Senior Manager, Clinical Data Management at Arcellx

Redwood City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Minimum BA/BS in scientific or health-related field
Minimum of 7 years of clinical data management experience in the pharmaceutical, biotechnology industry or in a CRO
Oncology trial experience required, hematology/oncology preferred
Possesses a comprehensive understanding of regulatory guidelines and industry standards
Proficient with Medidata RAVE; experience working on Medidata Suite products preferred
Excellent communication skills, strong organizational skills, and ability to work independently and effectively prioritize tasks in a fast-paced setting

Responsibilities

Act as the lead data manager across one or more clinical studies
Provide expertise and oversight of all clinical database activities from design/start-up to closeout
Reviews protocols for appropriate data capture including electronic (eCRF) design
Support CRF design, review, and validation of clinical database
Provides oversight of database set-up/migrations/upgrades including coordinating and/or performing User Acceptance Testing
Conducts oversight of data management vendors via ongoing review of quality and performance metrics
Generates, resolves, and tracks data queries to ensure the integrity of the clinical data
Facilitates and participates in data cleaning activities
Generates and/or reviews/approves study documents
Responsible for maintaining internal data management timelines and metrics
Maintains study DM related documents/files for inspection readiness
Proactively identifies potential data management issues/risks and communicates it within the study team for further action

Skills

Key technologies and capabilities for this role

Clinical Data ManagementDatabase DesigneCRF DesignUser Acceptance TestingData ValidationData ManagementVendor Management

Questions & Answers

Common questions about this position

What experience level is required for this Senior Manager role?

A minimum of 7 years of clinical data management experience in the pharmaceutical, biotechnology industry or in a CRO is required, along with oncology trial experience (hematology/oncology preferred). A BA/BS in a scientific or health-related field is also required.

What specific technical skills are needed for this position?

Proficiency with Medidata RAVE is required, with experience working on Medidata Suite products preferred. Candidates need a comprehensive understanding of regulatory guidelines and industry standards.

Where are the company offices located, and is remote work mentioned?

The company offices are in Rockville, Maryland, and Redwood City, California. Remote work policy is not specified in the job description.

What is the company culture like at Arcellx?

Arcellx fosters a fun, diverse, supportive, and informal environment that is high-performing, inclusive, and collaborative. Core values include starting with authenticity, thinking ‘we’ before ‘me’, and embracing the challenge.

What makes a strong candidate for this role?

Strong candidates demonstrate values alignment with Arcellx's core values, bring diverse backgrounds and viewpoints, and have the required 7+ years of clinical data management experience in oncology trials with Medidata RAVE proficiency.

Arcellx

Develops immunotherapies for cell therapy

About Arcellx

Arcellx develops immunotherapies aimed at improving cell therapy for serious diseases. Their products focus on advanced techniques that enhance the effectiveness of treatments. The company collaborates with healthcare providers and research institutions to bring these therapies to patients. Unlike many competitors, Arcellx emphasizes proprietary products and partnerships to drive their research and development efforts. The goal is to meet unmet medical needs by providing safe and effective treatment options through their innovative approach to cell therapy.

Gaithersburg, MarylandHeadquarters

2014Year Founded

$194.5MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Unlimited Paid Time Off

Flexible Work Hours

401(k) Company Match

Fully-Paid Parental Leave

Tuition Reimbursement

Relocation Assistance

Risks

Competition from established CAR-T therapies like Abecma and Carvykti could limit market share.

Dependency on Gilead's Kite partnership poses risks if partnership dynamics change.

Phase 3 iMMagine-3 trial delays or failures could impact anito-cel's market timeline.

Differentiation

Arcellx's CART-ddBCMA has FDA Fast Track and Orphan Drug designations.

The novel D-Domain binder in anito-cel enhances antigen binding and cell killing.

ARC-SparX offers dosable and controllable CAR-T therapy options.

Upsides

Growing investment in personalized medicine aligns with Arcellx's tailored immunotherapies.

Advancements in gene editing like CRISPR enhance precision in engineered cell therapies.

Outpatient CAR-T administration could reduce costs and increase accessibility for Arcellx.

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