Clinical Data Manager Job at Katalyst Healthcares & Life Sciences, Austin, TX

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  • Katalyst Healthcares & Life Sciences
  • Austin, TX

Job Description

Responsibilities:


  • Represents data management in study team meetings, able to facilitate and provide data management updates and/or input when appropriate.


  • Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines.


  • 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).


  • Reviews protocols for appropriate data capture including electronic Case Report Form (eCRF) design and external data vendors' systems.


  • Provides oversight of database set-up/migrations/updates including coordinating and performing UAT.


  • Leads the development of internal Data Review Plan and coordinates cross functional team data listing review.


  • Coordinates the internal medical coding review.


  • Performs ad hoc and scheduled data listing review and generates/resolves queries in EDC.


  • Performs external data reconciliation against EDC.


  • Performs Serious AE reconciliation according to SOPs and guidelines, as applicable.


  • Executes and/or distributes data management metrics, listings, and reports.


  • Provides oversight of 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.


  • Reviews and provides feedback to the clinical team on other study documents e.g., Clinical Monitoring plans and vendor specifications.


  • Provides training on the EDC system and/or CRF completion guidelines and EDC system to internal or external study team members, as needed.


  • Proactively identifies potential study issues/risks and recommends/implements solutions.


  • Maintains study DM related documents/files for inspection readiness.


  • Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.


  • Assists with the training of new employees and/or contractors (e.g., clinical data associates and/or junior clinical data managers working on the studies).


  • Participates in CRO/vendor selection process for outsourced activities.


  • Supports budget and resource planning across assigned projects.


  • Participates in the development, review and implementation of departmental SOPs, templates, and processes.


  • Participates in department or cross-functional initiatives (as needed).


  • Contributes to a professional working environment through exemplifying ResMed Core Values.


Requirements:



  • Bachelor's degree in health sciences, Life Sciences, Mathematics, Computer Sciences, or health-related field.


  • At least 9 years for Clinical Data Management experience in the pharmaceutical or biotechnology industry, depth and exposure to DM related tasks considered in lieu of minimum requirement.


  • Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements.


  • Good working knowledge of ICH, FDA, and GCP regulations and guidelines.


  • Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint).


  • Knowledge of industry standards (CDISC, SDTM, CDASH).


  • Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.


  • Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment.


  • Ability to handle multiple projects and prioritize effectively, well organized and detail oriented.


  • Proven ability to work both independently and in a team setting.

Katalyst Healthcares & Life Sciences

Job Tags

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