation activities and project leads/functional leads to optimize project operations
• Escalate issues that may impact project deliverables
• Deliver training on WPDs, SOPs, local requirements and other clinical operations subjects
• 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 quality assurance audits
• Review clinical operations systems including Activate, CTMS, Preclarus and Clarity to evaluate employee and project metrics, KPIs and project status
• Evaluate staff work, including remote or on-site PAVs, monitoring skills and project conduct
• Participate in process improvement and development initiatives
• Ensure understanding and facilitation of risk-based monitoring
• Contribute to bids and procurement of new business as required
• Collaborate with senior management and executive staff on strategic planning and business development
• Lead or contribute to initiatives improving department or company-wide performance

• Previous experience providing knowledge, skills, and abilities 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 proficiency including data entry, archival and retrieval
• Ability to travel as needed
• Team-building skills
• Interpersonal and conflict-resolution skills
• Problem-solving skills applicable to a constantly changing environment
• Knowledge of medical/therapeutic areas and medical terminology

• Global team environment at Thermo Fisher Scientific
• Collaboration and development opportunities
• Opportunity to contribute to scientific excellence and innovation