Clinical Data Manager - CDM

The Clinical Data Manager actively participates in all aspects of the data management process from the development of project documentation, system set-up, User Acceptance Testing (UAT), and routine data review through database lock of clinical trials. The CDM has a broad, fundamental knowledge of the data management process and can plan, manage, and coordinate activities for assigned tasks with minimal guidance. This person may have project level oversight as a study Lead Data Manager. The core duties and responsibilities of the CDM are delineated below

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  Manages data management duties to meet study timelines.
  
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  Review and may distribute/coordinate data management metrics, listings, and reports.
  
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  Performs scheduled and ad hoc data listing review and generates/resolves queries in EDC
  
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  Performs external data reconciliation against EDC.
  
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  Performs Serious AE reconciliation according to SOPs and guidelines, as applicable.
  
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  Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.
  
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  Generates and/or reviews/approves study documents (e.g., Data Management Plans, Case Report Forms, DB build specifications, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, laboratory data handling plan, study protocols).
  
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  Reviews protocols for appropriate data capture including electronic Case Report Form (eCRF) design and external data vendors’ systems.
  
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  Reviews and provide feedback to the clinical team on other study documents e.g.,Clinical Monitoring plans and vendor specifications.
  
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  Maintains study DM related documents/files for inspection readiness.
  
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  May oversee data management CRO/service providers including manages and monitors the progress of data management activities with CROs and/or other service providers on assigned studies; build effective relationships with CRO/service provider counterparts.
  
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  May assist with the training of new employees and/or contractors (e.g., clinical data associates and/or junior clinical data managers working on the studies).
  
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  May participate in CRO/vendor selection process for outsourced activities.
  
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  May participate in the development, review and implementation of departmental SOPs, templates, and processes.
  
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  Contributes to a professional working environment through exemplifying Core Values
  

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  Bachelor’s degree
  
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  At least three (3) years of CDM of Data Management experience in the pharmaceutical, biotechnology, or CRO industry; depth and exposure to DM related tasks considered in lieu of minimum requirement.
  
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  Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements.
  
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  Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
  
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  Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint).
  
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  Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
  
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  Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment.
  
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  Ability to handle multiple project tasks and prioritize effectively.
  
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  Well organized and detail oriented.
  
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  Proven ability to work both independently and in a team setting.
  

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  Bachelor's degree in health sciences, Life Sciences, or health-related field.
  
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  CRO/service provider experience desired.
  
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  Prior oncology/solid tumor experience.
  
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  Knowledge of industry standards (CDISC, SDTM, CDASH).