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.
Job Tags
Permanent employment, For contractors,