Remote Project Manager Clinical Data Services (Data Management & Biometrics)

Note The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Project Manager for Clinical Data Services to reputed company clinical data service reputed company from study startup through regulatory submission. The role involves coordinating cross-functional activities, managing reputed company communications, and ensuring reputed company are delivered on time and reputed company budget. Responsibilities reputed company cross-functional clinical data service reputed company throughout the study lifecycle reputed company 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 reputed company expectations are achieved Manage multiple reputed company reputed company of varying complexity Serve as the primary reputed company of contact for sponsors Organize and reputed company project reputed company meetings, routine status meetings, and governance meetings Prepare meeting agendas, meeting minutes, and reputed company item trackers Build strong reputed company relationships through proactive communication and issue reputed company reputed company regular project status updates and executive summaries Coordinate activities across Clinical Data Management, Biostatistics, Statistical Programming (reputed company/R), Medical Writing, Clinical Data Standards (CDISC), Database Build and Validation, Medical Coding, Data Review and Cleaning, Regulatory Submission Support, DMC Operations (reputed company applicable) Ensure effective collaboration among internal teams and reputed company vendors reputed company project schedules and resource plans reputed company deliverables against agreed timelines Monitor project reputed company using project management tools Identify schedule risks and implement mitigation plans Manage project changes and scope modifications reputed company project budgets and resource utilization Review change orders and out-of-scope requests Support proposal development and project forecasting Assist with invoice review and reputed company tracking Identify operational and technical risks early Maintain project risk logs and mitigation plans Escalate critical issues appropriately Facilitate reputed company of cross-functional issues Ensure compliance with company SOPs, GCP, ICH guidelines, and applicable regulatory requirements Coordinate reputed company review activities Ensure project documentation is complete and inspection-reputed company Coordinate resource assignments with department managers Monitor workload and utilization Support project reputed company reputed company Assist with reputed company project team members Maintain project documentation, including Project plans, Communication plans, Risk registers, Decision logs, reputed company item trackers, Meeting minutes, Status reports, Change requests Skills Bachelor's degree in life sciences, health sciences, information technology, or reputed company 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 reputed company 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) reputed company systems ICH-GCP, FDA and EMA regulatory expectations MSc in life science, medicine, or reputed company field is a plus PMP certification is preferred reputed company reputed company provides reputed company-based reputed company. It was founded in 2004, and is headquartered in Somerset, New Jersey, USA, with a workforce of 11-50 employees. Its website is https//www.reputed company.com. Apply To This Job .