Project Data Manager
Position Overview
As a Project Data Manager at Syneos Health, you will lead and oversee all aspects of data management for clinical trials, acting as the primary liaison between internal teams and external stakeholders. This role ensures the successful planning, execution, and delivery of high-quality clinical data to meet regulatory and contractual obligations.
Key Responsibilities
Functional Leadership:
Serve as the primary point of contact for Data Management (DM) activities.
Coordinate and manage the assigned DM/Operations team to deliver project milestones.
Project Execution:
Ensure timely delivery of DM activities in alignment with contractual agreements, SOPs, and regulatory requirements.
Develop, implement, and maintain project plans, specifications, and documentation.
Provide project-specific training for internal and external teams.
Communication & Progress Monitoring:
Regularly monitor and communicate project progress using status reports and tracking tools.
Maintain transparent communication with sponsors, stakeholders, and project teams.
Resource Management:
Plan, manage, and allocate resources effectively to meet project requirements.
Quality Assurance & Documentation:
Ensure all DM documentation and Trial Master File (TMF) records are complete and up to date.
Prepare for and participate in audits and inspections.
Training & Mentorship:
Train and mentor junior DM staff, promoting knowledge-sharing and skill development.
Proposal Support:
Contribute to proposal development and participate in bid defense meetings as needed.
Technology Proficiency:
Maintain expertise in DM systems and processes, including Oracle Clinical, Rave, or Inform.
Qualifications
Education:
Bachelor’s or Master’s degree in biological sciences, health care, or a related field.
Equivalent work experience may be considered in lieu of a formal degree.
Experience:
Proven experience in clinical data management within a CRO or pharmaceutical setting.
Strong familiarity with DM practices, relational database systems, and regulatory guidelines (ICH/GCP).
Technical Skills:
Proficiency in Oracle Clinical, Rave, or Inform systems.
Advanced knowledge of MS Office applications (Word, Excel, PowerPoint).
Understanding of medical terminology and clinical data.
Project Management:
Expertise in project management methodologies with demonstrated leadership skills.
Strong organizational, planning, and time-management abilities to handle tight deadlines.
Soft Skills:
Excellent oral and written communication skills.
Strong presentation and interpersonal skills.
Adaptable, detail-oriented, and capable of making effective decisions in dynamic environments.
Why Join Syneos Health?
Impactful Work: Be part of a team contributing to 94% of novel FDA-approved drugs over the past 5 years.
Growth Opportunities: Access career development programs, technical training, and mentorship.
Diverse & Inclusive Culture: Join a company that values diversity and promotes a Total Self Culture, ensuring everyone feels they belong.
Work Flexibility: Enjoy a home-based role with minimal travel requirements (up to 25%).
Location: India (Home-Based)
Updated: December 3, 2024
Job ID: 24006310
Apply Now to advance your career in clinical data management while making a meaningful impact on patient lives globally.
Gujarat :
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