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Associate Start-up Team Manager
Thermo Fisher ScientificAssociate Site Activation Specialist managing site activation and regulatory submissions for Thermo Fisher Scientific clinical projects. Coordinating country-specific startup activities, compliance documentation, and internal teams.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in site activation strategies, regulatory compliance, and project management within the clinical research domain. Proficient in developing submission strategies and coordinating cross-functional teams to achieve project targets.
Highest-signal resume keywords
Site Activation ManagementRegulatory Compliance ExpertiseProject Target Cycle AchievementMentoring Junior StaffMedical Terminology Knowledge
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 ManagementRegulatory Guidelines KnowledgeSubmission Strategy DevelopmentTrial Status ManagementCritical Path Development
Soft Skills
Effective CommunicationInterpersonal SkillsAttention to DetailNegotiation SkillsOrganizational Skills
Tools & Technologies
Database Management SoftwareSubmission Activity Planning Tools
Certifications & Qualifications
Bachelor's Degree or Equivalent
Industry Keywords
Clinical ResearchSite ActivationSOPsEC RegulationsProcess Improvement
About the role
Key responsibilities & impact- Develop and manage the critical path for site activation within assigned projects
- Provide consultation, guidance, and support for rapid site activations
- Achieve established project target cycle times for site activations
- Act as country subject matter expert and provide local advice on activation strategy
- Develop and implement local submission strategy
- Provide technical expertise in collaboration with relevant internal departments
- Maintain knowledge of company and client SOPs/directives and current regulatory guidelines
- Prepare regulatory compliance review packages as applicable
- Liaise locally within the organization to plan and deliver submission activity according to global project strategy
- Develop country-specific documents
- Coordinate internal functional departments to align site startup activities with the activation critical path
- Maintain accurate and current trial status information in the database
- Participate in country process improvement initiatives
- Mentor junior staff or project support staff as appropriate
Requirements
What you’ll need- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 5+ years’, or equivalent combination of education, training, and experience
- Comprehensive English language and grammar skills
- Good computer skills and ability to learn appropriate software
- Good medical/therapeutic area and medical terminology knowledge
- Excellent knowledge of all applicable regional/national country regulatory guidelines and EC regulations
- Highly effective oral and written communication skills
- Excellent interpersonal skills
- Strong attention to detail and documentation quality
- Strong negotiation, judgment, decision-making, organizational, planning, multitasking, and teamwork skills
- Ability to work independently or in a team environment with minimal supervision
- Ability to mentor fellow team members
- Ability to retain a keen sense of urgency
Benefits
Comp & perks- Global team environment
- Collaboration and development opportunities
- Passion, innovation, and commitment to scientific excellence