Experienced CTC (FSP)

Thermo Fisher Scientific

287d • Remote

About The Position

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
• 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.
• Flexibility to reprioritize workload to meet changing project timelines.
• Demonstrated ability to attain and maintain a solid understanding of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.
• Good English language and grammar skills and proficient local language skills as needed.
• Good digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems.
• Effective oral and written communication skills.
• Crucial judgment and decision-making skills.

Responsibilities

• Provides administrative and technical support.
• Coordinates and facilitates project activities and may serve as a study lead acting as a cross-functional liaison for the project team.
• Acts as a buddy during onboarding phase and provides training to new staff as needed.
• Supports departmental and cross-functional initiatives for process improvements/enhancements.
• Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.
• Ensures allocated tasks are performed on time, within budget and to a high quality standard.
• Proactively communicates any risks to project leads and line manager as appropriate.
• Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers.
• Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system.
• Provides system support (i.e. GoBalto & eTMF).
• Performs administrative tasks on assigned trials including timely processing of documents sent to Client (e)TMF.
• Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
• Reviews and supervises local regulatory documents.
• Transmits documents to client and centralized IRB/IEC.
• Analyzes and reconciles study metrics and findings reports.
• Maintains vendor trackers.
• Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials.
• Assists with study-specific translation materials and translation QC upon request.
• May attend Kick off meeting and take notes when required.

Benefits

• Competitive remuneration.
• Annual incentive plan bonus.
• Healthcare.
• Range of employee benefits.
• Outstanding career and development prospects.
• Exciting company culture that stands for integrity, intensity, involvement, and innovation.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: High school or GED