At Allucent™, we are dedicated to helping small to medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are seeking a Senior Clinical Data Manager (SrCDM) to join our A-team in a hybrid or remote capacity. As a SrCDM, you will lead data management activities within the Allucent Data Management (DM) department. This role involves managing, coordinating, reviewing, and approving DM deliverables from database design and setup through to cleaning and reporting, ensuring that the completeness, accuracy, and consistency of clinical data meet quality standards and regulatory requirements for analysis and reporting. You will also provide expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff.

• 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, budget, and revenue recognition.
• Develop, review, and maintain project-specific DM documents, including data management plans and external data transfer agreements.
• Lead and coordinate the development of clinical study database setups, including eCRF design and database validation requirements.
• Participate in the review of study documents and coordinate the review of electronic case report forms (eCRFs).
• Oversee and ensure the successful completion of database User Acceptance Testing (UAT) tasks.
• Create training materials for EDC users and provide project-specific training.
• Lead the review and validation of clinical data for consistency, accuracy, integrity, and completeness.
• Develop data cleaning strategies and oversee data releases.
• Perform and coordinate various data transfers and reconciliation activities.
• Provide project metric reports, status updates, and feedback to project teams.
• 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.
• Recognize and solve potential problems, evaluating effectiveness.
• Maintain DM study documentation and ensure all filing is up to date.
• Prepare necessary documentation for internal and external audits and participate in such audits as assigned.
• Help align data management and clinical programming best practices within the company.
• Provide leadership, expertise, and support to other department members.
• Propose and support initiatives for improving efficiency.
• Actively support staff learning and development within the company.
• Share relevant information at departmental meetings and lead DM-related discussions.
• Represent the company at professional meetings, webinars, or seminars.
• Train and mentor data management staff and support the development of new training materials.
• Participate in the interview process for new recruits.
• Track Data Management-related regulatory developments and updates.
• Contribute as a Clinical Data Management Subject Matter Expert (SME) to process evaluations and improvements.
• Ensure good communication and relationships with clients.
• Contribute to client evaluations and visits and support the preparation of new proposals and budgets for Data Management services.
• Contribute to other areas of the business as required.