Senior Project Data Manager (ClinSpark)
New
J
JobgetherClinical research
Based in IndiaFull-TimeSenior
Salary not disclosed
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Job Details
- Required Skills
- Microsoft Excel
Requirements
- Bachelor’s degree in biological sciences, natural sciences, healthcare, or a related discipline, or Registered Nurse qualification; equivalent relevant professional experience may be considered.
- Demonstrated experience in clinical data management, including clinical data management practices and relational database management systems.
- Technical knowledge of electronic data capture (EDC) programming, Rave web services, data integration, and data mapping activities.
- Familiarity with CDISC standards, including CDASH, SDTM, ODM-XML, and Pinnacle 21, as well as eSource data and eSource capture systems.
- Experience designing and implementing data workflows, developing processes and tools, and evaluating and optimizing operational processes.
- Project management capabilities, including planning, resource coordination, prioritization, and delivery within demanding timelines.
- Knowledge of medical terminology, clinical data, and ICH/Good Clinical Practice (GCP) requirements.
- Proficiency in Microsoft Windows, Word, Excel, PowerPoint, and email applications.
- Demonstrated leadership and mentoring abilities, adaptability, independent judgment, and ability to collaborate across multidisciplinary teams.
- Willingness to undertake occasional travel of up to 25%.
Responsibilities
- Lead clinical data management activities for assigned projects and serve as the primary sponsor contact for data management deliverables or functional lead within full-service projects.
- Coordinate data management and data operations teams to deliver project milestones in accordance with contracts, SOPs, guidelines, and applicable regulations.
- Develop and maintain project plans, specifications, workflows, and trial documentation, including the Trial Master File.
- Monitor project progress, data collection, query management, and performance metrics, and provide status updates to sponsors and internal stakeholders.
- Manage project finances, including revenue recognition and scope changes, in collaboration with finance and contracts teams.
- Plan and request project resources, support resource management, and deliver project-specific training.
- Prepare audit documentation, participate in audit activities, and represent data management in sponsor, investigator, third-party, and internal meetings.
- Train and mentor data management staff, provide subject matter expertise, and contribute to proposals and bid defense meetings.
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