Project Manager (Germany)
Core
Ensures successful initiation, planning, execution, monitoring, controlling, and closure of clinical research projects, ensuring compliance with budget, scope, timelines, SOPs, GCP, and regulatory requirements.
Role type
Junior Project Manager (Clinical Research) (via careerplan.io/jobs/15-003-AC-A68-project-manager-germany-at-indero)
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 management planning, Resource allocation, Site selection and qualification, Patient recruitment monitoring, Vendor coordination, Data management compliance, Regulatory submission support
Preferred skills
French language proficiency, Experience in matrix environments, Training and process improvement expertise
Technologies
Microsoft Office suite, Electronic Case Report Forms (eCRF), Trial Master File (TMF)
Responsibilities
Coordinate tasks and deadlines between departments; Oversee project coordinators and team members; Interact with vendor management for site activation; Escalate site activation risks; Manage project status updates; Reconcile study trackers; Analyze discrepancies and implement corrective actions; Enforce change control and risk management; Review and draft project operational plans; Ensure study documents meet country requirements; Oversee site selection and qualification; Monitor patient recruitment; Participate in Investigator's Meetings; Oversee ethics and regulatory submissions; Support clinical monitoring activities; Track site visits and compliance; Maintain training matrices; Support sites with study materials; Ensure CRF compliance and query resolution.
Seniority
Junior, hands-on IC