Thermo Fisher Scientific · 1 week ago
Start Up Team Manager, FSP
United States
Full-time
Remote
Senior Level
5+ years expThermo Fisher Scientific is a global leader in scientific excellence, and they are seeking a Start Up Team Manager to oversee site activation and manage complex site operations. This role involves ensuring compliance with regulatory standards, supporting recruitment and training efforts, and facilitating collaboration between trial sites and internal teams to drive the success of clinical studies.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
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 site activation according to timelines and quality standards within their specific region
Assist with information flow between key stakeholders involved in site activation
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
Qualification
Required
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
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
Ability to work in an upright and /or stationary position for 6-8 hours per day
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
Frequent mobility required
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs
Ability to access and use a variety of computer software developed both in-house and off-the-shelf
Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences
Frequently interacts with others to obtain or relate information to diverse groups
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
Ability to perform under stress
Ability to multi-task
Regular and consistent attendance
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Daniella Cramp
Senior Vice President and President, Bioproduction Group
Recent News
Genetic Engineering News
2026-01-16
Company data provided by crunchbase