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Senior Manager, Clinical Data Management

ArcellxOnsite

Who We Are


Arcellx isa public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our mission is to destroy cancer and advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible.Our team members are made up of talented innovators and dreamers working from our offices in Rockville, Maryland, and Redwood City, California.

At Arcellx, we hire exceptional people and create a fun, diverse, supportive, and informal environment that allows everyone to do their best work.

What Matters to Us


Living our core values is essential to maintaining a work environment that is high-performing, inclusive, and collaborative. We look for candidates who demonstrate strong values alignment and bring different backgrounds, viewpoints, and abilities to the team.Arcellx Core Values

  • Character: Committed to always doing what’s right.
  • Audacity: Willing to challenge convention and share candid feedback with others.
  • Determination: Curious and self-motivated. Always looking to improve and learn.  
  • Collaboration: "No job is too small" mentality. Humble and willing to help others.
  • Originality: Will bring your unique perspective to the table and respect a diverse set of views and backgrounds.

The “Fine Print” – What You’ll Do


  • 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 and Experience We Look For


  • 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.

Rewards at Arcellx


Our people are our greatest asset, and supporting their well-being is an essential part of delivering on our mission and impacting the lives of patients. Putting this belief into practice means offering strong compensation and benefits.The base salary range for this position is $180,000 - $195,000 per year. Where a candidate falls within that range is determined by factors such as years of experience. Our compensation package also includes an annual bonus based on company goals and an equity (RSU) grant.

We do offer relocation assistance for roles if required.Our market-leading benefits package includes: 100% coverage for medical, dental and vision for team members and dependents, unlimited vacation, a 3-day weekend every month, fully-paid parental leave for up to 6 months, tuition reimbursement, 401k employer contribution and more. 

Join us in our quest to reimagine cell therapy and destroy cancer. For more on our technology, culture, and team, go to


www.arcellx.com


.


 #LI-Onsite

Life at Arcellx

Arcellx is a clinical-stage biopharmaceutical company developing novel, adaptive and controllable cell therapies for the treatment of patients with cancer and autoimmune diseases. The Company's proprietary ARC-sparX platform separates the tumor-recognition and tumor-killing functions of conventional CAR-T cell therapies: (1) sparX (soluble protein antigen-receptor X-linkers) proteins recognize and bind specific antigens on diseased cells and flag those cells for destruction; and (2) ARC-T (Antigen Receptor Complex-T) cells bind the sparX proteins and kill the flagged cells. Arcellx has developed a collection of sparX proteins that bind different cell surface antigens. Administration of alternate sparX proteins can redirect ARC-T cells to different disease antigens to potentially address relapsed and refractory disease due to tumor heterogeneity or antigen escape. Additionally, ARC-T cell activity can be curbed as needed by controlling the dose and frequency of sparX administration.
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