Clinical Data Manager
The Clinical Data Manager represents Data Management within the different project teams. He/she is responsible for ensuring clinical trial databases are build, tested and validated, data cleaning activities are performed on an ongoing basis from trial initiation through database lock, and data is archived. The Clinical Data Manager coordinates the receipt and processing of all trial related data including data from external service providers and provides overall status updates to the relevant project team.
In addition, it is his/her responsibility to ensure the Data Management processes and systems used during the lifetime of a trial are properly documented and comply with regulatory requirements. The Clinical Data Manager continuously evaluates the current processes, procedures and tools and formulates proposals for process improvement.
Key activities and responsibilities
- Participate/drive study set-up and initiation procedures such as eCRF design, database design, edit check design/review/UAT, and related Data Management documents.
- Ensure the proper collection, management, and storage of clinical trial data (according to regulatory requirements).
- Ensure proper clinical data validation, review and query management.
- Performs activities to complete project deliverables on schedule according to quality standards, from study start-up through archival.
- Coordinates receipt and handling of data received from external service providers and directs reconciliation where applicable.
- Maintains open communication with internal and external customers by contacting project team members on agreed-upon schedule, responding to correspondence promptly and within agreed timeframes and choosing method of communication based on urgency and type of information being communicated.
- Demonstrate positive working relationship with internal customers and sponsor by keeping them up to date about progress of projects and working with them to develop coordinated plans that meet customers’ needs.
- Maintains current study documentation which accurately reflect process deviations and changes in project assumptions.
- Evaluates project team requests by considering factors such as efficiency, quality, data integrity, resources, and customer relations before committing to an action; seeks out existing knowledge prior to developing new methods. Reach out to head of Data Management as appropriate.
- Continuously evaluates timelines in relation to work completed and communicates impact on milestones to head of Data Management and Project team. Develop project reports which meet needs of sponsors, project team, and head of Data Management.
- Recommends alternative work processes to improve quality or speed of customer deliverables and responds to questions on Data Management process, timelines, and data quality.
- Develops and maintains Data Management study files. Specifies data cleaning guidelines, conventions, Standard Operating Procedure (GSOP), data workflow, and other processes, which will be followed to meet sponsor requirements.
- Prepares in advance for internal and external meetings, completes action items within required timeframe, and attends internal meetings regularly, providing input, and demonstrating respect for opinions of others.
- Conducts post-mortem analysis after study completion/major milestone to determine positive and negative factors affecting the project and provides information along with study metrics to Head of Data Management.
- As a key member of the Data Management department, take active part in defining processes, procedures related to operational effectiveness of the used Clinical Data Management Systems
- In the event that colleague Data Managers will be supporting assigned studies:
- Maintains consistent, manageable workflow for colleague data managers in cooperation with head of Data Management.
- Monitors quality of work performed by colleague data managers and compliance with SOPs and provides feedback to team.
Competences, skills and qualification
Competences and skills
- Strong expertise in translating protocol requirements into eCRF design
- Experience with EDC systems, in depth understanding of relational Databases. Experience with IBMCD is a plus
- Experience with use of standardized CRFs libraries
- Basic knowledge of CDISC-SDTM data standardization specifications
- Proficient in all Data Management aspects like query management, document creation and review, etc…
- In depth understanding / knowledge of the drug development and clinical research process
- Familiarity with ICH GCP as well as general knowledge of industry practices and standards
- Good cooperation skills with internal and external
- Efficient in managing and coordinating of vendors, suppliers and CROs as needed
- Ability to proactively identify project threats and work out mitigation plans
- Demonstrating pro-active and independent delivery of tasks
- Proficiency with Microsoft Office (Excel, Word, PowerPoint, and Outlook)
- Excellent verbal and written communication skills in English
- Ability to identify areas needing development
- Experience in coding using MedDRA and WHODRUG is an advantage
- Bachelor’s degree in medical, scientific, biological, statistical, computer science, or related field
- Three years of relevant clinical trial Data Management experience in the pharma/biotech industry
- Experience in planning, setup, conduct and reporting of different stage clinical trials
- Practical expertise in all aspects of Data Management
- Client communication and reporting experience