Clinical Team Manager (Sr.)-Cardiovascular and General Medicine-Nephrology

North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Candidates should have a strong understanding of clinical trial management and therapeutic expertise in Cardiovascular & General Medicine-Nephrology. The role requires the ability to coordinate clinical management activities on a regional or country basis, work in partnership with Project Managers, and ensure necessary training, tracking, and quality systems are in place. Experience in developing clinical tools such as Monitoring Plans and Monitoring Guidelines is expected, along with participation in the design and development of CRFs and other protocol-specific documents.

Responsibilities

The Clinical Team Manager is accountable for achieving final clinical deliverables within contracted timelines and budget, ensuring all clinical activities are conducted within contract scope and maintaining project profitability. They will manage all clinical operational and quality aspects of allocated studies in compliance with ICH GCP, potentially assuming Lead CTM or Clinical Study Manager responsibilities. Responsibilities include developing clinical tools, contributing to the Master Action Plan, ensuring the timely setup and quality of the Trial Master File, and collaborating with project managers and clinical teams to prepare for and present at client meetings.

Skills

Clinical Trial Management

Project Management

Therapeutic Expertise

Nephrology

Cardiovascular Medicine

General Medicine

CKD

Delayed Graft Function

Antibody-Mediated Rejection

IgA Nephropathy

Lupus Nephritis

Training

Quality Systems

Budget Management

Timeline 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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