Manager, Clinical Operations FSP – EMEA

• Oversee, train, resource, coach and performance-manage a clinical operations-focused team
• Lead performance using metrics and key performance indicators
• Escalate performance concerns and training needs
• Collaborate with leadership on resourcing needs
• Manage staff and provide coaching, mentorship and work direction
• Conduct performance appraisals, career discussions and employee development
• Interview, recruit and select staff
• Manage induction and orientation programs for new employees
• Maintain staff CVs, training records, position profiles and experience profiles
• Ensure accurate and timely timesheets and expense reports
• Support allocation activities and project/functional leads to optimize project operations
• Raise 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
• Assure adherence to ethical and regulatory standards
• Alert management to quality issues and facilitate quality assurance 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 initiatives
• Ensure understanding and facilitation of risk-based monitoring
• Provide input into 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 department and company-wide performance or process improvement initiatives

• Previous experience comparable to 5+ years
• 1+ year of leadership responsibility
• Equivalency through 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
• Ability to learn and apply 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, interpersonal and conflict resolution skills
• Advanced problem-solving skills in a constantly changing environment
• Knowledge of medical/therapeutic areas and medical terminology

• Global team environment
• Collaboration and development opportunities
• Scientific excellence-focused work environment