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Bengaluru, Karnataka, India
Onsite
This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Project Data Manager (ClinSpark) based in India.
The Senior Project Data Manager (ClinSpark) will lead clinical data management activities across assigned clinical research projects, ensuring high-quality delivery aligned with contractual commitments, regulatory requirements, and sponsor expectations. This role combines project leadership, technical expertise, resource coordination, and stakeholder management in a dynamic, global clinical research environment. You will oversee data management workflows from project initiation through completion, monitor milestones and performance, and ensure accurate documentation and reporting. Working closely with sponsors and multidisciplinary teams, you will help optimize processes, improve data workflows, and support the integrity of clinical trial data. You will also mentor team members, contribute to audits and proposals, and drive operational excellence across complex projects.
Lead clinical data management activities for assigned projects, serving as the primary sponsor contact for data management deliverables or as the functional lead within full-service projects.
Coordinate data management and data operations teams to ensure timely, accurate delivery of project milestones in accordance with contracts, SOPs, guidelines, and applicable regulations.
Develop and maintain project plans, specifications, workflows, and documentation, ensuring ongoing maintenance of trial documentation and the Trial Master File (TMF).
Monitor project progress, data collection, query management, and performance metrics, providing regular status updates to sponsors and internal stakeholders.
Manage project finances, including revenue recognition and scope changes, and collaborate with finance and contracts teams as needed.
Plan and request project resources, support resource management, and deliver project-specific training to internal and external stakeholders.
Prepare documentation for internal and external audits, 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.
Maintain expertise in data management systems and processes, participate in relevant professional development activities, and undertake occasional travel of up to 25%.
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.
Strong project management capabilities, including planning, resource coordination, prioritization, and delivery within demanding timelines.
Experience with Oracle Clinical, Rave, or Inform is desirable, alongside knowledge of medical terminology, clinical data, and ICH/Good Clinical Practice (GCP) requirements.
Contract Research Organization (CRO) experience is preferred.
Proficiency in Microsoft Windows, Word, Excel, PowerPoint, and email applications.
Excellent written and verbal communication, presentation, organizational, planning, and time-management skills, with strong attention to detail.
Demonstrated leadership and mentoring abilities, adaptability, independent judgment, and the ability to collaborate effectively across multidisciplinary teams in a changing environment.
Opportunities for professional development, career progression, and ongoing technical and therapeutic-area training.
Supportive line management and peer recognition.
Access to a collaborative, multidisciplinary environment working on clinical research and healthcare initiatives with global impact.
Exposure to emerging technologies, scientific expertise, and knowledge-sharing opportunities.
Opportunities to develop expertise and pursue diverse career paths within a global clinical research environment.
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