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Start-up Manager, FSP
Thermo Fisher Scientific. Manage complex site operations and ensure compliance with regulatory standards .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing complex site operations, ensuring compliance with regulatory standards, and facilitating collaboration among cross-functional teams. Proficient in project management principles, clinical research, and developing customer relationships aligned with project goals.
Highest-signal resume keywords
Site Operations ManagementCross-Functional Project ManagementClinical Research KnowledgeRisk Identification and Contingency PlanningBudget Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Project Implementation PlanningSite Activation OversightRegulatory ComplianceContractual ManagementMetrics Analysis
Soft Skills
Organizational SkillsAttention to DetailCross-Cultural AwarenessCommunication SkillsMultitasking Ability
Tools & Technologies
PPD ToolsComputer Software
Certifications & Qualifications
Bachelor's Degree or Equivalent
Industry Keywords
Clinical Development GuidelinesMedical TerminologyStudy PhasesFeasibility StudiesSite Contracts
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Global team environment
- Collaboration and development opportunities
- Scientific excellence-focused workplace