Clinical Trial Managers (SMLs) sponsor dedicated in Germany

Stellenbeschreibung:

Overview

In this role, you will lead clinical trial operations for sponsor-specific partnerships in Germany, overseeing site and central monitoring with a focus on patient safety and data integrity. You will collaborate with cross-functional teams to manage risks, budgets, and timelines, ensuring regulatory and GCP compliance. You’ll engage with investigators and sites, drive study milestones, and optimize monitoring and trial management processes. This position offers impactful work within a global organization that supports patient progress and innovative drug development.

Leistungen / Benefits

career development
inclusive culture
total rewards program

Verantwortungsbereiche

Oversee site management and central monitoring deliverables with focus on patient safety, protocol/GCP/regulatory compliance and data integrity
Manage site interactions from activation to closeout, including patient recruitment and investigator payments as needed
Identify data and process risks, and implement mitigations using the RACT framework
Review study scope, budget, and protocol content; ensure CRAs/CeMs understand contractual obligations
Escalate risks to project manager related to timeline, quality, budget, or scope
Present and participate in key meetings (e.g., Kick Off) and coordinate with Study Start Up, Patient Recruitment, and Data Management
Develop and maintain clinical study tools/templates (e.g., Clinical Monitoring Plan); ensure CTMS and dashboards are ready and usable
Provide initial and ongoing training on protocol specifics, CRF completion, dashboards, SOPs, data plans, and timelines
Oversee resource allocations for CRAs and Central Monitors; ensure quality of monitoring deliverables
Monitor and review CTMS/EDC/eDiary/ePROs/TMF/IVRS dashboards to reflect timely operational execution
Ensure monitoring strategy alignment with CMP/SMP and risk plans; ensure staff compliance and delivery
Interact with clients and other functions, providing status updates and solutions for protocol execution obstacles
Support inspection readiness and QA activities; develop corrective action plans as needed
Mentor and coach CTMs on clinical delivery and risk evaluation
May coordinate activities for larger trials or across a portfolio; travel up to ~20%

Zentrale Anforderungen

Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience
Ability to lead and align teams to achieve project milestones
Experience working in an international environment
Expertise in site management and monitoring (clinical or central)
Knowledge of risk-based monitoring (preferred)
Understanding of clinical trial management financial principles and budget management
Knowledge of GCP/ICH guidelines and regulatory requirements
Good computer skills; strong conflict resolution and problem-solving abilities
Ability to apply risk management to identify and mitigate threats; critical thinking to resolve issues
Moderate travel (~20%)