Mgr, Clinical Trials - Oncology

Remote

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Biotechnology, HealthcareIndustries

Requirements

A Bachelor's degree in life sciences or a related discipline is required, with an advanced degree preferred. Candidates must possess 8 years of clinical research experience, including at least 4 years in a leading role managing clinical trials. Experience supporting clinical trials in a regulated environment for 4-7 years is necessary, along with proficiency in MS Word, Excel, and PowerPoint. Strong analytical, organizational, planning, interpersonal, communication, and leadership skills are essential. The role also requires knowledge of Clinical Trial SOPs, FDA Regulations, and ICH-GCPs, along with the ability to work independently and collaboratively. Candidates must maintain current training in HIPAA/PHI privacy, Human Subjects Protection, GCP, and Natera's compliance and security policies, and pass a criminal background check.

Responsibilities

The Clinical Trial Manager will oversee all facets of clinical trials from initiation to completion, ensuring timelines, costs, and quality metrics are met in compliance with protocols and regulations. This includes selecting and managing vendors/CROs, handling study contracting, budgets, forecasting, and payments. Responsibilities also involve preparing study documents, training site personnel and vendors, developing monitoring plans, and managing data collection and reporting. The manager will lead study-related activities, train and mentor junior staff, monitor trial progress, and provide updates to stakeholders. Additionally, they will support prospective sample testing and collaborate with other departments to achieve project goals, while also developing SOPs and participating in audits.

Skills

Clinical Trial Management

Vendor Management

CRO Management

Budget Management

Forecasting

Contracting

Protocol Development

Informed Consent

Investigator Selection

Clinical Data Management

Regulatory Compliance

GCP

ICH

Natera

Genetic testing and diagnostics solutions provider

About Natera

Natera focuses on genetic testing and diagnostics, providing advanced solutions for cancer patients, transplant patients, and individuals assessing hereditary health risks. Their main technology is cell-free DNA (cfDNA) testing, which analyzes DNA fragments in the blood to detect minimal traces of cancer and assess organ health. Natera stands out by offering specialized tests like the Signatera ctDNA test and Panorama NIPT, along with genetic counseling services. The company's goal is to improve patient care and health outcomes through accurate genetic testing.

Austin, TexasHeadquarters

2004Year Founded

$149.9MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Flexible medical plans

Investment options

Time off

Workplace perks

Risks

Hindenburg report accuses Natera of deceptive sales practices, risking legal challenges.

New Prospera Heart features may face slow adoption by healthcare providers.

Fetal RhD NIPT demand may drop post-RhIg shortage, affecting future sales.

Differentiation

Natera's Signatera test offers personalized ctDNA analysis for cancer patients.

Prospera Heart test uses unique Donor Quantity Score for transplant rejection detection.

Panorama NIPT test is a leader in non-invasive prenatal testing with 2 million tests.

Upsides

Increased adoption of liquid biopsy techniques boosts demand for Natera's cfDNA tests.

AI integration enhances accuracy and speed of Natera's cfDNA analysis.

Growing personalized medicine trend aligns with Natera's customized genetic tests.

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