Senior Clinical Data Management Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee all facets of clinical data management studies from initiation to completion for Kite's clinical development initiatives.

• Collaborate closely with Biostatistics, Programming, Clinical Operations, Safety, and Regulatory teams.

• Partner on project deliverables and timelines related to clinical data collection, quality assurance, and reporting.

• Manage multiple studies that are complex in both scope and volume.

• Lead studies and projects independently without supervision.

• Ensure the completeness, accuracy, and consistency of clinical data and its structure.

• Spearhead the preparation and design of electronic Case Report Forms (eCRFs).

• Review study protocols and either lead or assist in planning and executing the data management components of clinical studies.

• Engage with site coordinators, investigators, and field clinical personnel to gather data and address queries.

• Utilize reports to monitor study progress and uphold timeliness and quality standards.

• Prepare and oversee data management timelines.

• Provide expertise in clinical data management for coordination, collection, and cleaning of external vendor data.

• Oversee CDM deliverables in collaboration with both internal and external cross-functional teams.

• Continuously review clinical data.

• Support vendor processes, including data entry, quality checks, data transfer, and reporting.

• Create or assist with Data Transfer Plans and external data documentation.

• Manage and coordinate external data deliverables.

• Organize query management, report delivery, study timelines, and database snapshots for analysis, including Safety Review.

• Ensure compliance with standard business processes within CDM systems and regulatory requirements.

• Participate in the design and implementation of clinical data management processes.

• Act as a primary contact for the study management team.

• Facilitate meetings and presentations.

• Assign tasks to relevant team members.

• Identify, communicate, and escalate project-level issues related to processes, timelines, resources, and performance.

⛳️ Requirements

• High School diploma with over 9 years of experience in Data Management, OR a BS/BA in life sciences or a related field with 5+ years of experience in Data Management, OR an MS/MA in life sciences or a related field with 3+ years of experience in Data Management, OR a PhD in life sciences or a related field with 2+ years of experience in Data Management.

• Experience in CDM within oncology and knowledge of hematological cancers/cell therapy.

• A scientific background along with experience in lab data handling.

• Proven understanding of FDA, EMA, and ICH guidelines and regulations that pertain to clinical trials, statistics, and data management.

• Experience in managing clinical data management deliverables for regulatory submissions.

• Strong problem-solving abilities.

• Outstanding people and project leadership skills.

• Familiarity with industry-standard thesauri/dictionaries such as MedDRA and WHODD.

• Proficient in web-based Electronic Data Capture systems, including Medidata Rave and other clinical data management tools.

• Excellent verbal and written communication skills, along with strong interpersonal abilities.

• Capability to effectively explain critical technical aspects of CDM to non-CDM personnel.

• Adaptable to shifting priorities, detail-oriented, able to work under pressure, and willing to tackle unfamiliar tasks.

• Demonstrated skills in meeting facilitation and presentations.

• Proven ability to delegate tasks appropriately to team members.

• Demonstrated capability to identify, communicate, and escalate project-level issues.

🏝️ Benefits

• Eligibility for discretionary annual bonuses.

• Eligibility for discretionary stock-based long-term incentives.

• Paid time off.

• Company-sponsored medical insurance.

• Company-sponsored dental insurance.

• Company-sponsored vision insurance.

• Company-sponsored life insurance.