Start-up Manager, FSP

• Manage complex site operations and support compliance with regulatory standards
• Support site recruitment and training efforts
• Facilitate collaboration between trial sites and internal teams
• Collaborate in a matrix environment to deliver site activation within assigned projects
• Oversee site activation according to timelines and quality standards
• Coordinate information flow between PPD teams, clients, and functional departments
• Develop project implementation plans and guidelines using PPD tools
• Monitor and analyze project status and provide metrics to upper management
• Identify risks and provide contingency planning
• Manage financial and contractual aspects of studies related to site activation
• Establish controls to align project resources and expenses with budgets
• Administer technical and operational aspects of site activation, including feasibility, site contracts, and country teams
• Manage assigned scope of work against timelines, costs, and quality
• Identify and evaluate issues affecting successful site activation and implement solutions
• Develop customer relationships aligned with assigned projects

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience comparable to 5+ years
• Equivalent combination of appropriate education, training and/or directly related experience may be considered
• Ability to work efficiently with cross-functional teams
• Knowledge of cross-functional project management principles
• Organizational and multitasking skills
• Attention to detail
• Ability to identify and remedy risks related to contractual deliverables
• Cross-cultural awareness and adaptability
• Understanding of clinical research/development, medical and therapeutic areas, study phases, and medical terminology
• Ability to lead, liaise with, and coordinate cross-functional project teams
• Knowledge of clinical development guidelines and Directives
• Ability to access and use computer software
• Ability to communicate and understand information presented through spoken words and sentences
• Ability to perform under stress and multitask
• Regular and consistent attendance
• Ability to work in an office/laboratory and/or clinical environment
• Ability to use personal protective equipment including protective eyewear, garments, and gloves
• Ability to work upright and/or stationary for 6–8 hours per day
• Ability to perform repetitive hand movements
• Frequent mobility; occasional crouching, stooping, bending, and twisting
• Ability to lift and carry 15–20 lbs

• Global team environment
• Collaboration and development opportunities
• Occasional travel to domestic and international site locations