Project Lead/Project Manager - FSP

Thermo Fisher Scientific is a global team that values passion and innovation, and they are seeking a Project Lead/Project Manager to oversee the delivery of clinical projects. The role involves managing day-to-day execution of clinical trials, ensuring compliance with regulatory requirements, and leading cross-functional teams to meet project goals.

Responsibilities:

• 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. Refer Study Vendor Specialist Job Description
• 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
• Effective oral and written communication and presentation skills
• Proactive, solutions oriented and adaptable to changing priorities and situations
• An advanced degree in a related field
• Investigator site and/or monitoring experience
• Functional Service Provider (FSP) experience