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.
PV Coordinator, Senior PV Coordinator
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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
• Coordinate timely review of protocol inquiries, serious and non-serious adverse events, diagnostics, and Data Safety Monitoring Board data • Track necessary data and generate reports for clients, project teams, and external vendors • Represent the DSMB/EAC Coordination Team at global and domestic committee meetings via teleconference and face-to-face meetings • Coordinate meeting logistics and assist with facilitation • Liaise with internal and external parties to implement projects • Prepare and coordinate approval of Confidentiality Disclosure Agreements, Letters of Intent, and Member Agreements • Compile adjudication dossiers and submit follow-up to investigative sites • Coordinate and facilitate project meetings, draft minutes, and distribute meeting materials • Post blinded and unblinded minutes/materials to client portals • Manage project-specific training and program file setup, maintenance, and archival • Identify and redact subject identifiers, retrain sites, and escalate recurring issues to Data Privacy • Perform data entry and system reconciliations to identify issues affecting project timelines • Oversee expenses and manage translations within budget parameters • Support specific activities performed by the local office that cannot be performed elsewhere • Provide training to junior staff
🎯 Requirements
• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Technical positions may require a certificate • At least 2 years of previous relevant experience, comparable to the knowledge, skills, and abilities required for the role • Combination of appropriate education, training, and/or directly related experience may be considered sufficient as an equivalency • Strong problem-solving skills • Ability to work independently with minimal supervision • Ability to build strong relationships • Ability to analyze project-specific data and systems for accuracy and efficiency • Ability to communicate respectfully and diplomatically with clients, management, project team members, and internal staff • Effective oral and written communication and interpersonal skills • Excellent computer skills, including MS Office (Word, Excel, PowerPoint, Access) • Ability to prioritize and perform multiple tasks simultaneously under strict deadlines • Strong attention to detail and accuracy • Ability to maintain a positive and professional demeanor in challenging circumstances • Flexibility to reprioritize workload as project timelines change • Working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and organizational/client SOPs and WPDs for non-clinical and clinical project implementation, execution, and closeout
🏖️ Benefits
• Fully remote work arrangement • Standard Monday–Friday work schedule • Training and development opportunities, including providing training to junior staff • Potential benefits and privileges of employment • Reasonable accommodation for individuals with disabilities • Equal employment opportunity and non-discrimination
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