# FSP Lead Data Manager

**Company**: Fortrea
**Location**: Beijing or Shanghai
**Experience**: senior
**Job type**: full-time
**Category**: Data Science
**Industry**: Healthcare

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Beijing/Senior-Clinical-Data-Manager_266015?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_68b9c341-580

## Description

Fortrea is currently recruiting for an FSP Lead Data Manager for a global pharmaceutical project. This position can be based in either Beijing or Shanghai.

**Key Responsibilities**

- Provide very strong subject matter expertise in the Data Management (DM) discipline, supporting multiple studies concurrently with minimal oversight.

- Advocate the DM position on technical processes within study team meetings and share DM process knowledge with study team colleagues and cross-functional peers.

- Oversee multiple DM vendors, provide training, and subject matter expertise to lower-level DM peers.

- Lead by example, providing data management expertise and input into drug development programs.

- Act as a functional DM expert for specific DM specialty areas, such as data standards, Medical Coding, eSource, external data, data visualization, and analytics.

- Review Key Risk Indicators (KRIs) outputs in aggregate across sites, regions, and countries, and investigate observations as needed.

- Support the team in assessing centralized monitoring observations to identify potential issues and risks during study conduct.

- Perform vendor oversight activities across multiple studies, reviewing and providing input on vendor oversight processes.

- Document process-related deviations and communicate to the functional manager, taking immediate action if concerns arise regarding the quality of DM deliverables.

- Demonstrate expert cross-functional understanding of the impact of data management processes on other stakeholders.

- Lead data review meetings for all data sources with Medical, Clinical Operations, Biostatistics, and Programming to highlight and discuss deviations from the protocol and specific data values.

- Understand regulatory requirements, such as GCP, and their impact on Data Management activities and outputs.

**Required Qualifications**

- Bachelor's degree in a biological science, health-related, or computer science field (or equivalent experience).

- Typically 8+ years of relevant experience in the pharmaceutical, clinical research, or health services industry, including at least 6 years as a Data Manager with progressive leadership responsibility.

- Demonstrated expertise in Data Management from program inception through regulatory submission (regulatory submissions experience preferred).

- Recognized leadership and subject matter expertise in Data Management-related global process improvement initiatives.

- Extensive experience with external data management and digital health solutions (e.g., eSource, eCOA, eConsent), including edata processes, central monitoring tools, and risk-based quality management (RBQM) principles.

- Advanced understanding of clinical data standards (e.g., CDISC) and ability to apply standards across studies and programs.

- Strong computer skills, including database management software, reporting tools, and medical coding systems.

- In-depth knowledge of different data sources in clinical trial settings and associated data quality considerations.

- Prior inspection and audit experience.

- Proven project management and organizational skills to prioritize and direct work for self and others to meet timelines.

- Ability to influence and guide study teams, driving decision-making and issue resolution across functions and vendors.

- Demonstrated critical thinking and sound judgment in complex or ambiguous data management scenarios.

- Demonstrated learning agility and ability to drive adoption of new technologies and capabilities for Data Management.

**Preferred Qualifications**

- SCDM Certified Clinical Data Manager.

- Experience with RAVE, eClinical Solutions elluminate, and CluePoints is a plus.

## Skills

### Required
- Data Management
- clinical data standards
- CDISC
- database management software
- reporting tools
- medical coding systems
- eSource
- eCOA
- eConsent
- central monitoring tools
- risk-based quality management
- RBQM
- project management
- organizational skills
- critical thinking
- sound judgement

### Nice to have
- SCDM Certified Clinical Data Manager
- RAVE
- eClinical Solutions elluminate
- CluePoints

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Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Beijing/Senior-Clinical-Data-Manager_266015?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)