Clinical Data Manager Ii

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.

We are looking for a Clinical Data Manager II (DM II) to join our A-team (hybrid*/remote). As a Clinical DM II at Allucent, you will assist in data management related activities of the Allucent Data Management (DM) department. This position supports and performs DM-related activities 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..

**In this role your key tasks will include**:

- Assist in DM-related tasks and collaborate with Lead DMs and relevant roles within Data Management (e.g. Clinical Programmers, Data Scientists).
- May act as primary contact for DM with all relevant parties, both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Biostatistics and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites)
- Provide feedback and status updates to Lead DM regarding progress, timelines, risk and quality and plan and when assigned as lead CDM, project resources based on assigned tasks and projects
- Monitor tasks against and keep track on budget, forecasts, identify and trigger changes of scope requests
- Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements
- Provide support during clinical study database set-up, including eCRF design and database validation requirement and may lead these activities
- Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan)
- Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks
- Create training materials for EDC users and provide project-specific training as required
- Review and validate clinical data to ensure consistency, accuracy, integrity and completeness
- Participate in creating data cleaning strategy in consultation with applicable functional groups and assist in data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock)
- Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data
- Create and review project metric reports, status updates, study progress to Lead DM in order to share information on site performance issues, data trends and protocol non-compliance
- Support and conduct Quality Review checks during study. May organize and lead Quality Review activities on behalf of lead DM.
- Support and/or manage the database maintenance, lock and close-out processes and procedure
- May participate in conference calls and/or meetings with vendors and sponsors
- Recognize and solve potential problems and evaluate effectiveness
- Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date
- Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned
- Help to align data management and clinical programming best practices, standards and conventions within the company
- Propose and support initiatives for improving efficiency
- Actively support to staff learning & development within the company
- Share relevant information at applicable DM departmental meetings
- Contribute in the field of Clinical Data Management activities to the evaluation/improvement of processes and procedures within the Quality Management System
- Assure good communication and relationships with (future) clients
- Contribute to other areas of business as required

**Requirements**:
**To be successful you will possess**:

- Bachelor's degree in Life sciences
- Post Graduate degree from local university
- 5+ years of relevant work experience as Clinical Data Manager
- 5+ years of experience in drug development and/or clinical research
- 5+ years of EDC experience in Medidata Rave, Merative/Zelta-IBM)
- Clinical trial data experience specializing in various therapeutic areas such as: oncology, autoimmune, immunology, hematology, rare diseases, etc.
- Good knowledge of ICH-GCP, GDPR/HIPPA and applicable (local) regulatory requirements
- Good understanding of Medical Terminology
- Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies, familiar with IRT and eCOA
- Active participation and support in Data Management activities related to database setup, data cleaning and query management, external data reconciliation for at least 3 studies.
- Good understanding of relational database components and experience in tech