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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, risk identification, and developing customer relationships within clinical research environments.
Highest-signal resume keywords
Clinical Research KnowledgeProject Management PrinciplesRisk Identification and Contingency PlanningCross-Functional Team LeadershipRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Site Activation ManagementProject Implementation PlanningFinancial ManagementContractual Deliverables ManagementMetrics Analysis
Soft Skills
Organizational SkillsMultitasking SkillsAttention to DetailCross-Cultural AwarenessCommunication Skills
Tools & Technologies
PPD ToolsComputer Software
Industry Keywords
Clinical Development GuidelinesMedical TerminologyTherapeutic AreasSite ContractsFeasibility Studies
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 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, completion, and metrics for upper management
- Identify risks and provide contingency planning
- Manage financial and contractual study aspects 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
Requirements
What you’ll need- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- 5+ years of previous comparable experience
- 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
- Comprehensive understanding of clinical research/development, medical and therapeutic areas, phases, and medical terminology
- Ability to lead, liaise, and coordinate cross-functional project teams
- Comprehensive knowledge/understanding of clinical development guidelines and Directives
- Ability to access and use in-house and off-the-shelf computer software
- Ability to communicate and understand spoken information
- Regular and consistent attendance
Benefits
Comp & perks- Global team environment
- Collaboration and development opportunities
- Scientific excellence-focused work environment