Senior Clinical Data Management Associate

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

📋 Description

• Manage all facets of clinical data management studies from initiation to closure for Kite’s clinical development initiatives.

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

• Report directly to the Senior Manager of Clinical Data Management.

• Partner with teams to achieve project goals and timelines for clinical data collection, quality assurance, and reporting.

• Oversee 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 data structures.

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

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

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

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

• Develop and manage timelines for data management.

• Provide expertise in Clinical Data Management for external vendor data coordination, collection, and cleaning.

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

• Continuously review clinical data to ensure quality standards are met.

• Assist vendors in implementing routine clinical data management processes, including data entry, quality checks, data transfers, and reporting.

• Create or support the development of Data Transfer Plans and other external data documentation.

• Manage and coordinate external data deliverables.

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

• Ensure compliance with standard business processes within CDM systems and adherence to regulatory body 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 deliver presentations.

• Delegate responsibilities to appropriate staff members.

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

⛳️ Requirements

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

• Experience in Clinical Data Management within oncology and knowledge of hematological cancers/cell therapy.

• Scientific background with experience in handling lab data.

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

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

• Strong problem-solving skills.

• Outstanding people and project leadership abilities.

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

• Proficient in web-based Electronic Data Capture systems, such as Medidata Rave and other clinical data management platforms.

• Excellent verbal, written communication, and interpersonal skills.

• Ability to convey critical technical aspects of CDM to non-CDM staff clearly.

• Flexibility to adapt to changing priorities, maintain attention to detail, work effectively under pressure, and tackle unfamiliar tasks.

• Proven skills in facilitating meetings and delivering presentations.

• Demonstrated capability to delegate tasks appropriately to relevant staff members.

• Proven ability to identify, communicate, and escalate project-level issues effectively.

• Must have eligibility to work in the United States, as this role is based in the United States.

🏝️ Benefits

• Eligibility for discretionary annual bonuses.

• Eligibility for discretionary stock-based long-term incentives, which may vary based on role.

• Paid time off.

• Company-sponsored medical insurance.

• Company-sponsored dental insurance.

• Company-sponsored vision insurance.

• Company-sponsored life insurance.

• Inclusive work environment.

• Reasonable accommodations in the job application process.