Clinical Data Leader

Clinical Data Leader

Treeline Biosciences
Treeline Biosciences, a clinical-stage biotechnology company, is seeking a skilled Clinical Data Leader to join our dynamic team. This role offers the opportunity to make a meaningful impact on cutting-edge research while ensuring compliance with industry standards and advancing best practices in data management.

About the Position

The Clinical Data Leader will play a central role in overseeing clinical data management activities to support the successful execution of clinical trials. The individual will collaborate with cross-functional teams, manage vendor/CRO activities, and ensure data quality and integrity throughout the clinical data lifecycle. The ideal candidate will have a strong understanding of clinical trial processes, regulatory guidelines, and technical systems, with a focus on delivering high-quality results aligned with Treeline’s innovative research goals.

Responsibilities

• Clinical Data Management:
• Lead the development of Data Management Plans (DMP), Data Transfer Plans/Agreements, Case Report Forms (CRFs), CRF Completion Guidelines, Edit Check Specifications, User Acceptance Testing (UAT) plans, and other key documentation.
• Manage data cleaning and validation processes, including discrepancy management, medical coding, and data reconciliation.
• Oversee database lifecycle activities from setup to lock and closeout, ensuring quality and compliance.
• Collaboration and Vendor Oversight:
• Collaborate with cross-functional teams, including Biostatistics, Clinical Operations, and Medical Monitoring, to ensure seamless study execution.
• Manage and coordinate work performed by vendors/CROs, ensuring deliverables meet quality standards and timelines.
• Collaborates cross functionally and with CRO’s to ensure SAE/AE reconciliation
• Interacts with clinical sites to ensure timely review and sign off of data for data cuts
• Provide feedback on vendor performance and support vendor selection processes, including RFP reviews and site audits.
• Process Development and Improvement:
• Contribute to the development and continuous improvement of data management processes, including SOP creation and updating.
• Develop and manage KPIs for data quality, process adherence, and productivity.
• Evaluate and implement new tools, systems, and best practices to improve data management efficiency.
• System Testing and Data Review:
• Create and review UAT scripts for EDC and eCOA systems, ensuring quality and completeness.
• Execute UAT to validate system setups, screen configurations, and edit checks.
• Lead internal study team reviews to ensure data quality and compliance with internal and regulatory standards.
• Project and Resource Management:
• Serve as the primary Study Data Manager for assigned clinical trials, ensuring timely and accurate data deliverables.
• Support strategic planning and resource allocation to meet study goals.
• Manage departmental budgets and ensure adequate resources for team development and study execution.

Qualifications

• Education and Experience:
• Bachelor’s degree in Life Sciences, Health Informatics, or a related field; advanced degree preferred.
• 7+ years of clinical data management experience in the pharmaceutical or biotechnology industry.
• Technical Skills:
• Proficiency with EDC systems (e.g., Medidata RAVE, Veeva EDC) and clinical data management tools.
• Strong knowledge of ICH-GCP guidelines, CDISC standards (CDASH, SDTM), and FDA regulations.
• Experience with medical coding (MedDRA, WHO Drug) and data transfer specifications for labs, ECGs, and biomarkers.
• Experience with IRT and EDC integrations.
• SAS programming experience is a plus.
• Core Competencies:
• Oncology experience preferred.
• Demonstrated success in managing vendor/CRO relationships.
• Strong organizational, analytical, and project management skills.
• Detail-oriented with a commitment to producing high-quality work.
• Excellent communication and interpersonal skills, with the ability to work collaboratively in a fast-paced environment.

Treeline Biosciences offers a dynamic and innovative work environment with opportunities to contribute to groundbreaking research. Join our team to make a meaningful impact on the development of life-changing therapies.

 

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