FSP Trial Delivery Specialist

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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

• Coordinate and facilitate project activities and may serve as a study lead • Perform department, Internal, Country and Investigator file reviews as assigned and document findings • Ensure allocated tasks are performed on time, within budget and to a high quality standard • Proactively communicate any risks to project leads and line manager • Support the maintenance of study specific documentation and global support with specific systems, tools and trackers • Ensure (e)TMF is up to date • Provide system support • Support RBM activities • Perform administrative tasks on assigned trials • Support scheduling and organization of client and/or internal meetings • Review and track local regulatory documents • Transmit documents to client and centralized IRB/IEC • Analyze and reconcile study metrics and findings reports • Maintain vendor trackers • Assist with coordination, compilation and distribution of Investigator Site File and Pharmacy binder materials • Assist with study-specific translation materials and translation QC upon request • Attend Kick off meeting and take notes when required

🎯 Requirements

• High / Secondary school diploma or equivalent • Bachelor's degree preferred • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years) • Ability to work in a team or independently as required • Strong organizational skills and attention to detail • Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency • Strong customer focus • Demonstrated flexibility and adaptability to reprioritize workload • Demonstrated ability to maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for clinical aspects of project implementation • Excellent English language and grammar skills • Good presentation skills • Excellent computer skills, proficient in MS Office and ability to master clinical trial database systems • Ability to successfully complete PPD clinical training program • Self-motivated, positive attitude with effective strong interpersonal skills

🏖️ Benefits

• Health insurance • Retirement plans • Flexible work arrangements • Professional development opportunities