[Remote] Senior Clinical Trial Manager, FSP at Thermo Fisher Scientific

North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Clinical Research, BiotechnologyIndustries

Requirements

Interprets data on complex issues and makes good business decisions with support from line management
Works independently on projects of moderate to high complexity
May assume regional lead or Clinical Study Manager responsibilities
Compliance with ICH GCP

Responsibilities

Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP
In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; e.g. process improvements, manage complex programs, have wider management or project coordination responsibilities
Ensures efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set up (DM, Reg, CMC etc.): ensure feasibility reports are exhaustive, review site feasibility reports as per oversight plan, support the CPM in site selection, verify timely collection of essential study documents, such as regulatory and ethics committee documents for submission, and by controlling that all set up activities are performed prior to each site initiation, as per the oversight plan
Supports and ensures that all specific EDC system tasks under the clinical responsibility are completed and achieved according to the defined timelines without jeopardising the start of a trial
Supports the Clinical CRO in the training of the CRAs on all study specific operational activities and participates in the organisation and preparation of the monitor and investigator meetings in collaboration with the other study team members (Corporate and/or affiliates, CROs as appropriate)
Customizes site Key Risk/Performance Indicator template and follows these KRIs/KPIs at frequency agreed in the oversight plan
Validates the final clinical study documents (such as study manual, monitoring plan …) prepared by the Clinical CRO
Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan
Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents
Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central)
May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required
Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense meetings

Skills

Key technologies and capabilities for this role

ICH GCPClinical TrialsClinical OperationsStudy ManagementGCP ComplianceClinical DeliverablesProject ManagementQuality Management

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 key responsibilities of the Senior Clinical Trial Manager?

The role involves managing all clinical operational and quality aspects of allocated studies in compliance with ICH GCP, ensuring efficient study start-up by overseeing CRO clinical teams, supporting site selection and document collection, and handling EDC system tasks and CRA training.

What salary or compensation is offered for this position?

This information is not specified in the job description.

What is the company culture like at Thermo Fisher Scientific?

The company emphasizes meaningful work that positively impacts global health, provides resources for career goals, and supports advancing science through research, development, and delivery of life-changing therapies in clinical trials worldwide.

What makes a strong candidate for this Senior Clinical Trial Manager role?

Strong candidates have experience managing complex clinical studies independently, knowledge of ICH GCP compliance, skills in overseeing CRO teams for study start-up, site selection, regulatory documents, EDC systems, and CRA training.

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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