FSP Manager – Clinical Operations

• Oversee, train, resource, coach, and performance-manage a clinical operations team
• 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 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
• Escalate issues that may affect project deliverables
• Deliver training on WPDs, SOPs, local requirements, and clinical operations
• Identify training gaps and ensure training requirements are met
• Ensure adherence to ethical and regulatory standards
• Alert management to quality issues and request or facilitate QA audits
• Review clinical operations systems including Activate, CTMS, Preclarus, and Clarity to evaluate metrics, KPIs, and project status
• Evaluate staff work, including remote or on-site PAVs
• Participate in process improvement and development initiatives
• Facilitate risk-based monitoring
• Contribute to bids and procurement of new business
• Collaborate with senior management and executive staff on strategic planning and business development
• Lead or contribute to initiatives improving department and company performance

• Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 5+ years
• 1+ year of leadership responsibility
• Appropriate education, training and/or directly related experience may be considered as an equivalency
• 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 skills
• Interpersonal and conflict resolution skills
• Problem-solving skills in a constantly changing environment
• Knowledge of medical/therapeutic areas and medical terminology

• Global team environment
• Collaboration and development opportunities
• Passion, innovation, and commitment to scientific excellence
• Career development support
• Coaching and mentorship
• Training and induction/orientation programs
• Potential participation in process improvement and business development initiatives