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

Colombia

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 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 collaboration 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, managing cross-functional team communications, 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 and CRO oversight experience, including managing study-specific deliverables
Oversight of clinical supplies, investigational products (IP), and study materials from external providers
eTMF data oversight expertise (setup, reviews, missing documents, safety reports, quality verification)
Budget and financial management skills (change orders, expenses, system consistency)

Responsibilities

Partner with global study leaders to monitor study conduct and progress, identify, resolve, and escalate risks impacting quality, timeline, and budget
Collaborate on end-to-end operational study delivery, focusing on internal systems/databases/tracking tools and project plans
Review key clinical documents (protocol, informed consent) and support development of study plans (monitoring, vendor management, protocol deviation, risk management)
Coordinate study-related activities and manage cross-functional team communications, including meetings preparation/scheduling
Facilitate and monitor communications with internal/external team members (regulatory, LOC, CROs, vendors)
Support country oversight as primary contact, tracking 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, quality verification)
Manage budget/financial activities including change orders, expenses, system/agreement consistency, and issue escalation

Skills

eTMF

vendor management

CRO oversight

project planning

risk management

protocol review

study monitoring

clinical trial coordination

inspection readiness

study plans

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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