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.