Jobs at Accent Therapeutics

The Director, Clinical Data Management (CDM) is responsible for oversight, execution, and quality of all data management activities across assigned clinical trials from study start-up through database lock. This role ensures the integrity, completeness, and regulatory compliance of clinical trial data while leading cross-functional collaboration, CRO oversight, and continuous process improvement.

• Serve as the data management lead on cross-functional study teams.
• Oversee the collection, validation, reconciliation, and processing of clinical trial data from first patient through database lock.
• Ensure synchronization of data management timelines with overall clinical study timelines.
• Provide oversight of CROs and external service providers; monitor performance, deliverables, and quality metrics.
• Participate in vendor selection and contract evaluation for outsourced data management activities.
• Contribute to departmental initiatives, SOP development, process optimization, and technology enhancements.
• Develop, review, and approve key study documents, including the data management plan, case report forms, database build specifications, data transfer specifications, and SAE reconciliation plans.
• Design and oversee electronic Case Report Forms (eCRFs) and Electronic Data Capture (EDC) systems.
• Oversee database build, migration, updates, validation testing, and User Acceptance Testing (UAT).
• Develop and execute data validation checks and quality control procedures.
• Lead routine data review and cleaning, discrepancy management, and query generation/resolution.
• Generate and review data listings, summaries, metrics, and reports to support interim analyses and clinical study reports.
• Provide training on EDC systems, CRF completion guidelines, and data management processes to internal and external stakeholders.
• Contribute to a professional and collaborative working environment aligned with company values.

• Bachelor’s degree in health sciences, life sciences, mathematics, computer science, or a related scientific discipline; oncology/solid tumor clinical trial experience is a plus.
• ~5 years of progressive clinical data management experience in pharmaceutical, biotechnology, or CRO environments (depth of experience considered in lieu of minimum years).
• Strong expertise in clinical trial processes, data management principles, and regulatory requirements.
• Working knowledge of GCP, CDISC requirements, ICH, and FDA regulations.
• Hands-on experience with web-based Electronic Data Capture (EDC) systems and clinical data management platforms.
• Experience writing SQL queries to extract, review, and validate clinical trial data.
• Exposure to R and/or Python for data analysis, data review automation, or visualization.
• Experience with industry-standard dictionaries (MedDRA, WHO Drug).
• Familiarity with data analysis/reporting tools such as SAS, SQL, or similar systems.
• Proven CRO/vendor oversight experience.
• Excellent verbal and written communication skills.
• Strong analytical, problem-solving, and organizational abilities.

Preferred Qualifications

• Advanced degree in a related field.
• Experience contributing to or validating data management software tools.