Project Support Coordinator / TMF Support Coordinator with English at Thermo Fisher Scientific

Sofia, Sofia City Province, Bulgaria

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Clinical Research, PharmaceuticalsIndustries

Requirements

Bachelor's degree/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 (comparable to 0 to 1 year)
Excellent command of English – verbal and written
Working Knowledge of computer systems including Microsoft Word, Excel, Outlook and PowerPoint (or equivalent)
Ability to work in a team or independently as required
Good organizational and time management skills as well as strong attention to detail with proven track record to handle multiple tasks efficiently and effectively
Flexibility and adaptability to provide efficient support while meeting tight project timelines
Strong customer focus and good interpersonal skills
Effective oral and written communication skills

Responsibilities

Provides administrative and technical support to project teams by filing documents in PPD’s eTMF and/or client eTMFs
Liaises with project and functional leads, clinical operations staff, and other relevant team members to facilitate document collection and retention
Reviews study-related or essential documents for completeness and compliance with protocol and relevant regulations
Tracks and/or pushes down documents in CTMS (as required) and manages electronic eTMF study documents
Performs quality checks, files documents in PPD’s eTMF at study, country, and site levels and promotes documents to a status of “Approved”
Classifies and indexes eTMF documentation with accurate attributes and metadata according to department standards
Identifies and records quality issues, communicating with colleagues globally regarding errors in documents, providing solutions and resolving issues, as appropriate
Compiles and distributes eTMF metrics reports to Project Leads and team members for assigned studies and follows up on issues noted
Provides systems (e.g., CTMS, SharePoint & eTMF) support by managing access requests within the centralized filing support team
Files documents in client eTMFs as specified by a study’s eTMF plan

Skills

Key technologies and capabilities for this role

eTMFTMFfiling documentsdata collectionreport preparationaudit readinessSOPsaccess requestsproject documentationEnglish

Questions & Answers

Common questions about this position

What work arrangements are available for this role?

Office, Flex and Remote work options are available. Remote employees based in Sofia will be expected to visit the office regularly (around 2-3 times a week) for a period of 3 to 6 months to ensure successful onboarding and adaptation.

What is the salary or compensation for this position?

This information is not specified in the job description.

What skills are required for the Project Support Coordinator role?

The role requires skills in providing administrative and technical support, filing and managing documents in eTMF systems, performing quality checks and compliance reviews, tracking documents in CTMS, and communicating globally to resolve issues.

What is the company culture like for this team?

The team is described as friendly and focused on making new employees feel truly welcome and supported, with an emphasis on collaboration across project leads, clinical operations staff, and global colleagues.

What makes a strong candidate for this TMF Support Coordinator position?

Strong candidates will have experience in clinical trial documentation, eTMF and CTMS systems, attention to detail for quality checks and compliance, and the ability to liaise effectively with global teams.

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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