Full-Time

Senior Manager

Clinical Data Management

Confirmed live in the last 24 hours

Arcellx

Arcellx

51-200 employees

Develops immunotherapies for cell therapy

Compensation Overview

$180k - $195k/yr

+ Bonus + Equity Grant

Senior, Expert

San Carlos, CA, USA

In Person

Relocation assistance is offered for roles if required.

Category
Data Management
Data & Analytics
Required Skills
Data Analysis
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.
  • Familiarity with various data visualization, analytics, and reporting tools is a plus.
  • 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.
Desired Qualifications
  • Familiarity with various data visualization, analytics, and reporting tools is a plus.

Arcellx develops immunotherapies aimed at transforming cell therapy for serious diseases. The company focuses on creating proprietary products that utilize advanced cell therapy techniques. Their approach involves extensive research and development, leading to the commercialization of these therapies once they receive regulatory approval. Arcellx primarily serves healthcare providers, research institutions, and patients seeking effective treatments. Unlike many competitors, Arcellx emphasizes addressing unmet medical needs through its specialized knowledge in cell therapy. The company's goal is to provide safe and effective treatment options for patients suffering from serious conditions.

Company Size

51-200

Company Stage

IPO

Headquarters

Gaithersburg, Maryland

Founded

2014

Simplify Jobs

Simplify's Take

What believers are saying

  • Partnership with Kite enhances Arcellx's multiple myeloma program development.
  • Recent clinical data shows robust long-term responses for CART-ddBCMA.
  • Advancements in gene editing could improve Arcellx's CAR-T product efficacy.

What critics are saying

  • Competition from Legend Biotech and Johnson & Johnson's Carvykti is significant.
  • High costs of CAR-T therapies may limit market adoption and accessibility.
  • Dependence on partnerships like Kite could pose strategic risks.

What makes Arcellx unique

  • Arcellx's CART-ddBCMA has Fast Track and Orphan Drug designations from the FDA.
  • The ARC-SparX platform offers dosable and controllable CAR-T therapy options.
  • Anito-cel uses a novel D-Domain BCMA binder for enhanced multiple myeloma cell targeting.

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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

Growth & Insights and Company News

Headcount

6 month growth

-3%

1 year growth

1%

2 year growth

-3%
Business Wire
May 21st, 2025
Arcellx Announces Its Participation at TD Cowen's 6th Annual Oncology Innovation Summit and Its Investor Event During EHA2025

Arcellx announces its participation at TD Cowen's 6th Annual Oncology Innovation Summit and its investor event During EHA2025.

Business Wire
Mar 20th, 2025
Arcellx Appoints Andrew Galligan and Kristin Myers to Its Board of Directors

Arcellx appoints Andrew Galligan and Kristin Myers to its Board of Directors.

BioSpace
Feb 28th, 2025
Arcellx To Participate At The Td Cowen 45Th Annual Health Care Conference

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today announced that management will participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference on Wednesday, March 5, at 1:10 p.m. ET.A live webcast of this discussion will be accessible from Arcellx’s website at www.arcellx.com in the Investors section. A replay of the webcast will be archived and available for 30 days following the event.About Arcellx, Inc.Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. Arcellx believes that cell therapies are one of the forward pillars of medicine and Arcellx’s mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible

Business Wire
May 9th, 2024
Arcellx And Kite Continue Momentum With Advances In Anito-Cel Multiple Myeloma Program

REDWOOD CITY, Calif. SANTA MONICA, Calif.--(BUSINESS WIRE)--Arcellx, Inc. (NASDAQ: ACLX) and Kite, a Gilead Company (NASDAQ: GILD), today announced several key operational updates on their partnered anitocabtagene autoleucel (anito-cel) multiple myeloma program. Anito-cel is the first BCMA CAR T to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact D-Domain binder. The companies shared the design of a global, Phase 3 randomized controlled clinical trial, iMMagine-3, which Kite expects to start in the second half of this year. The trial will compare the efficacy and safety of anito-cel randomized against the standard of care (SOC) in patients with relapsed and/or refractory multiple myeloma (rrMM) who have received one to three prior lines of therapy, including an immunomodulatory drug (lMiD) and an anti-CD38 monoclonal antibody

Business Wire
May 9th, 2024
Kite And Arcellx Continue Momentum With Advances In Anito-Cel Multiple Myeloma Program

REDWOOD CITY, Calif. SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite, a Gilead Company (NASDAQ: GILD), and Arcellx, Inc. (NASDAQ: ACLX) today announced several key operational updates on their partnered anitocabtagene autoleucel (anito-cel) multiple myeloma program. Anito-cel is the first BCMA CAR T to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact D-Domain binder. The companies shared the design of a global, Phase 3 randomized controlled clinical trial, iMMagine-3, which Kite expects to start in the second half of this year. The trial will compare the efficacy and safety of anito-cel randomized against the standard of care (SOC) in patients with relapsed and/or refractory multiple myeloma (rrMM) who have received one to three prior lines of therapy, including an immunomodulatory drug (lMiD) and an anti-CD38 monoclonal antibody