Senior Manager, Clinical Data Management

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.brHieronder staat alles wat u moet weten over wat deze vacature inhoudt, en wat er van sollicitanten wordt verwacht.brWe are looking for a Sr. Clinical Data Manager (SrCDM) to join our A-team (hybrid*/remote). As a SrCDM at Allucent you lead data management activities of the Allucent Data Management (DM) department. This position manages, coordinates, reviews and approves DM deliverables from database design set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting.   This position also provides expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff.brIn this role your key tasks will include:br
- Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites) br
- Plan and project the resources required including management of tasks, timelines, risk and quality br
- Monitor tasks against and keep track on budget, forecasts and manage changes of scope, budget, revenue recognition.br
- Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements br
- Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements br
- Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs) br
- Coordinate, oversee and ensure the database User Acceptance Testing (UAT) related tasks are successfully completedbr
- Create training materials for EDC users and provide project-specific training as required br
- Lead and oversee the review and validation of clinical data to ensure consistency, accuracy, integrity and completeness br
- Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock)br
- Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data br
- Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliancebr
- Organize and lead Quality Review activities during studybr
- Assist in project-related contracts negotiation and contracting process with vendors (EDC, IRT, eCOA)br
- Manage the database maintenance, lock and close-out processes and procedurebr
- Participate in conference calls and/or meetings with vendors and sponsorsbr
- Recognize and solve potential problems and evaluate effectivenessbr
- Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date br
- Plan and create necessary documentation to support internal and external audits; may participate in such audits assignedbr
- Help to align data management and clinical programming best practices, standards and conventions within the companybr
- Provide leadership, expertise and support to other department members. br
- Propose and support initiatives for improving efficiencybr
- Actively support to staff learning development within the companybr
- Share relevant information at applicable DM departmental meetings and organize and lead DM-related meetings and discussions br
- Represent the company at professional meetings, webinars or seminarsbr
- Train and mentor data management staff, support in development of new training material and provide training to relevant staffbr
- Participate in the interview process for new recruits br
- Proactively track Data Management related regulatory development trends and updates, in consultation with department Global Head and/or Director, for further alignment and improvement of current processes br
- Contribute as Clinical Data Management Subject Matter Expert (SME) to the evaluation/improvement/drafting of processes and procedures within the Quality Management Systembr
- Assure good communication and relationships with (future) clientsbr
- Contribute to and take part in client evaluations and visitsbr
- Support in preparation of new proposals and budgets for Data