At Allucent™, we are committed to assisting small to medium biopharmaceutical companies in effectively navigating the complexities of clinical trials to deliver transformative therapies to patients worldwide. We are seeking a Senior Clinical Data Manager (SrCDM) to join our exceptional team in a hybrid/remote capacity. In this role, you will oversee data management activities within the Allucent Data Management (DM) department, managing, coordinating, reviewing, and approving DM deliverables from database design and setup through to cleaning, reporting, and database locking. You will ensure that the completeness, accuracy, and consistency of clinical data align with quality standards and regulatory requirements for analysis and reporting. Additionally, you will provide expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and staff training.

• Lead and act as the primary contact for DM with all relevant internal parties (e.g., Clinical Programmers, Data Scientists, Project Management, Clinical Operations, Biostatistics) and external parties (e.g., sponsors, vendors, investigational sites).
• Plan and project resource requirements, managing tasks, timelines, risks, and quality.
• Monitor tasks against budget, forecasts, and manage changes in scope and revenue recognition.
• Develop, review, and maintain project-specific DM documents including data management plans (DMP), eCRF specifications, and data validation plans (DVP).
• Lead and coordinate the setup of clinical study databases, including eCRF design and validation requirements.
• Participate in the review of study documents and coordinate the review of electronic case report forms (eCRFs).
• Oversee database User Acceptance Testing (UAT) tasks to ensure successful completion.
• Create training materials for EDC users and provide project-specific training as needed.
• Review and validate clinical data to ensure consistency, accuracy, integrity, and completeness.
• Create data cleaning strategies in consultation with relevant functional groups and oversee data releases.
• Perform and coordinate various data transfers and reconciliation activities.
• Provide project metric reports, status updates, and feedback on site performance issues and data trends.
• Organize and lead Quality Review activities during studies.
• Assist in project-related contract negotiations with vendors.
• Manage database maintenance, lock, and close-out processes.
• Participate in meetings with vendors and sponsors.
• Identify and resolve potential problems, evaluating effectiveness.
• Maintain DM study documentation and ensure all filing is current.
• Prepare documentation for internal and external audits and participate in audits as assigned.
• Align data management and clinical programming best practices within the company.
• Provide leadership and support to other department members and propose initiatives for efficiency improvements.
• Actively support staff learning and development within the company.
• Share relevant information at DM departmental meetings and lead DM-related discussions.
• Represent the company at professional meetings, webinars, or seminars.
• Train and mentor data management staff, supporting the development of new training materials.
• Participate in the recruitment process for new hires.
• Track regulatory development trends in data management and consult with leadership for process improvements.
• Contribute as a Clinical Data Management Subject Matter Expert (SME) to the evaluation and drafting of processes within the Quality Management System.
• Ensure effective communication and relationships with clients and contribute to client evaluations and visits.
• Assist in preparing proposals and budgets for Data Management services and contribute to other business areas as needed.