Senior Manager, Clinical Data Management

Arcellx • Redwood City, CA

70d • $160,000 - $195,000

About The Position

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.

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.
• Review protocols for appropriate data capture including electronic (eCRF) design.
• Support CRF design, review, and validation of clinical database.
• Provide oversight of database set-up/migrations/upgrades including coordinating and/or performing User Acceptance Testing.
• Conduct oversight of data management vendors via ongoing review of quality and performance metrics.
• Generate, resolve, and track data queries to ensure the integrity of the clinical data.
• Facilitate and participate in data cleaning activities.
• Generate and/or review/approve study documents.
• Maintain internal data management timelines and metrics.
• Maintain study DM related documents/files for inspection readiness.
• Proactively identify potential data management issues/risks and communicate it within the study team for further action.

Benefits

• 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.
• Annual bonus based on company goals.
• Equity (RSU) grant.
• Relocation assistance for roles if required.

What This Job Offers

• Job Type: Full-time
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees