[Remote] Clinical Trial Manager (Sr.) - Cardiovascular and General Medicine at Thermo Fisher Scientific

Taiwan

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Deep knowledge and therapeutic expertise in Cardiovascular & General Medicine (e.g., Dermatology, GI (UC/CD), Cardiovascular, Liver, Nephrology, Immunology, Rare Disease, Diabetes, Obesity, Dyslipidemia, Women's Health, Rheumatology (RA, SLE, Gout), Cell & Gene Therapy, CAR-T in Autoimmune)
Ability to interpret data on complex issues and make good business decisions with support from line management
Experience working independently on projects of moderate to high complexity
Capability to assume regional lead or Clinical Study Manager responsibilities
Compliance with ICH GCP standards

Responsibilities

Lead all clinical operational and quality aspects of allocated studies of moderate to high complexity
Assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities, or additional roles such as process improvements, leading complex programs, or wider management/project coordination as per project requirements
Develop clinical tools (e.g., Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan
Contribute to the development of the Master Action Plan (MAP) for clinical-related documents
Ensure timely set up, organization, content, and quality of relevant sections of the Trial Master File (local and central)
Participate in the design and development of CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents
Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings
Collaborate with the clinical team and other departments to meet project deliverables
Regularly communicate with the team, lead team meetings to ensure timelines, resources, interactions, and quality are maintained
Implement and train on standardized clinical monitoring processes within the study according to corporate standard policies
Ensure timely archiving of documents and study materials for the department
Achieve the final clinical deliverable (e.g., clean data from evaluable patients) within the contractual time period by preparing and monitoring clinical activity timelines and metrics
Provide status updates to the project manager and regularly review projects using tracking tools
Work in partnership with the Project Manager to ensure training, tracking, and quality systems are in place for the clinical management team
Maintain profitability by ensuring clinical activity is conducted within contract scope through efficient management of the clinical team
Provide contact and support to the project sponsor for all clinical aspects

Skills

Clinical Trial Management

Project Management

Cardiovascular

General Medicine

Dermatology

Gastroenterology

Nephrology

Immunology

Rheumatology

Cell Therapy

Gene Therapy

CAR-T

Data Management

Quality Systems

Team Coordination

Budget Management

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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