[Remote] Trial Delivery Specialist - Clinical Trial Coordination at Thermo Fisher Scientific

Mexico

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, Clinical ResearchIndustries

Requirements

Ability to work closely with study managers and global study leaders
Expertise in trial coordination activities including data eTMF oversight, inspection readiness, vendor management, CRO oversight, and project planning
Strong partnership and teamwork skills across internal and external partners
Proficiency in monitoring study conduct, progress, risks, quality, timelines, and budgets
Experience with end-to-end operational study delivery from setup to archival
Capability to review key clinical documents (e.g., protocol, informed consent forms) and support development of study plans (e.g., monitoring, vendor management, protocol deviation, risk management plans)
Skills in coordinating study-related activities, cross-functional team communication, meeting preparation/scheduling, and facilitating interactions with regulatory, LOC, CROs, and vendors
Knowledge of country oversight activities including recruitment tracking, data completeness/compliance, local budgets, protocol deviations, and import licenses
Vendor management and CRO oversight expertise
Oversight of clinical supplies, investigational products (IP), and study materials
eTMF data oversight skills for inspection readiness (setup, reviews, missing documents, safety reports)
Handling of budget/financial activities including change orders, expenses, and system/agreement consistency

Responsibilities

Partner with global study leader to monitor study conduct/progress, identify/resolve/advance risks impacting quality, timeline, and budget
Collaborate on end-to-end study delivery activities, focusing on internal systems/databases/tracking tools and project plans
Review key clinical documents and support development of study plans (monitoring, vendor management, protocol deviation, risk management)
Coordinate study-related activities and cross-functional team communications, including meetings; facilitate interactions with internal/external partners (regulatory, LOC, CROs, vendors)
Support country oversight: act as primary contact, track recruitment, data completeness/compliance, local budgets, protocol deviations, import licenses
Manage vendor oversight and CRO oversight as primary contact, overseeing study-specific deliverables
Oversee delivery of clinical supplies, IP, and study materials; alert teams to issues/risks and recommend actions
Perform eTMF data oversight for inspection readiness: setup, periodic reviews, follow-up on missing documents, safety reports dissemination, ensure completeness/quality
Handle budget/financial activities: change orders, expenses, ensure system/agreement consistency, escalate issues

Skills

Key technologies and capabilities for this role

eTMFVendor ManagementCRO OversightProject PlanningStudy ManagementRisk ManagementProtocol ReviewInformed ConsentMonitoring PlansCross-Functional Team CoordinationClinical Trial Coordination

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 hours and office environmental conditions.

What are the key responsibilities of the Trial Delivery Specialist?

Key responsibilities include partnering with global study leaders to monitor study conduct, managing vendor and CRO oversight, ensuring eTMF completeness for inspection readiness, coordinating study activities and communications, and overseeing clinical supplies.

What skills or experience are needed for this role?

The role requires skills in clinical study management, data eTMF oversight, vendor and CRO management, project planning, risk management, and cross-functional team coordination across all phases and therapeutic areas.

What is the employment type for this position?

This is a full-time position.

What makes a strong candidate for the Trial Delivery Specialist role?

Strong candidates will have execution-focused experience in global clinical study delivery, including end-to-end operational activities, risk resolution, document review, and oversight of vendors, CROs, and eTMF systems.

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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