Senior Clinical Project Manager (Contractor)

Company: Arcellx, Inc.
Location: Redwood City
Posted on: March 15, 2023

Job Description:

Arcellx, Inc. (http://www.arcellx.com/) 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 our mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible. Our offices are located in Gaithersburg, Maryland, and Redwood City, California.
Arcellx's lead product candidate, CART-ddBCMA, is being developed for the treatment of relapsed or refractory multiple myeloma (r/r MM) in an ongoing study. CART-ddBCMA has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the U.S. Food and Drug Administration.
Arcellx is also advancing its dosable and controllable CAR-T therapy, ARC-SparX, through two programs: ACLX-001 for r/r MM and ACLX-002 in relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome.
We are looking for a seasoned Senior Clinical Project Manager (CPM) to join us as a contractor and be a key contributor to a multi-disciplinary team through the lifecycle of the studies from design through final analysis and study closeout. The successful contractor will oversee our clinical trials from study design through close out; establishing and managing relationships with assigned investigator sites, vendors, and consultants to ensure timelines and deliverables are met and that studies are conducted in accordance with appropriate regulatory requirements.
At Arcellx, we value passion, curiosity, determination, and diversity, and look for candidates who demonstrate a genuine interest in our mission and alignment with our values.
Key Responsibilities:

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• Act as primary CPM for one or more assigned studies.
  
• Provide input into protocols, amendments, and informed consent forms during all aspects of the studies.
  
• Assist with selection of vendors and provides oversight to vendors during study start-up through closeout.
  
• Measure all study related activities by reviewing performance metrics and quality.
  
• Work independently to ensure studies are conducted within budget and timelines and provides necessary updates and metrics to senior management. Conduct ongoing review of expenses.
  
• Oversee preparation of all trial related documents including study management plans and provide input to ensure quality oversight of the project(s).
  
• Provides oversight of Trial Master File to ensure completeness during all aspects of the study.
  
• As primary sponsor contact for study team and investigators, manages relationships with sites, vendors, and other internal and external team members.
  
• Participate in process improvement activities resulting in increases in productivity, quality, and/or cost effectiveness
  
• Provides input in ongoing and final clinical data review in conjunction with Data Management.
  
• Recommend strategies for, and oversee, the execution of activities associated with clinical monitoring, safety, eligibility, enrollment, and data consistency.
  
• Lead and/or contribute to department initiatives and assists in the design and implementation of standardized work processes as applicable.
  
  Qualifications:
  
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  • Minimum of 8 years of clinical project management experience in the pharmaceutical industry working in oncology.
    
  • Expert and knowledgeable regarding GCP and regulatory requirements.
    
  • Proficient with Medidata RAVE.
    
  • Superior communication skills, both verbal and written.
    
  • Experienced using Microsoft Office applications (Word, Excel, PowerPoint, etc.)
    
  • Strong organizational skills and ability to prioritize tasks.
    
  • Ability to work independently with minimal supervision.
    
    Competencies:
    
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    • Has character and integrity. Committed to always doing what's right.
      
    • Self-motivated and able to work autonomously. Can produce top-quality work with little oversight.
      
    • "No job is too small" mentality. Humble and willing to help others.
      
    • Able to build strong relationships and collaborate effectively with colleagues.
      
    • Gives direct, candid, and respectful feedback. Can receive feedback with curiosity and without getting defensive.
      
    • Always looking to improve and challenge the status quo. Gritty and determined.
      
      

Keywords: Arcellx, Inc., Redwood City , Senior Clinical Project Manager (Contractor), Healthcare , Redwood City, California