[Remote] Sr Clinical Trial Manager - FSP, France at Thermo Fisher Scientific

France

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Biotechnology, Clinical ResearchIndustries

Requirements

Experience coordinating clinical monitoring activities and overseeing CRO clinical/site management activities for international Phase 2/3 clinical studies
Knowledge of regulatory requirements, Good Clinical Practice (GCP) guidelines, and SOPs
Ability to ensure quality, timely delivery, and budget adherence in clinical studies
Capability to work within a matrix organization under Clinical Project Managers (CPM)
Skills in building relationships with investigators and acting as a client representative at sites
Experience with study start-up activities, including overseeing CRO clinical teams and collaborating with DM, reg, CMC, etc
Proficiency in reviewing site feasibility reports, supporting site selection, and verifying collection of essential study documents (e.g., regulatory and ethics committee documents)
Familiarity with Client/CRO EDC systems and ensuring timely completion of related tasks
Ability to support CRA training on study-specific operational activities
Experience in organizing and preparing monitor and investigator meetings in collaboration with study team members

Responsibilities

Coordinate clinical monitoring activities and oversee CRO clinical/site management for assigned international Phase 2/3 clinical studies
Ensure clinical activities coordination and oversight to achieve study deliverables
Oversee efficient and thorough study start-up, including review of site feasibility reports per oversight plan
Support CPM in site selection and verify timely collection of essential study documents prior to site initiation
Ensure all specific Client/CRO EDC system tasks under clinical responsibility are completed per timelines
Support Clinical CRO in training CRAs on study-specific operational activities
Participate in organization and preparation of monitor and investigator meetings with study team members
Assist CPM/study team in evaluating detailed timelines and establishing clinical study milestones
Build relationships with investigators as a client representative at sites
Deliver clinical excellence in accordance with regulatory requirements, GCP, and SOPs within budget

Skills

Key technologies and capabilities for this role

Clinical TrialsClinical MonitoringStudy ManagementCROFSPClinical Operations

Questions & Answers

Common questions about this position

What is the work location for this Sr Clinical Trial Manager role?

This information is not specified in the job description.

What is the salary or compensation for this position?

This information is not specified in the job description.

What are the key responsibilities of this role?

The role involves coordinating clinical monitoring activities, overseeing CRO clinical/site management for international Ph 2/3 studies, ensuring study start-up efficiency, reviewing site feasibility reports, and building relationships with investigators, all in accordance with GCP and SOPs.

What is the company culture like at Thermo Fisher Scientific's PPD division?

The culture emphasizes meaningful work with global impact, enabling customers to make the world healthier through high-quality clinical research, with a commitment to quality, timely delivery, and supporting career goals in a collaborative matrix organization.

What makes a strong candidate for this Sr Clinical Trial Manager position?

Strong candidates will have experience coordinating clinical monitoring and CRO oversight for international Phase 2/3 studies, knowledge of GCP guidelines and SOPs, and the ability to manage study deliverables in a matrix organization while building investigator relationships.

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.

Land your dream remote job 3x faster with AI

Try Jobo Free