Note: The job is a remote job and is open to candidates in USA. CIMS Global is seeking a Project Manager for Clinical Data Services to oversee clinical data service projects from study startup through regulatory submission. The role involves coordinating cross-functional activities, managing client communications, and ensuring projects are delivered on time and within budget.
Responsibilities
- Lead cross-functional clinical data service projects throughout the study lifecycle
- Develop and maintain comprehensive project plans, timelines, milestones, and deliverables
- Coordinate study startup, execution, database lock, statistical analysis, and submission activities
- Ensure project objectives, timelines, budgets, and quality expectations are achieved
- Manage multiple concurrent projects of varying complexity
- Serve as the primary point of contact for sponsors
- Organize and lead project kickoff meetings, routine status meetings, and governance meetings
- Prepare meeting agendas, meeting minutes, and action item trackers
- Build strong client relationships through proactive communication and issue resolution
- Provide regular project status updates and executive summaries
- Coordinate activities across: Clinical Data Management, Biostatistics, Statistical Programming (SAS/R), Medical Writing, Clinical Data Standards (CDISC), Database Build and Validation, Medical Coding, Data Review and Cleaning, Regulatory Submission Support, DMC Operations (when applicable)
- Ensure effective collaboration among internal teams and external vendors
- Develop project schedules and resource plans
- Track deliverables against agreed timelines
- Monitor project progress using project management tools
- Identify schedule risks and implement mitigation plans
- Manage project changes and scope modifications
- Track project budgets and resource utilization
- Review change orders and out-of-scope requests
- Support proposal development and project forecasting
- Assist with invoice review and milestone tracking
- Identify operational and technical risks early
- Maintain project risk logs and mitigation plans
- Escalate critical issues appropriately
- Facilitate resolution of cross-functional issues
- Ensure compliance with company SOPs, GCP, ICH guidelines, and applicable regulatory requirements
- Coordinate quality review activities
- Ensure project documentation is complete and inspection-ready
- Coordinate resource assignments with department managers
- Monitor workload and utilization
- Support project staffing decisions
- Assist with onboarding project team members
- Maintain project documentation, including: Project plans, Communication plans, Risk registers, Decision logs, Action item trackers, Meeting minutes, Status reports, Change requests
Skills
- Bachelor's degree in life sciences, health sciences, information technology, or related field
- Minimum of 3 years of relevant experience in a similar role in clinical research, a CRO, or the pharmaceutical/biotechnology industry
- Experience managing biometrics or clinical data service projects
- Strong understanding of clinical trial processes from startup through regulatory submission
- Experience working directly with sponsors
- Clinical trial operations
- Clinical Data Management
- Biostatistics, Statistical Programming workflows
- CDISC standards (SDTM, ADaM)
- EDC systems
- ICH-GCP, FDA and EMA regulatory expectations
- MSc in life science, medicine, or related field is a plus
- PMP certification is preferred
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