[Hiring] Start-up Team Manager @Thermo Fisher Scientific

Role Description

As the Start-up Team Manager (FSP) at Thermo Fisher Scientific, you will play a pivotal role in site activation & manage complex site operations; ensure compliance with regulatory standards. In addition, this individual will be responsible for:

• Supporting site recruitment and training efforts.
• Facilitating smooth collaboration between trial sites and internal teams to drive the success of clinical studies.
• Managing effective delivery of site activation within assigned region(s).
• Overseeing site activation according to timelines and quality standards.
• Coordinating with others on a cross-functional level.
• Managing technical and operational aspects.

Key Responsibilities:

• Collaborate with team members to ensure effective site activation within assigned studies.
• Coordinate SSU specialists across regions.
• Ensure sites within their specific region are on track with the critical path site activation plan.
• Serve as an escalation point for issues identified by SSU specialists, including regulatory and vendor setup issues.
• Facilitate knowledge transfer across countries within regions.
• Work with other Regional/Oversight Leads to resolve issues and ensure activation activities adhere to the agreed plan.
• Oversee EC submission strategy and required documents (e.g., patient material, insurance certificates).
• Provide quality checks for EC submission packages for both central and local ECs.
• Manage technical and operational aspects, including feasibility, site selection, contracts coordination, and EC/RA submissions.
• Ensure operational readiness for site activation in collaboration with CML (e.g., site binders, ancillary supplies, lab kits, training, system access).
• Monitor regional study status, identify risks, and provide metrics to Study Start-up (SSU) Oversight Lead.
• Maintain metrics and tracking tools for regional startup activity.
• Perform risk identification and contingency planning, participate in risk escalation meetings as required, and collaborate with study team to address issues and implement solutions for countries and sites in region.
• Manage country and site Informed Consent Form (ICF) timelines; review and approve country ICFs.
• Provide performance feedback to People Manager and support staff learning opportunities.
• Utilize problem-solving techniques in a changing environment.
• Prepare for and participate in country level meetings.
• Oversee and manage the clinical trial insurance local policy country set-up for region.
• Oversee and manage amendment implementation as needed.

Qualifications

• Bachelor's Degree.
• Must have previous experience that provides the knowledge, skills, and abilities to perform the job comparable to 5+ years.
• SSU experience has been in: CRO, Pharma organizations, highly preferred.
• In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Requirements

• Effective collaboration with cross-functional teams.
• Knowledge of key principles of cross-functional project management.
• Strong organizational and multitasking skills.
• Attention to detail.
• Ability to identify and mitigate risks related to contractual deliverables.
• Cross-cultural awareness and adaptability.
• Comprehensive understanding of clinical research and development, including medical and therapeutic areas, phases, and terminology.
• Ability to lead, liaise, and coordinate cross-functional project teams.
• Knowledge of clinical development guidelines and directives.

Benefits

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthrough.