Clinical Trial Manager – Contract

Jobtailor; Deutschland; Remote; EUR 90.000 - 135.000; Vollzeit

Benefits dieser Stelle

Health insurance

Travel opportunities

Zusammenfassung

Jobtailor in Germany seeks a seasoned Clinical Operations Manager to lead day-to-day conduct of Phase 1-3 trials, ensure GCP compliance, and manage start-up, conduct, and close-out activities.

You will coordinate CROs and service providers, track milestones and timelines, prepare trial documents, maintain the Trial Master File, manage budgets, and travel to sites and conferences as needed.

Strong collaboration with the legal and therapeutic teams is essential.

Qualifikationen

• 6+ years of clinical research experience within Biotech or similar industry.
• At least 2 years directly supporting a retina clinical trial.
• GCP, ICH guidelines, and regulatory requirements for clinical trial management.
• Regulatory framework knowledge for interactions with HCPs, payers, advocacy, and partners.
• Clinical operational skills to direct protocol execution and meet timelines, budget, and quality metrics.
• Experience reviewing trial plans including site monitoring, risk mitigation, budgets, site selection, and clinical supplies management.
• Strong clinical research knowledge with cross-functional understanding of trial methodology.
• Proficient in Microsoft Office Suite; working knowledge of MS Project.

Aufgaben

• Support the Company's clinical trial activities and report to the Director of Clinical Operations.
• Manage day-to-day operations of Phase 1-3 trials, including start-up, conduct, and close-out.
• Serve as primary contact for protocol execution and oversee CROs, service providers, and consultants.
• Lead cross-functional study execution teams and track study milestones, metrics, and timelines.
• Ensure trials comply with ICH GCP, regulations, protocols, and SOPs.
• Prepare and review trial documentation, including protocols, informed consent forms, investigator brochures, monitoring plans, project plans, CRFs, SAPs, and clinical study reports.
• Establish and maintain the Trial Master File and support audit readiness and resolution of audit findings.
• Participate in service-provider selection and support issue resolution and process improvement.
• Assess operational feasibility, recommend study execution plans and site selection, and train CRO staff, monitors, sites, and service providers.
• Facilitate clinical trial agreements with the legal group.
• Manage budgets, financial reporting, projections, site contracts, and invoices.
• Perform ongoing data review and site visits, including qualification, initiation, monitoring, and close-out.
• Oversee outsourced monitoring, protocol deviation tracking, clinical supplies forecasting, and site issue resolution.
• May manage junior Clinical Operations staff and support Clinical SOP development.
• Travel to sites, conferences, and industry meetings as needed.

Kenntnisse

Clinical Trial Management

GCP Compliance

Protocol Execution

Budget Management

Cross-Functional Team Leadership

Site Monitoring

Data Review

Trial Master File Management

Regulatory Requirements Knowledge

Retina Clinical Trial Support

Ausbildung

B.A./B.S. degree in Science

Tools

MS Project

Microsoft Office Suite

Jobbeschreibung

• Support the Company's clinical trial activities and report to the Director of Clinical Operations
• Manage day-to-day operations of one or more Phase 1-3 clinical trials, including start-up, conduct, and close-out
• Serve as primary contact for protocol execution and oversee CROs, service providers, and consultants
• Lead cross-functional study execution teams and track study milestones, metrics, and timelines
• Ensure trials comply with ICH GCP, regulations, protocols, and company SOPs
• Prepare and review clinical trial documentation, including protocols, informed consent forms, investigator brochures, monitoring plans, project plans, CRFs, SAPs, and clinical study reports
• Establish and maintain the Trial Master File and support audit readiness and resolution of audit findings
• Participate in service-provider selection and support issue resolution and process improvement
• Assess operational feasibility, recommend study execution plans and site selection, and train CRO staff, monitors, sites, and service providers
• Facilitate clinical trial agreements with the legal group
• Manage clinical trial budgets, financial reporting, projections, site contracts, and invoices
• Perform ongoing data review and site visits, including qualification, initiation, monitoring, and close-out
• Oversee outsourced monitoring, protocol deviation tracking, clinical supplies forecasting, and site issue resolution
• May manage junior Clinical Operations staff and support Clinical SOP development
• Travel to sites, conferences, and industry meetings as needed

Requirements

• B.A./B.S. degree in Science
• 6+ years of clinical research experience within the Biotech or similar industry
• At least 2 years directly supporting a retina clinical trial
• Knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trial management
• Understanding of regulatory framework applicable to interactions with HCPs, payers, advocacy, and other business partners
• Proven clinical operational skills to direct protocol execution and meet timeline, budget, and quality metrics
• Experience reviewing trial plans, including site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management
• Clinical research knowledge and cross-functional understanding of clinical trial methodology
• Proficient Microsoft Office Suite skills, including Word, Excel, PowerPoint, and Outlook
• Working knowledge of MS Project for clinical study timelines
• Ability to travel as needed; stated travel expectation is 5%
• Global APAC experience desired

Core Competencies

Demonstrates expertise in managing clinical trial operations, ensuring compliance with GCP and ICH guidelines, and effectively overseeing cross-functional teams. Proficient in clinical trial documentation, budget management, and operational feasibility assessments.

Highest-signal resume keywords

• Clinical Trial Management
• GCP Compliance
• Protocol Execution
• Budget Management
• Cross-Functional Team Leadership

ATS Optimization Keywords

Hard Skills

• Clinical Research Experience
• Trial Documentation Preparation
• Site Monitoring
• Risk Mitigation
• Clinical Supplies Management
• Data Review
• Trial Master File Management
• Operational Feasibility Assessment
• Regulatory Requirements Knowledge
• Retina Clinical Trial Support

Soft Skills

• Problem Solving
• Communication
• Team Management

Industry Keywords

• Biotech
• ICH Guidelines
• Clinical Operations
• Audit Readiness
• Service Provider Selection
• Financial Reporting
• Site Contracts
• Global APAC Experience

Tools & Technologies

• Microsoft Office Suite
• MS Project