Senior Clinical Data Specialist. Phoenix Move Collective

Join Sumitomo Pharma Co., Ltd., a leading global pharmaceutical company headquartered in Japan, dedicated to addressing patient needs in diverse therapeutic areas such as oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. Our commitment to innovation is reflected in our extensive portfolio of marketed products and a growing pipeline of investigational assets aimed at accelerating the delivery of novel therapies to patients.

This role reports to the Associate Director, Clinical Data Management, Oncology, within the Oncology Data Management team, which is vital in ensuring accurate, compliant, and complete clinical trial data for Sumitomo Pharma America's clinical development initiatives. As a Senior Clinical Data Specialist, you will manage multiple oncology studies with increased independence and accountability, playing a key role in enhancing data quality, meeting timelines, and ensuring inspection readiness through close collaboration with Clinical Operations, Safety, Biostatistics, and external vendors.

• Perform comprehensive clinical data review activities, including query generation, review, follow-up, and closure according to study guidelines and timelines.

• Conduct in-house data reviews and provide constructive feedback to the Lead/Clinical Data Manager or CRO Data Management team.

• Contribute to eCRF design, system validation activities, and ongoing EDC updates in partnership with external vendors.

• Assist in creating, reviewing, and maintaining essential Data Management documentation such as:

  • Data Management Plans (DMPs)
  • CRF Completion Guidelines
  • Data Validation Specifications / edit checks
  • Data Cleaning and Reconciliation Plans

• Manage reconciliation activities (e.g., SAE reconciliation), raise and track queries, and elevate issues to Safety and Data Management leadership as needed.

• Support interim analysis and database lock activities through focused data cleaning and reconciliation deliverables.

• Assist in managing Lab Normal Ranges for studies involving local laboratories.

• Provide status updates to internal study teams during the absence of the Lead/Clinical Data Manager.

• Take ownership of assigned data management tasks and serve as the primary contact for selected projects or study components.

• Mentor and train junior Clinical Data Associates in their assigned tasks and Data Management procedures.

• Ensure strict adherence to Data Management standards, SOPs, and relevant regulatory requirements.

• Carry out additional duties that support departmental objectives.

• Strong understanding of clinical data management processes and clinical trial conduct under ICH/GCP.

• Hands‑on experience with EDC systems, query management, data cleaning, and reconciliation workflows.

• Exceptional attention to detail and ability to prioritize competing demands across multiple studies.

• Demonstrated ability to work independently while knowing when to elevate issues appropriately.

• Excellent written and verbal communication skills.

• Strong collaborative skills in a matrixed, cross‑functional environment.

• Proven ability to mentor and guide junior team members and share best practices.

• Bachelor's degree in life sciences or a related field is mandatory.

• At least 3 years of clinical data management experience in the pharmaceutical or biotech sector is required.

• Oncology experience is preferred.

• Willingness to travel is required.

The base salary range for this role is between $84,900.00 and $, part of a comprehensive total rewards package which includes opportunities for merit-based increases, an incentive plan, 401(k) eligibility, comprehensive medical, dental, and vision insurances, life and disability insurances, as well as generous paid time off and sick leave. Total compensation will depend on various factors unique to each candidate.

The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel classified in this role.