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
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