Project Data Manager

Posted 4 days ago

This is a fully remote position, open to applicants in China.

📋 Description

• Serve as the Functional Lead for Data Management.

• Act as the primary internal contact between Data Management/Operations, Project Management, Clinical Monitoring, and other departments.

• Oversee the assigned Data Management/Data Operations team.

• Guarantee the launch, delivery, and completion of Data Management activities and milestones in accordance with contractual agreements, SOPs, guidelines, and regulations.

• Provide project-specific training to both internal and external stakeholders.

• Track and communicate project progress, including project status updates and metrics for in-stream data collection and query management.

• Plan, manage, and request resources for designated projects.

• Create and maintain project plans, specifications, and documentation in accordance with SOP requirements.

• Ensure documentation is current and all TMF filing is complete.

• Engage in and present at internal, Sponsor, third-party, and investigator meetings.

• Prepare for and develop documentation supporting internal and external audits; participate in audits.


⛳️ Requirements

• Equivalent experience, skills, and/or education will be taken into account.

• Ability to coordinate Data Management/Data Operations teams effectively.

• Familiarity with Standard Operating Procedures (SOPs), guidelines, and regulations.

• Capability to monitor project progress using status reports, tracking tools, and metrics.

• Competence in planning, managing, and requesting project resources.

• Proficiency in developing and maintaining project plans, specifications, and documentation.

• Expertise in maintaining Trial Master File (TMF) documentation and filing.

• Ability to prepare documentation for and actively participate in internal and external audits.


🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in both technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Reasonable accommodations when suitable for employees or applicants with disabilities.

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