Senior Clinical Data Manager I

hace 3 semanas

Madrid, España Allucent A tiempo completo

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment.

The Senior Clinical Data Manager I (CDM I) leads and coordinates Data Management (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 leadership and expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff.

The Senior CDM I is a member of the Data Management staff.

**Key Responsibilities**

**_ Data Management_**
- Serve as primary contact for DM with all relevant parties both internally (e.g. Project Management, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, external vendors, investigational sites)
- Plan and project the resources required including management of tasks, timelines, risk and quality
- Keep track on budget, forecasts and manage changes of scope requests
- Participate in the review of study documents (e.g. protocol, (electronic) case report forms (eCRFs), safety plans/manuals and statistical analysis plan)
- Provide support on clinical study database set-up, including eCRF design and database validation requirements
- Develop, review and maintain project-specific DM documents including data management plans (DMP), eCRF, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements
- 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
- Create data cleaning plan in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock)
- Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance etc.
- Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data
- Perform medical coding tasks as needed
- Participate in conference calls and/or meetings with vendors and sponsors
- Manage the database implementation, lock and close-out processes and procedures
- Maintain 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; participates in such audits
- Provide leadership, expertise and support to other department members.
- Recognize and solve potential problems and evaluate effectiveness

**_Learning & Development_**
- Actively support staff learning & development
- Develop and deliver applicable DM departmental training
- Participate in the interview process for new recruits
- Train and mentor data management staff
- Proactively track data management development trends and updates, in consultation with department Global Head and/or Directors, for further alignment and improvement of current processes

**_Quality Management_**
- Contribute as Subject Matter Expert (SME) in the field of CDM activities to the evaluation/improvement and standardization of processes and procedures within the Quality Management System

**Requirements**:
**Qualifications**
- Life science, healthcare and/or related field degree
- Minimum 5-10 years of relevant work experience
- Minimum 5-10 years of experience in drug development and/or clinical research
- Basic knowledge of ICH-GCP(R2), GDPR/HIPPA and applicable (local) regulatory requirements
- Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation)
- Experience in CDISC conventions, i.e., CDASH, SDTM model and hands on experience implementing these models
- Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies
- Ability to translate guidelines, rules and regulations in clear and usable recommendations

**Skills**
- Strong written and verbal communication skills including good command of English language
- Representative, outgoing and client focused
- Ability to work in a fast-paced challenging environment of a growing company
- Administrative excellence
- Strong project managem

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