Project Lead – Project Manager, FSP

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🕒 February 17

🐊 Florida, North Carolina – Remote

🐊 Florida – Remote 🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• The Project Manager serves as the Project Lead and primary sponsor contact and is accountable for the overall delivery of the project (quality, time, cost) on behalf of the organization. • Additionally, the Project Manager establishes and communicates customer expectations to the project team and ensures that escalation pathways are adhered to internally and externally. • The role involves leading the cross functional project team to meet or exceed deliverables. • Manages the day-to-day execution of assigned trials to ensure completion of established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. • Supports the Clinical Trial Lead in the development of specific study plans, development of core study documents, and systems set-up to ensure operational excellence in execution of the clinical trial protocol. • Develops required study specific training materials, including supporting the coordination of Investigator meetings. • Leads and chairs meetings with QSDO team members, including representatives from CTDU, CTAU and CSO to ensure the successful delivery of site activation and recruitment targets and evaluation recruitment strategies. • Provide accurate and up-to-date trial information in relevant tracking systems and provide regular updates of trial progress, issues, and risks to key SMT stakeholders during regularly scheduled meetings. • Depending on study needs, manage third-party study vendors including study specification creation, collection, and finalization in conjunction with the relevant functional SMEs. • Proactively identifies and resolves issues that arise during trial conduct, managing the escalation of trial-related issues. • Participates in and/or facilitates cross-functional collaboration and problem solving to ensure risk mitigation. • Supports the team to ensure timely data cleaning, data analysis and the availability of top line results. • Ensure project deliverables meet quality standards. • Ensures compliance with relevant sponsor policies and procedures. • Works with the Study Vendor Specialist to define project study specs during vendor setup. • Facilitate effective communication and collaboration among team members. • Adheres to project budgets, ensure timely billing and invoicing.

🎯 Requirements

• B.A. or B. Sc. in a scientific discipline. • 6 + years in clinical operations management, managing clinical trials per quality, timeline, and budget expectations, preferably with a Sponsor company and a CRO. • Related scientific and clinical expertise and exceptional project-management, risk-assessment, contingency-planning, and communication skills. • Extensive knowledge of clinical development related to one or more trial phases (I, II, III), as well as cross-functional drug development. • Expertise in Good Clinical Practices (GCP), International Council for Harmonization (ICH) guidelines and regulatory requirements for clinical development. • Ability to establish and execute operational plans. • Technical and systems competency, such as computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems. • Ability to delegate and effectively prioritize own and workload of project team members in a frequently changing environment

🏖️ Benefits

• Competitive salary • Flexible working hours • Professional development opportunities