Senior Clinical Team Manager (Prin.) - HemOnc

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, HealthcareIndustries

Requirements

Candidates should possess deep knowledge and therapeutic expertise in areas such as Ovarian, Sickle Cell, Non-Hodgkins Lymphoma, Multiple Myeloma, Glioma, Head and Neck, Pancreas, Prostate, Non-Small Cell Lung, Breast, Colorectal, Radiopharmaceutical, Cell and Gene Therapy, and CART-T. The role requires the ability to work independently on projects of moderate to high complexity and potentially assume regional lead or Clinical Study Manager responsibilities. Compliance with ICH GCP is essential.

Responsibilities

The Senior/Principal Clinical Team Manager will lead all clinical operational and quality aspects of allocated studies, ensuring compliance with ICH GCP. This includes developing clinical tools, contributing to the Master Action Plan, and ensuring the timely setup and quality of the Trial Master File. The role involves collaborating with project managers and other departments to meet project deliverables, communicating regularly with the team, leading team meetings, and implementing standardized clinical monitoring processes and training.

Skills

Clinical Trial Management

Project Management

Clinical Deliverables

Therapeutic Expertise

Ovarian Cancer

Sickle Cell Disease

Non-Hodgkins Lymphoma

Multiple Myeloma

Glioma

Head and Neck Cancer

Pancreatic Cancer

Prostate Cancer

Non-Small Cell Lung Cancer

Breast Cancer

Colorectal Cancer

Radiopharmaceutical

Cell and Gene Therapy

CART-T

Data Management

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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