FSP CTM at Thermo Fisher Scientific

Shanghai, Shanghai, China

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Pharmaceuticals, BiotechnologyIndustries

Requirements

Bachelor's degree or equivalent and relevant formal academic/vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
Good leadership skills

Responsibilities

Manages all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP
In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less sophisticated projects
Develops clinical tools (e.g. Supervising 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 the need arises
Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings
Collaborates with the clinical team and other departments as needed to meet deliverables of the project
Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained
Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies
Responsible for the timely archiving of documents and study materials for the department
Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and supervising clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing supervising visit reports, and managing CRF collection and query resolution
Continuously monitors or co-monitors clinical trials to assess performance and ensure contractual obligations are met
In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials
May connect with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues
May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed
Ensures that crucial document quality meets the expectation of Regulatory Compliance Review
Reviews and follows up on all questions raised by the ethics committees
May provide input into preparation of forecast estimates for clinical activities
Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements

Skills

Key technologies and capabilities for this role

ICH GCPClinical Trial ManagementTrial Master FileCRF DevelopmentMonitoring GuidelinesData Quality PlanMaster Action PlanBid DefenseClient Meetings

Questions & Answers

Common questions about this position

What is the work arrangement or location policy for this role?

This is a full-time position with a standard Monday-Friday work schedule in an office environment.

What are the key responsibilities of this FSP CTM role?

The role involves managing clinical operational and quality aspects of studies, developing clinical tools, ensuring Trial Master File quality, collaborating on project deliverables, and monitoring clinical trials to meet contractual obligations.

What skills or experience are required for this position?

Candidates need experience managing clinical trials of low to moderate complexity in compliance with ICH GCP, developing clinical tools like Supervising Plans and Monitoring Guidelines, and monitoring trial performance.

What is the company culture like at Thermo Fisher Scientific?

The company emphasizes meaningful work with global impact, enabling customers to make the world healthier, cleaner, and safer, while providing resources for career goals and advancing science through research and delivery of therapies.

What makes a strong candidate for this FSP CTM role?

Strong candidates will have determination to deliver quality and accuracy in clinical operations, experience with ICH GCP compliance, and the ability to manage study timelines, team communications, and monitoring processes effectively.

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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