[Remote] Sr. Clinical Team Manager - Nephrology/CVGM at Thermo Fisher Scientific

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

Clinical Research, Pharmaceuticals, HealthcareIndustries

Requirements

Therapeutic expertise in Nephrology (CKD, IgAN, Kidney transplant, and/or Lupus Nephritis required); other areas as asset: Dermatology, GI (UC/CD), Cardiovascular, Liver, Immunology, Rare Disease, Diabetes, Obesity, Dyslipidemia, Women's Health, Rheumatology (RA, SLE, Gout), Cell & Gene Therapy, CAR-T in Autoimmune
Deep knowledge and ability to interpret data on complex issues and make business decisions with support from line management
Experience working independently on projects of moderate to high complexity, potentially assuming regional lead or Clinical Study Manager responsibilities
Compliance with ICH GCP standards

Responsibilities

Manage 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, managing complex programs, or wider 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 as required
Collaborate with the Project Manager to prepare, organize, and present at client meetings
Coordinate activities of Clinical Management members allocated to projects on a Regional or Country basis
Work in partnership with the Project Manager to ensure training, tracking, and quality systems are in place for the clinical management team
Be primarily responsible for clinical deliverables within agreed timelines and budget
Provide contact and support to the project sponsor for all clinical aspects
Achieve final clinical deliverable (clean data from evaluable patients as specified in the study protocol) within contract timelines
Ensure all clinical deliverables meet customer time/quality/cost expectations
Maintain profitability by managing clinical activity within contract scope through efficient team management

Skills

Clinical Trial Management

Nephrology

CKD

IgAN

Kidney Transplant

Lupus Nephritis

Cardiovascular

Project Management

Clinical Deliverables

Therapeutic Expertise

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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