Project Data Manager

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

📋 Description

• Oversee all data management services for designated projects.

• Act as the Functional Lead for Data Management and the primary point of contact among Data Management/Operations, Project Management, Clinical Monitoring, and other functional departments.

• Coordinate the assigned Data Management/Data Operations teams.

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

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

• Manage project finances, including revenue recognition, adjustments in scope, and internal project evaluations.

• Monitor and convey project progress to sponsors and project teams through status reports, tracking tools, and metrics.

• Plan, oversee, and request resources for the project.

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

• Maintain ongoing documentation and ensure complete and up-to-date TMF filing.

• Participate in and present at internal, sponsor, third-party, and investigator meetings.

• Prepare documentation for and engage in internal and external audits.

• Train and mentor data management personnel.

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

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

• Perform additional related duties as assigned; minimal travel may be required, up to 25%.

⛳️ Requirements

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

• Over 10 years of experience in Clinical Data Management.

• Proven experience in leading studies and interacting with clients.

• Comprehensive end-to-end CDM experience, including setup, execution, and closeout.

• Familiarity with Rave CDMS.

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

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

• Proven leadership abilities with staff.

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

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

• Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications.

• Strong oral and written communication skills.

• Competent presentation abilities.

• Excellent organizational, planning, and time management skills; ability to multitask under tight deadlines with attention to detail.

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

• Capability to make sound decisions and manage multiple priorities in a highly dynamic environment.

• Experience in the oncology therapeutic area is preferred.

• Experience in Phase 1 and clinical pharmacology is preferred.

• Previous experience with a Contract Research Organization (CRO) is preferred.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition.

• Comprehensive total rewards program.

• An inclusive culture.