Clinical Data Manager - FSP

When our values align, there's no limit to what we can achieve.

At Parexel , we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel , contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel FSP is hiring for multiple Clinical Data Manager positions in Mexico, Argentina, and/or Brazil.
Job Purpose:

The Clinical Data Manager will be responsible for performing Data Management activities that support the sponsor’s commercial and development projects worldwide.He/she will participate as an activememberofamulti-disciplinaryteamtoplanand executetheDataManagementtasksrequiredfor phase 1-4 studies. The Clinical Data Manager has a broad, fundamental knowledge of the data management process and is able to perform most required tasks with moderate guidance

Key Accountabilities:

- Be able to lead a small clinical study or co-lead a larger study or studies with moderate guidance

- Be able to support several clinical studies with minimal guidance

- Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies

- Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.

- Be able to perform a thoroughly detailed review of eCRF data requirements.

- Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.

- Develop data edit check specifications and run data listings as required

- Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members

- Develop the Data Management Plan for a clinical study.

- Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications

- Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries

- Perform reconciliation of header data from external data sources against the clinical database

- Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines

- Assist in database upgrades/migrations including performing User Acceptance Testing

- Able to maintain study workbooks and data management files

- Perform database lock and freeze activities per company SOPs

- Participate in regular team meetings and provide input when appropriate

- Provide input into the development of data management SOPs, Work Instructions, and process documents

- Contribute to a professional working environment including the application of the client’s Code of Business Conduct and Ethics

- Assist with the training of new employees and/or contractors

- Collaborative relationships

- Collaborates with cross-functional teams to design and implement effective data collection strategies, ensuring high-quality data capture and timely resolution of data queries throughout the clinical trial lifecycle.

- Compliance with Parexel standards

- Complies with required training curriculum

- Completes timesheets accurately as required

- Submits expense reports as required

- Updates CV as required

- Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Knowledge and Experience:

- 5+ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment

- Understands the scope and focus of Phase 1-4 clinical studies, and has a proven ability to perform some of the core Data Management tas