Clinical Data Manager

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 ( 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 , 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 (, 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 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.
30+ days ago