Principal Clinical Data Manager (Pr. CDM)

Vor Ort
8 Monate
Reutax AG
flag_no Deutschland
Philipp Dombrowski

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TITLE: Principal Clinical Data Manager (Pr. CDM)

Start: 16.07.12
End: 31.03.12
Place of work: Raum Frankfurt

To perform project management tasks within DM for trials and projects. To represent DM on the Trial Team. To be responsible for the creation of the CRF and key documents like the Data Management Plans, Reports and other documents, to perform data cleaning activities of in-house trials. To provide training. To supervise CRO activities regarding details of data collection, handling and transfer. Ensure database is ready for lock. Assure quality of data by establishing and administering of guidelines and standards for data management. To lead process and technology improvement and re-engineering initiatives. When applicable, lead and manage a team of CDCs and or CDMs.

Global Clinical Operations, Trial Teams, DM staff, DM managers, users of systems owned or managed by DM, Corporate Information Services, Corporate External Services
DM vendors, users of systems owned or managed by DM, Contract Research Organizations, Site Personnel

A. Trial activities:
o Coordination
• Perform Project Data Manager tasks as assigned
• Represent DM on the Trial Team and Project Team, be the DM contact person for the CROs
• Collaborate with the trial team for the establishment of trial timelines
• Define data management timelines
• Review and comment as appropriate on the trial protocol and Statistical Analysis Plan
• Contribute to the assessment and selection of CROs
• Ensure the surveillance of Data Management CROs during all phases of clinical trials
• Review and approve all relevant data management documents created by the CRO
• Ensure adherence to project standards
• Review trial specific Data Entry Conventions and other relevant documents for in-house trials
• Coordinate and monitor the progress of all DM tasks on a trial and update the individuals responsible for the project as appropriate
• Lead regular DM meetings to communicate timelines and ensure team members are following appropriate procedures and completing tasks as scheduled
• For in-house trials, create and maintain DM trial documentation, including the Data Management Plan and its attachments
• Train DM team on trial specific relevant data management documents
• Assist Help Desk in solving site questions or issues (EDC)
• Ensure appropriate user accounts (EDC)
• Forecast and monitor trial specific DM resources
• Communicate with external data providers regarding data structures and timelines for receipt of data transfers
• Communicate trends in data completion and quality to the Trial Team, and in particular to the Clinical Trial Leader and Lead Monitor
• Coordinate validation of databases, screens and edit checks programs as applicable
• For in-house trial, write the Data Management Report at completion of trials
• Review the trial report as applicable
• Provide relevant documentation for the Trial Master File
• Ensure archiving of the trial database
• CRF creation
• Coordinate CRF development following general and specific standards (therapeutic area of phase) and input of the Trial Team
• Database creation (for in-house trials)
• Define and create data specifications
• Create or coordinate the creation of the annotated CRF
• Validate data entry screens and data tables and document the outcome
• Edit check creation (for in-house trials)
• Create and maintain the Data Validation Plan
• Validate edit check programs and document the outcome
• Data Cleaning
• Review data according to the Data Validation Plan (for in-house studies)
• Create listings for data review
• For in-house studies, resolve data discrepancies
• Coordinate quality control of CRF/DCF (for the paper process) or Portable Document Format (PDF) (for the EDC process) data vs. database (1:1 check)
• Communicate data issues to the team to ensure resolution
• Ensure the integration of external data
• Review and reconcile external and non-CRF data with the clinical database
• Freeze/Unfreeze and lock/unlock specific eCRF screens (EDC)
• Contribute to the protocol deviation detection
• Review findings communicated by the trial Biostatistician/ Statistical programmer and take appropriate actions (raise query or clarify to Biostatistician/ Statistical programmer)
• Participate in the Blind Data Review Meeting and provide input as needed
• Ensure database is validated and ready to lock
• Collaborate with Global Biostatistics to un-blind the data

B. Non trial activities:
• Contribute to the assessment and selection of Partner CROs
• Administration
• Represent the line manager when requested
• When applicable, lead a team of CDCs and CDMs, including:
• Assist with staff development and training plans
• Motivate and build team spirit
• Distribute work assignments
• Determine resource allocation and hiring needs
• Work with line management and Trial DMs to ensure adequate resource allocation and prioritization to meet project timelines
• Ensure consistency and harmonization in DM work and deliverables across trials and sites within a project
• Ensure compliance of the team with quality standards, guidelines and procedures
• System maintenance and process improvements
• Lead and contribute to the continuous improvement, re-engineering and implementation of processes, tools, technologies, conventions, standards, policies, Standard Operating Procedures (SOPs), and Working Instructions (WIs) as needed
• Lead and contribute to the assessment and selection of Data Management software systems
• Training – Receiving
• Keep up to date with job related topics
• Be up to date with SOPs, WIs, and user manuals and maintain training log
• Training – Providing
• Mentor CDMs, and CDCs
• Train CDMs and CDCs
• Provide training at investigator meetings
• Prepare and conduct presentations
• Provide training at investigator meetings
• Prepare and conduct presentations


Master or Diploma of Science preferred
Excellent knowledge of English
Proven experience as Clinical Data Manager in the pharmaceutical/biotechnology industry, equivalent to 6 years
Successful completion of multiple studies from beginning to end providing a full scope of DM experience
Proficiency with data management systems such as ClinTrial™, InForm™
Basic knowledge of SQL is a plus
Good knowledge of SAS
Understanding of relational database design
Proficient Computer Skills e.g. word processing, spreadsheets
Knowledge of medical terminology required
Excellent knowledge of regulations and guidance with regard to clinical development and the systems used in this context

Darüber hinaus werden noch mehrere „Clinical Data Programmers“ und „Clinical Coding Experts“ gesucht. Die Eckdaten (Start/Ende, etc.) sind identisch.

Sollten Sie an diesem Projektangebot interessiert sein, so freue ich mich auf die Zusendung Ihres aktuellen CVs im Word-Format, inkl. All-in Stundensatz und Ihrer Verfügbarkeit.

Gerne stehe ich Ihnen für weitere Rückfragen zur Verfügung.

Mit freundlichen Grüßen

Philipp Dombrowski