Start-up Team Manager

🔥 2 minutes ago

🌐 United States, Canada – Remote

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🌲 North Carolina – Remote

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⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

Where this job comes from

Posted on Thermo Fisher Scientific's careers page, not through a job board

First seen by Remote Rocketship 2 minutes ago

Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Manage complex site operations and ensure compliance with regulatory standards • Support site recruitment and training efforts • Facilitate collaboration between trial sites and internal teams • Manage effective site activation within assigned regions • Oversee site activation according to timelines and quality standards • Coordinate SSU specialists across regions • Track sites against critical-path activation plans • Escalate regulatory and vendor setup issues • Facilitate knowledge transfer across countries within regions • Coordinate with Regional/Oversight Leads to resolve activation issues • Manage feasibility, site selection, contracts coordination, and EC/RA submissions • Oversee EC submission strategy, required documents, and quality checks for central and local ECs • Ensure operational readiness, including site binders, ancillary supplies, lab kits, training, and system access • Monitor regional study status, identify risks, and provide metrics to the SSU Oversight Lead • Maintain regional startup metrics and tracking tools • Perform risk identification, contingency planning, and risk escalation • Manage country and site Informed Consent Form timelines and approve country ICFs • Provide performance feedback and support staff learning opportunities • Prepare for and participate in country-level meetings • Manage clinical trial insurance local-policy setup • Oversee amendment implementation

🎯 Requirements

• Bachelor's Degree • 5+ years of previous experience providing the knowledge, skills, and abilities to perform the job • Study Start-Up (SSU) experience in CRO or Pharma organizations highly preferred • Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered • Effective collaboration with cross-functional teams • Knowledge of cross-functional project management principles • 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, 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 • Ability to perform frequent mobility, occasional crouching/stooping, bending and twisting • Ability to lift and carry objects up to 15–20 lbs • 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

• Fully remote work arrangement • Collaboration and development opportunities • Global team environment • Opportunity to contribute to scientific excellence and clinical-study breakthroughs

Apply Now

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