Project Manager (Germany)
Core
Ensures successful initiation, planning, execution, monitoring, controlling, and closure of clinical research projects while ensuring compliance with budget, scope, timelines, SOPs, GCP, and regulatory requirements.
Role type
Junior Project Manager (Clinical Research)
Builds
Clinical trial studies for pharmaceutical, biotechnology, and CRO clients
Domain
Clinical Research / Pharmaceutical / Biotechnology
Required skills
Clinical trial management, GCP and ICH standards knowledge, FDA and Canadian regulations knowledge, Microsoft Office suite, project planning, resource management, site selection and qualification, patient recruitment monitoring, data management compliance, vendor coordination, risk management, change control, training matrix maintenance, essential document collection, TMF quality review support, clinical monitoring support, Investigator's Meeting planning, regulatory submission support, site initiation and close-out visit tracking, study supply management, protocol and eCRF compliance, query resolution, corrective action development, process improvement. (via careerplan.io/jobs/15-003-AC-A68-project-manager-germany)
Preferred skills
French language proficiency, experience in dermatology research, matrix environment management, technical therapeutic expertise.
Responsibilities
Serve as primary contact for Sponsor, vendors, and internal teams; coordinate tasks and deadlines across departments; oversee project coordinators and team members for site activation; interact with vendor management for supply and service coordination; escalate site activation risks; manage stakeholder expectations; ensure team training; plan activities and resources; manage work quality and deliverables; provide project status updates; reconcile study trackers; analyze discrepancies and implement corrective actions; enforce change control and risk management; draft project operational plans and manuals; ensure study documents meet country requirements; oversee site selection and qualification; monitor patient recruitment and subject status; participate in Investigator's Meetings; oversee ethics and regulatory submissions; ensure collection of essential site documents; assist with TMF quality reviews and audits; support clinical monitoring activities; track site visits and compliance; maintain training matrix; support sites with study materials; ensure CRF compliance and query resolution; provide training and process improvement expertise.
Seniority
Junior, hands-on IC