[Remote] Local Study Associate at Thermo Fisher Scientific

Germany

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceutical, Clinical ResearchIndustries

Requirements

Compliance with international guidelines such as ICH-GCP and relevant local regulations
Ability to lead local study teams at country level
Capability to perform site monitoring as needed
Knowledge of Procedural Documents, SOPs, and local regulations
Skills in clinical and operational feasibility assessments
Experience in site selection, qualification visits, and quality risk assessments
Proficiency in coordinating EC/IRB submissions and Regulatory Authority applications
Competence in financial study management agreements (fSMA), study budgets, and clinical financial systems
Ability to prepare Master CSA, ICFs, and translations
Expertise in managing trial essential documents, drug activities, CTMS, and local websites
Skills in overseeing monitoring activities, reviewing visit reports, and performing co-monitoring/accompanied visits
Proactive risk identification, issue resolution, and risk management planning
Strong communication and coordination with teams, sites, investigators, and global stakeholders

Responsibilities

Lead Local Study Team(s) consisting of CRA(s), CSA(s) for assigned study/studies and optimize their performance ensuring compliance with Procedural Documents, ICH-GCP, and local regulations
Ensure overall responsibility for study commitments within the country and timely delivery of data to required quality
Perform clinical and operational feasibility assessments of potential studies to the highest quality, as required
Coordinate site selection process: identify potential sites/investigators, perform initial Site Quality Risk Assessment, and conduct Site Qualification Visits
Ensure timely submission of applications/documents to EC/IRB and coordinate with Regulatory Affairs for Regulatory Authority submissions throughout the study
Prepare country financial Study Management Agreement (fSMA), maintain accurate study budget via regular checks and financial reports
Prepare local Master CSA (including site budget) and amendments as needed
Prepare country level Master Informed Consent Form (MICF) and site level ICFs, including translations, per SOPs and regulations
Collect and verify all country and site level trial essential documents prior to site enrollment readiness
Plan and coordinate local drug activities (purchase/reimbursement to destruction)
Set up and maintain study in CTMS at country level and local websites as required by laws/regulations
Oversee, manage, and coordinate monitoring activities from site activation to closure per Monitoring Plans
Review monitoring visit reports, advise monitors, and perform co-monitoring/Accompanied Site Visits/training
Proactively identify risks, resolve complex study problems/issues, and develop/maintain/review country-level risk management plan
Organize regular agenda-driven Local Study Team meetings
Build good relationships with Local Study Team members, sites’ staff, and global stakeholders
Report study progress/updates to Global Study Associate Director/Global Study Team including SMM Lead
Contribute to patient recruitment strategy and communicate with Investigators
Manage sites, stakeholders, local/global vendors/customers to mitigate risks

Skills

Key technologies and capabilities for this role

ICH-GCPSite MonitoringSite QualificationCRA ManagementRegulatory SubmissionsEC/IRBStudy Budget ManagementClinical FeasibilitySite SelectionRisk Assessment

Questions & Answers

Common questions about this position

Is this a remote position or does it require office work?

This is an office-based role with standard Monday-Friday scheduling and environmental conditions listed as office. It is a fully client-embedded position dedicated to a leading bio-pharma company.

What are the key responsibilities of the Local Study Associate?

The role involves leading local study teams at country level to deliver clinical studies on time, within budget, and in compliance with ICH-GCP and local regulations, including site identification, qualification, monitoring, and documentation management. Additional duties include coordinating site selection, EC/IRB submissions, financial agreements, and monitoring activities.

What skills or experience are required for this position?

Experience leading local study teams, knowledge of ICH-GCP and local regulations, site monitoring, clinical feasibility assessments, regulatory submissions, and financial study management are essential.

What is the employment type and work schedule?

This is a full-time position with a standard Monday-Friday work schedule.

What makes a strong candidate for the Local Study Associate role?

Strong candidates will have proven leadership in managing local study teams, expertise in ICH-GCP compliance, site monitoring, regulatory submissions, and financial study budgeting to ensure timely delivery of high-quality clinical studies.

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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