Clinical Project Manager

Reference: 632446Posted: 2026-11-12Location: New York, New YorkCompany: Planet Pharma GroupContact: ApplicationsEmail: View email address on click.appcast.io of JobContribute to the execution of gene therapy and associated projects per development plan, from planning and initiation through to closeout. Ensure that all clinical study management and project deliverables are completed on time, within budget, to high quality and in accordance with SOPs, policies and practices.Major ActivitiesLead day-to-day operational execution of assigned clinical trials from study start up through study completionAccountable for ensuring that clinical trial is executed on time, with high-quality data and in compliance with the protocol, ICH-GCP, applicable regulations and company procedures. Lead activities related to clinical trial start up, including site identification, feasibility, selection, contracting, budgeting, coordination of regulatory and IRB/IEC submissions, essential document collection, and site activation Direct and oversee service provider contracts, and investigator site clinical trial agreement negotiationsResponsible for study budget compliance and partner with key stakeholders to support financial requirements.Direct and oversee site and team communicationsDevelop and maintain project management plans and critical path activitiesLeads the cross-functional Study Team meetings and responsible for ensuring timely follow up and resolution of action items.Liaise with all internal stakeholders and external service providers to ensure data is reported accurately and in a timely manner Serve as primary operational point of contact for outsourced clinical service provider management and oversight of vendor performance, deliverables, timelines and quality.Accountable for oversight of TMF set-up and maintenance, ensuring inspection readinessCollaborate internally and externally to ensure clinical milestones are achieved and to ensure issues and obstacles are managed accordingly.Escalate significant performance, quality, timelines or other concerns to Clincal Operations leadershipManage risk by proactive risk identification, implementation of mitigation strategies and contingency plansSupervise the implementation of corrective and preventative action plans (CAPAs)Contribute to development of study documentation (protocols, IB, ICF, etc)Review trial data and procedures ensuring good quality dataEstablish and maintain good communication and relationships with external stakeholders including investigators, Key Opinion Leaders, Contract Research Organisations, and external consultantsContribute to the development of the clinical quality management system through the development and review of Standard Operating Procedures and supporting documentsProvide assistance and participate in audits and inspectionsKey Job CompetenciesDetailed understanding of clinical trial processes and regulations, in particular within the USA, UK and EUKnowledge of ICH GCPIT literacy, particularly in Word, Excel, PowerpointExperience in use of eTMF (Veeva Vault experience preferred) Understanding of GDPR and general data privacy guidelinesAdditional ResponsibilitiesRole will include some line management of Clinical Trial Managers and/or Clinical Trial AdministratorsCandidate BackgroundIdeally educated to undergraduate degree level (or equivalent) in a Biological Science discipline or related field5+ years of clinical trial management experience, ideally including trials of an advanced therapy medicinal product (ATIMP) and managing Phase 1-3 clinical trials in a biotech or pharmaceutical environmentStrong experience in managing clinical trials from start up through closeout. Including leading and directing CROs, clinical sites and external vendorsStrong understanding of ICH-GCP and applicable clinical research regulations