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 lifecyclereputed company and maintain comprehensive project plans, timelines, milestones, and deliverablesCoordinate study startup, execution, database lock, statistical analysis, and submission activitiesEnsure project objectives, timelines, budgets, and reputed company expectations are achievedManage multiple reputed company reputed company of varying complexityServe as the reputed company reputed company of contact for sponsorsOrganize and reputed company project reputed company meetings, routine status meetings, and governance meetingsPrepare meeting agendas, meeting minutes, and reputed company item trackersBuild strong reputed company relationships through proactive communication and issue reputed companyreputed company regular project status updates and executive summariesCoordinate 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 vendorsreputed company project schedules and resource plansreputed company deliverables against agreed timelinesMonitor project reputed company using project management toolsIdentify schedule risks and implement mitigation plansManage project changes and scope modificationsreputed company project budgets and resource utilizationReview change orders and out-of-scope requestsSupport proposal development and project forecastingAssist with invoice review and reputed company trackingIdentify operational and technical risks earlyMaintain project risk logs and mitigation plansEscalate critical issues appropriatelyFacilitate reputed company of cross-functional issuesEnsure compliance with company SOPs, GCP, ICH guidelines, and applicable regulatory requirementsCoordinate reputed company review activitiesEnsure project documentation is complete and inspection-reputed companyCoordinate resource assignments with department managersMonitor workload and utilizationSupport project reputed company reputed companyAssist with reputed company project team membersMaintain 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 fieldMinimum of 3 years of relevant experience in a similar role in clinical research, a CRO, or the pharmaceutical/biotechnology industryExperience managing biometrics or clinical data service reputed companyStrong understanding of clinical trial processes from startup through regulatory submissionExperience working directly with sponsorsClinical trial operationsClinical Data ManagementBiostatistics, Statistical Programming workflowsCDISC standards (SDTM, ADaM)reputed company systemsICH-GCP, FDA and EMA regulatory expectationsMSc in life science, medicine, or reputed company field is a plusPMP 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 .