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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 overseeing site activation processes. Proficient in cross-functional project management, risk identification, and developing customer relationships within clinical research environments.
Highest-signal resume keywords
Clinical Research KnowledgeCross-Functional Project ManagementRisk Identification and Contingency PlanningSite Activation ManagementRegulatory 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
Project Implementation PlanningData InterpretationFinancial ManagementContractual ManagementMetrics AnalysisSite Contract AdministrationFeasibility AssessmentClinical Development GuidelinesMultitaskingAttention to Detail
Soft Skills
CollaborationOrganizational SkillsCross-Cultural AwarenessCommunication SkillsAdaptability
Tools & Technologies
PPD ToolsComputer Software
Certifications & Qualifications
Bachelor's Degree or Equivalent
Industry Keywords
Clinical ResearchMedical TerminologyStudy PhasesTherapeutic AreasRegulatory Standards
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 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 recommended 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 against timelines, costs, and quality
- 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
Requirements
What you’ll need- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- 5+ years of comparable previous experience
- Equivalency may consist of appropriate education, training and/or directly related experience
- 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 with, and coordinate cross-functional project teams
- Comprehensive knowledge of clinical development guidelines and Directives
- Ability to use in-house and off-the-shelf computer software
- Ability to communicate and understand spoken information
- 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 lift and carry 15–20 lbs.
- Occasional travel up to 20% domestically and internationally
Benefits
Comp & perks- Global team environment
- Collaboration and development opportunities
- Scientific excellence-focused work environment