Start-up Manager, FSP
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Job Description
Start-up Manager overseeing clinical-trial site activation, contracts, feasibility, and compliance for Thermo Fisher Scientific. Managing cross-functional teams, project risks, budgets, and timelines remotely from Mexico.
Responsibilities:
- Manage complex site operations and ensure compliance with regulatory standards
- Support site recruitment and training efforts
- Facilitate collaboration between trial sites and internal teams
- Collaborate with matrixed team members to deliver site activation for 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, completion, and metrics for 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-team coordination
- Manage assigned scope of work against timelines, costs, and quality
- Identify and evaluate fundamental site activation issues and implement solutions
- Develop customer relationships aligned with assigned projects
Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience comparable to 5+ years
- 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
- Comprehensive understanding of clinical research/development, medical and therapeutic areas, study phases, and medical terminology
- Ability to lead, liaise, and coordinate cross-functional project teams
- Comprehensive knowledge of clinical development guidelines and Directives
- Ability to work in an office/laboratory and/or clinical environment
- Ability to use in-house and off-the-shelf computer software
- Ability to communicate and understand spoken and written information
- Regular and consistent attendance
- Occasional travel up to 20% of the time, including domestic and international site travel
Benefits:
- Global team environment
- Collaboration and development opportunities
- Scientific excellence-focused workplace
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