[Remote] Sr. Clinical Trial Coordinator at Thermo Fisher Scientific

Serbia

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Biotechnology, Clinical ResearchIndustries

Requirements

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job duties

Responsibilities

Provides administrative and technical support to the Project Team from start-up to closure phase
Supports audit readiness by ensuring files are reviewed on schedule detailed in the organization's WPD and department guidance document
Supports training of new staff and participates in departmental initiatives to support process improvements/enhancements
Coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix (according to Central or Local role)
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 risks to project leads and line manager
Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers (e.g., study team lists, tracking of project specific training requirements, system access management, tracking of project level activity plans)
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)
Supports RBM activities
Performs administrative tasks on assigned trials (e.g., timely processing of documents sent to Client (e)TMF, performing (e)TMF reviews, mass mailings and communications, providing documents and reports to internal team members)
Supports scheduling of client and/or internal meetings with completion of related meeting minutes
Reviews and tracks 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 non-clinical study supplies to sites
Assists with study-specific translation materials and translation QC upon request
May attend Kick off meeting and take notes when required

Skills

Key technologies and capabilities for this role

Clinical TrialsProject CoordinationAdministrative SupportAudit ReadinessTrial ManagementStaff TrainingProcess Improvement

Questions & Answers

Common questions about this position

What is the work schedule and location for this role?

This is a full-time position with a standard Monday-Friday schedule in an office environment.

What are the main responsibilities of a Sr. Clinical Trial Coordinator?

The role involves providing administrative and technical support to the Project Team, supporting audit readiness by reviewing files on schedule, and coordinating trial activities according to the task matrix for assigned trials.

What benefits does Thermo Fisher Scientific offer?

The company offers award-winning training and benefits focused on the health and wellbeing of employees, along with continued career advancement opportunities.

What is the company culture like at Thermo Fisher Scientific?

The culture emphasizes hiring the best, developing ourselves and each other, recognizing the power of being one team, and enabling impactful work in clinical research.

What skills or experience make a strong candidate for this position?

Strong candidates should have experience providing administrative and technical support in clinical trials, ensuring audit readiness and file reviews, and supporting process improvements or training new staff.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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