Project Data Manager

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

📋 Description

• Serve as the Functional Lead for Data Management, acting as the main internal point of contact between Data Management/Operations, Project Management, Clinical Monitoring, and other functional teams.

• Oversee the designated Data Management/Data Operations team.

• Ensure the initiation, execution, and completion of Data Management tasks and milestones are in line with contractual obligations, Standard Operating Procedures (SOPs), guidelines, and regulations.

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

• Manage project finances, including revenue recognition and scope adjustments; engage in internal project review meetings and collaborate with Finance and Contracts departments.

• Track and communicate project advancements to the Sponsor and project team through status reports, tracking tools, and metrics.

• Plan, oversee, and requisition resources for the assigned projects.

• Create and maintain project plans, specifications, and documentation.

• Keep ongoing documentation updated and ensure Trial Master File (TMF) filing is accurate and current.

• Take part in and present at internal meetings, Sponsor meetings, third-party consultations, and investigator gatherings.

• Prepare documentation and participate in both internal and external audits.

• Mentor and train data management personnel.

• Contribute to and take part in proposal bid defense meetings.

• Maintain expertise in Data Management systems and processes through continuous training.

• Carry out other related responsibilities as assigned.

⛳️ Requirements

• Bachelor’s degree in biological sciences or related fields in the natural science/healthcare area; equivalent relevant work experience may be accepted in lieu of a degree.

• Experience in clinical data management or a comparable combination of education and experience.

• Familiarity with Clinical Data Management practices and relational database management software systems.

• Strong project management capabilities and knowledge of project management methodologies.

• Proven leadership skills in staff management.

• Experience in a Contract Research Organization (CRO) is preferred.

• Direct experience with Oracle Clinical, Rave, or Inform systems.

• Understanding of medical terminology, clinical data, and ICH/Good Clinical Practices.

• Proficient in MS Windows navigation, as well as Word, Excel, PowerPoint, and email applications.

• Strong oral and written communication abilities.

• Excellent presentation skills.

• Good organizational, planning, and time management skills; ability to multitask under tight deadlines while maintaining attention to detail.

• Flexibility and adaptability to change, with the ability to work independently and as part of a multidisciplinary team.

• Capable of making effective decisions and managing multiple priorities in a fast-paced environment.

• Minimal travel may be necessary (up to 25%).

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition.

• Comprehensive total rewards program.

• An inclusive culture.

• Extensive resources, including emerging technologies, data, science, and knowledge sharing.

• Flexible work arrangements: Remote (Pre-Approved).