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Sr Manager, Clinical Data Manager

Arcellx Inc
Gaithersburg, MD
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Arcellx (http://www.arcellx.com/) is a clinical stage, publicly-traded biotechnology company focused on the development of novel cell-based cancer therapies. The company is in Gaithersburg, Maryland and the SF Bay Area has assembled a team of biotechnology professionals with expertise in biologics discovery, characterization, and clinical development.  Lead products will incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells.

Primary Objective

The Senior Data Manager works as an integral part of a cross-functional team through the lifecycle of the studies from design through final analysis and study closeout. The individual is accountable for ensuring study launch, conduct, and closeout are performed according to Arcellx’s quality standards, Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to to be compliant with all federal and local regulations.  

Main Accountabilities:

  • Act as Lead Data Manager across one or more clinical studies and lead all aspects of data management activities.  
  • 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.  May also conduct ongoing TMF review to ensure all data management-related documents are complete and filed. 
  • Generates, resolves, and tracks data queries to ensure the integrity of the clinical data with respect to data guidelines and protocol specifications.
  • Facilitates and participates in data cleaning activities. 
  • Generates and/or reviews/approves study documents (Data Management Plan, CRF Completion Guidelines, DB build specifications, Edit Check Specifications, Data Transfer Specifications, SAE and/or External Data Reconciliation Plans, Coding Guidelines, Vendor Management Plans, etc.)
  • Review CRF metrics reports against project data deliverables
  • 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.
  • Participate in process improvement activities resulting in increases in productivity, quality, and/or cost effectiveness
     
     

Preferred Qualifications:

  • Minimum BA/BS in scientific or health-related field.
  • Minimum of 5 - 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 (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to DM practice 
  • Proficient with Medidata RAVE.
  • Experience with  working on Medidata Suite products (Safety Gateway, ePRO, RTSM) preferred
  • Familiarity with various data visualization, analytics, and reporting tools is a plus
  • Excellent communication skills (verbal and writing). 
  • Ability to multi-task and take on new responsibilities as needed in a fast-paced, small company setting.
  • Experienced using Microsoft Office applications (Word, Excel, PowerPoint, etc.)
  • Strong organizational skills and ability to prioritize tasks. 
  • Proven ability to work independently and in a team setting. 

 

Competencies:

•    Commitment to ethical scientific investigations and rigorous experimental methods.

•    Ability and desire to multitask and function in a fast-paced entrepreneurial environment.

•    Sense of urgency in performance of duties.

•    Interpersonal skills that promote a collaborative and productive lab environment.

•    Effective and efficient written and oral communication skills.


 Submit cover letter and resume

Without exception, applicants must submit both a cover letter and resume to be considered for these positions and must have experience in one of the fields listed above.

 

Arcellx Inc

Address

Gaithersburg, MD
20878 USA

Industry

Healthcare

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