Project Data Manager

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

📋 Description

• Serve as the Functional Lead for Data Management and act as the primary internal contact with Data Management/Operations, Project Management, Clinical Monitoring, and other functional teams.

• Oversee the assigned Data Management/Data Operations team.

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

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

• Manage project finances, which include revenue recognition, changes in scope, and internal project reviews, coordinating with Finance and Contracts as necessary.

• Track and report project progress to the Sponsor and project team using status reports and tracking tools/metrics.

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

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

• Keep ongoing documentation up-to-date and ensure that TMF filing is complete and current.

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

• Create documentation for and participate in both internal and external audits.

• Mentor and train data management staff.

• Prepare contributions for and take part in proposal bid defense meetings.

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

• Carry out other related duties as assigned.

⛳️ Requirements

• BA/BS in biological sciences or related fields in the natural sciences/health care sector, or a Registered Nurse; relevant work experience may be accepted in place of a degree.

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

• Familiarity with clinical data management practices and relational database management software systems.

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

• Proven leadership skills in managing staff.

• 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.

• Proficiency in navigating MS Windows, as well as using Word, Excel, PowerPoint, and email applications.

• Strong oral and written communication skills.

• Excellent presentation capabilities.

• Good skills in organization, planning, and time management.

• Ability to multitask under tight deadlines while paying attention to detail.

• Flexibility and adaptability to change.

• Capacity to work independently and collaboratively within a multi-disciplinary team.

• Aptitude for making effective decisions and managing multiple priorities in a dynamic environment.

🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• An inclusive culture.

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