Start-up Manager, FSP

• Manage complex site operations and ensure compliance with regulatory standards
• Support site recruitment and training efforts
• Facilitate collaboration between trial sites and internal teams
• Coordinate site activation delivery within assigned projects in a matrix environment
• Oversee site activation according to project timelines and quality standards
• Coordinate information flow between PPD teams, clients, and functional departments
• Develop recommended project implementation plans and guidelines using PPD tools
• Monitor and analyze project status and provide metrics to upper management
• Identify risks and develop contingency plans
• 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 standards
• Identify and evaluate issues affecting successful site activation
• Interpret complex data, make business decisions, and ensure solutions are implemented
• Develop customer relationships aligned with assigned projects

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification
• 5+ years of comparable previous experience
• Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered
• Ability to work effectively 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
• Comprehensive 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
• Comprehensive knowledge/understanding of clinical development guidelines and Directives
• Ability to use in-house and off-the-shelf computer software
• Ability to communicate and listen effectively
• Ability to perform under stress and multitask
• Regular and consistent attendance
• Ability to work in an upright and/or stationary position for 6–8 hours per day
• Ability to perform frequent mobility, occasional crouching and stooping, and frequent bending and twisting
• Ability to lift and carry 15–20 lbs
• Willingness and ability to travel up to 20% domestically and internationally
• Ability to work in office/laboratory and clinical environments, with potential exposure to biological fluids, infectious organisms, and electrical office equipment
• Ability to use required personal protective equipment, including protective eyewear, garments, and gloves

• Fully remote work mode
• Standard Monday–Friday work schedule
• Collaboration and development opportunities
• Global team environment
• Occasional travel opportunities to domestic and international site locations