Experienced CTC FSP

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll 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 lifechanging 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.

Location/Division Specific Information

This homebased position requires candidates to reside in one of the following states:

Discover Impactful Work:

Provides administrative and technical support. Coordinates and facilitates project activities and may serve as a study lead acting as a crossfunctional liaison for the project team. Acts as a buddy during onboarding phase and provides training to new staff as needed. Supports departmental and crossfunctional initiatives for process improvements/enhancements.

A day in the Life:

• 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 including but not limited to: study team lists tracking of project specific training requirements system access management for organization/vendor/clients and tracking of project level activity plans in appropriate system. 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 but not limited to: timely processing of documents sent to Client (e)TMF as assigned performing (e)TMF reviews performing mass mailings and communications as needed providing documents and reports to internal team members.
• 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. Assists with clarification and resolution of findings related to site documentation.
• Maintains vendor trackers.
• Assists with coordination compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and nonclinical study supplies to sites.
• Assists with studyspecific translation materials and translation QC upon request.
• May attend Kick off meeting and take notes when required.

Keys to Success:

Education

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. Bachelors degree preferred.

Experience

Previous experience that provides the knowledge skills and abilities to perform the job (comparable to at least 4 years).

Knowledge Skills Abilities

• 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 decisionmaking skills

Physical Requirements / Work Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate receive and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.

Benefits

We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forwardthinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!

Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values Integrity Intensity Innovation and Involvement working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example this may include individuals requiring assistance because of hearing vision mobility or cognitive impairments. If you are a job seeker with a disability or assisting a person with a disability and require accessibility assistance or an accommodation to apply for one of our jobs please submit a request by telephone at*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

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