Associate Clinical Data Manager

Position: Associate Clinical Data Manager
Department: Data Management
Therapy Area: Oncology
Location: Prague
Employment Type: Full time employment

 

Position Summary:

The Associate Clinical Data Manager serves as a Data Management contact with sponsors and represents the department in the different project teams.  He/she is responsible for ensuring clinical study databases are build, tested and validated, data cleaning activities are performed on an ongoing basis from study initiation through database lock, and data is archived. The Associate Data Manager supports in coordinating the receipt and processing of all study related data including data from external service providers and provides overall status updates to the relevant project team.

In addition, it is her/his responsibility to ensure the Data Management processes and systems used during the life time of a study are properly documented and comply with regulatory requirements.

 

Key Activities and Responsibilities:

  • Provide input in 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).
  • Supports 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.
  • Supports 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 and which accurately reflect process deviations and changes in project assumptions.
  • Provides input in evaluating 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.
  • 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.
  • As a key member of the Data Management department, provides input  in defining processes, procedures related to operational effectiveness of the used Clinical Data Management Systems

 

Competences, Skills and Qualification:

  • Expertise in translating protocol requirements into eCRF design
  • Experience with EDC systems, understanding of relational Databases
  • Exposed to standardized CRFs libraries
  • Basic knowledge of CDISC-SDTM data standardization specifications
  • Experienced in all Data Management aspects like query management, document creation and review, etc…
  • 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 clients and other departments’ representatives
  • Demonstrating pro-active and independent delivery of tasks
  • Proficiency with Microsoft Office (Excel, Word, PowerPoint, and Outlook)
  • Good verbal and written communication skills and English fluency

 

Preferred Qualifications:

  • Bachelor’s degree in medical, scientific, biological, statistical, computer science, or related field or equivalent through experience
  • Two years of relevant clinical trial Data Management experience in the pharma/biotech industry

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