FSP Sr CTM at Thermo Fisher Scientific

Beijing, Beijing, China

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Clinical Research, Life Sciences, PharmaceuticalsIndustries

Requirements

Interprets data on sophisticated 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
Knowledge of clinical tools development (e.g., Supervising Plan, Monitoring Guidelines)
Ability to develop clinical related documents and contribute to Master Action Plan (MAP)
Experience with Trial Master File (TMF) setup, organization, content, and quality
Participation in design and development of CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents
Ability to collaborate with project managers for client meetings, bid defenses, and hand-off meetings
Experience in clinical monitoring processes, training, and standardization
Proficiency in preparing and supervising clinical activity timelines and metrics
Use of tracking and management tools for project reviews and recovery actions
Conducting Accompanied Field Visits (AFVs)
Accountability for project financials
Communication with study sites on protocol, patient participation, CRF completion, and study-related issues
Coordination responsibilities (incomplete in description)

Responsibilities

Manages all clinical operational and quality aspects of allocated studies of moderate to high complexity
Assumes Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities, or additional roles (e.g., process improvements, sophisticated programs, wider management, project coordination)
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 clinical related documents
Ensures timely set up, organization, content, and quality of relevant sections of the Trial Master File (local and central)
Participates in design and development of CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents
Collaborates with project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings
Collaborates with clinical team and other departments to meet project deliverables
Regularly communicates with team, leads team meetings to ensure timelines, resources, interactions, and quality are maintained
Implements and trains on standardized clinical monitoring processes within the study and according to corporate policies
Responsible for timely archiving of documents and study materials
Ensures achievement of final clinical deliverable within contractual time by preparing/supervising timelines/metrics, providing status updates, reviewing projects with tools, implementing recovery actions, reviewing supervising visit reports, managing CRF collection/query resolution
Continuously supervises clinical trials to assess performance and ensure contractual obligations
Routinely conducts Accompanied Field Visits (AFVs)
Accountable for project financials to maintain profitability within contract scope
Communicates with study sites on issues such as protocol, patient participation, CRF completion, and other study-related issues
May coordinate (incomplete in description)

Skills

Key technologies and capabilities for this role

ICH GCPClinical Trial ManagementGCP ComplianceClinical OperationsStudy ManagementProcess ImprovementTeam ManagementQuality Management

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 position?

The role involves managing all clinical operational and quality aspects of allocated studies of moderate to high complexity in compliance with ICH GCP, developing clinical tools, contributing to project plans, and collaborating with teams to meet deliverables.

What salary or compensation is offered for this role?

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 focuses on research, development, and delivery of life-changing therapies through collaborative clinical research.

What makes a strong candidate for this Sr CTM position?

Strong candidates have experience managing clinical studies of moderate to high complexity independently, expertise in ICH GCP compliance, and the ability to interpret sophisticated data, make business decisions, and lead regional or additional responsibilities.

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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