Senior Manager, Clinical Data Management at Arcellx

Redwood City, California, United States -

Full Time

Start Date

Immediate

Expiry Date

12 Jan, 26

Salary

195000.0

Posted On

14 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Data Management, Oncology Trial Experience, Regulatory Guidelines, Medidata RAVE, Data Visualization, Analytics, Communication Skills, Organizational Skills, Independent Work, Task Prioritization

Industry

Biotechnology Research

Description

Who We Are Arcellx is a 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 Start with authenticity: We foster an inclusive environment where each person can bring their authentic self to work. Think ‘we’ before ‘me’: We prioritize collective success, collaborating and supporting one another to achieve our shared goals. Embrace the challenge: We deliver exceptional results by working with shared determination and a commitment to doing what’s right. 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 estimated base salary range for this position is $160,000 - $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

Responsibilities

Act as the lead data manager across one or more clinical studies, providing oversight of all clinical database activities from design to closeout. Generate, resolve, and track data queries to ensure the integrity of the clinical data and maintain internal data management timelines.