Project Manager

🕒 August 7

🐎 Kentucky – Remote

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⏰ Full Time

🟢 Junior

🟡 Mid-level

👷‍♀️ Project Manager

🦅 H1B Visa Sponsor

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

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

• Lead and coordinate central laboratory activities across clinical trial programs • Monitor and manage designated clinical trial protocols in Global Central Labs • Ensure overall project performance and client satisfaction throughout assigned trial lifecycles • Provide internal consulting on project management issues and identify process and efficiency improvements • Act as chief liaison to sponsors, operational personnel, internal departments, external vendors, and stakeholders • Oversee and coordinate study initiation • Review, interpret, translate, and program study protocols into complete and accurate databases • Facilitate technical and clinical laboratory information flow to stakeholders • Prepare study specification documents according to budgets and contracts • Maintain updated study master files with version controls • Ensure sponsor authorization, document sign-off, and contract completion before service delivery • Assure compliance with FDA, Good Clinical Practice, PPD SOPs, IATA, and biological-specimen transport regulations • Coordinate protocol amendment reviews and obtain cross-functional commitment to resolve gaps and issues • Educate investigator sites through protocol-specific laboratory procedure presentations and demonstrations • Manage day-to-day clinical trial activities, resolve issues, and answer queries • Consult with IT and data management groups on software and functionality design, validation, and implementation • Support RFP feasibility assessments and draft proposal responses • Guide, train, and mentor Project Managers and Set-up Administrators • Author, review, revise, and implement procedural documents • Serve as backup for the Associate Director PM when needed

🎯 Requirements

• Bachelor’s degree or equivalent and relevant formal academic/vocational qualification • Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 2+ years, or equivalent combination of education, training, and experience • Strong verbal, written, and presentation skills • Superior time management, planning, and organizational skills • Competence with computers and enterprise applications, including office productivity applications • Ability to program the IT system according to protocol requirements • Proven analytical skills • Demonstrated compliance with procedures and policies • Ability to perform multiple tasks effectively in a stressful environment • Extensive knowledge and experience in project management in a Global Central Lab environment • Strong client relationship management skills • Ability to work effectively with multi-level teams • Ability to communicate, receive, and understand information and ideas with diverse groups • Ability to work upright and stationary for typical working hours • Ability to use and learn standard office equipment and technology proficiently • Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities • May require travel • Must be legally authorized to work in the United States without sponsorship • Must pass a comprehensive background check, including drug screening

🏖️ Benefits

• Fully remote work arrangement • Opportunity to collaborate with industry-leading experts • Contribution to groundbreaking clinical research • Career growth within an environment valuing innovation, accountability, and continuous development • Reasonable accommodation for applicants with disabilities • Equal employment opportunity and accessibility support

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