Project Data Manager – Sponsor Dedicated

📋 Description

• Serves as the Functional Lead for Data Management, acting as the primary liaison between Data Management/Operations and Project Management, Clinical Monitoring, and other functional teams.

• Oversees the activities of the designated Data Management/Data Operations team.

• Guarantees the launch, delivery, and completion of all Data Management tasks and milestones in accordance with contractual agreements and applicable Standard Operating Procedures (SOPs), guidelines, and regulations.

• Delivers project-specific training to both internal and external stakeholders as necessary.

• Manages the financial aspects of assigned projects/programs, including revenue recognition, scope changes, and participation in internal project review meetings, liaising with Finance and Contracts teams when required.

• Tracks and reports project progress to the Sponsor and project team, utilizing project status reports and tracking tools/metrics to facilitate real-time data collection and query management.

• Plans, manages, and requests resources for the projects assigned.

• Develops and maintains project plans, specifications, and documentation in compliance with SOP requirements.

• Continuously maintains documentation and ensures that all Trial Master File (TMF) records are complete and current.

• Engages in and presents at internal, Sponsor, third-party, and investigator meetings.

• Prepares necessary documentation to support internal and external audits and participates in these audits.

• Trains and mentors staff within data management.

• Provides input for, and participates in, proposal bid defense meetings.

• Maintains expertise in Data Management systems and processes through regular training.

• Undertakes other work-related duties as assigned.

⛳️ Requirements

• BA/BS in biological sciences or related fields within the natural science/health care sector, or a Registered Nurse.

• Alternatively, equivalent relevant work experience may be considered in place 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 abilities.

• Experience with Contract Research Organizations (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 navigating MS Windows, Word, Excel, PowerPoint, and email applications.

• Excellent oral and written communication skills.

• Strong presentation abilities.

• Effective organizational, planning, and time management skills with the capability to multitask under tight deadlines while maintaining attention to detail.

• Ability to be flexible and adapt to change, working independently as well as part of a multidisciplinary team.

• Capacity to make sound decisions and manage multiple priorities in a fast-paced environment.

🏝️ Benefits

• We are dedicated to fostering our employees' development through career advancement opportunities;

• Supportive and engaged direct management;

• Training in technical and therapeutic areas;

• Peer recognition and a comprehensive rewards program.

• Committed to cultivating an inclusive culture where you can truly be yourself.