Clinical Data Manager I

Responsible for the execution and adaptation of clinical data management plans and processes for collection, management, reporting and analysis of data on behalf of project teams and sponsors. Collaborate with multi-functional project teams and functional specialists to identify, modify, maintain, test, and review project databases, data, and related templates (CRF/eCRF) documents, reports and time lines. Regularly review quality of data output ensuring all data created meets integrity, quality, validity, and reliability standards and is collected, compiled, tested, and reported on in accordance which project and sponsor guidelines, industry best practices and regulatory standards. Liaise with sponsors, sites, and project teams to address data issues and queries; ensure stakeholders remain current on project requirements and manage sponsor expectations.

Product Support

• Customize and/or adapt existing templates to define data management plan(s) (objectives, design, requirements, time-lines, and role definitions), associated documents (CRF/eCRF, medical dictionary, quality systems, security, data transfer agreement), data design (platform, data sets, flow, entry, queries, transfer, frequency and testing) and deliver related training as required to align with project objectives, sponsor guidelines, best practices and regulatory standards

eCRF/CRF and Database Development

• Collaborate with database developers, project leaders, and sponsors to prepare, modify, test, manage, maintain, and report on the validity, functionality and quality of databases, data and data collection tools, troubleshooting data and submission errors, monitoring data preparation (cleaning, analysis, and standardization), completing quality control activities
• Reporting and/or recommending revisions or scope changes

Customer Service

• Regularly communication and/or respond to data collection sites, third party service providers, and when appropriate sponsors; responding to queries in a timely manner, addressing data collection and/or quality issues effectively ensuring customer expectations are managed appropriately and data-related communications/updates remain current and relevant.

Data Collection and Documentation

• As a member of the project team manager/monitor the preparation, collection, documentation, and sign-off processes including testing samples and results, edit report documents, training materials, data error tolerances, metadata, DMP revisions, data query process, data listings, SAE identification, capture and reconciliation guidelines, data audit, lock and transfer processes, and plan/version changes, ensuring alignment with project and regulatory requirements.

Qualifications

• Applicants should have a minimum of one to three years of related experience, ideally in a clinical research environment.
• A minimum of a one-year post-secondary certification/diploma/degree in a relevant field of study.
• The successful candidate must exhibit the following skills: Knowledge of Statistical Analysis (SAS) testing and ICH-GCP guidelines, skilled in the use of electronic database tools, systems, and coding dictionaries.

Working Conditions

• Home-based