Freelance Evidence Generation Data Manager

We have a current opportunity for a Freelance Evidence Generation Data Manager on a contract basis. The position will be based in München. For further information about this position please apply.

Freelance Evidence Generation Data Manager

Key Responsibilities

• Serve in an advisory and autonomous role to guide the operational development and execution of Risk‑Based Quality Management (RBQM) components designed for risk identification, mitigation, and ongoing oversight within non‑interventional studies.
• Offer technical leadership in building and managing a comprehensive Key Risk Indicator (KRI) framework, including dashboards, a centralized statistical monitoring environment, and an audit‑trail review module; collaborate with the team to determine whether internal capabilities or external solutions are most suitable.
• Support the evaluation, piloting, and rollout of centralized monitoring workflows aimed at strengthening study oversight and ensuring high data integrity.

Requirements

• A Bachelor's or Master's degree in Life Sciences, Pharmacy, Biostatistics, Data Science, Public Health, or a closely related field is preferred.
• At least 7 years of professional experience in clinical research, ideally in centralized monitoring, data management, biostatistics, or in a Clinical Research Associate (CRA) capacity.
• Deep understanding of risk‑based quality management aligned with current industry guidelines and established best practices.
• Fluent English , with German considered an asset but not essential.
• Demonstrated expertise in:
• Developing and implementing RBQM elements to support centralized monitoring
• Conducting and providing specialized input for non‑interventional study activities
• Applying methodologies for risk assessment, monitoring strategies, and mitigation approaches
• Designing, building, and deploying Key Risk Indicators (KRIs)
• Executing and managing centralized monitoring operations, including hands‑on use of relevant systems and technologies
• Applying data‑driven oversight across clinical studies , including detection of risk signals and quality concerns through statistical evaluations, trend monitoring, and continuous data review
• Providing expert judgment on early identification of data irregularities, protocol deviations, safety concerns, and operational risks to enable targeted actions, streamlined processes, and adherence to GCP and RBM standards
• Highly organized and conscientious capable of working independently while maintaining alignment with cross‑functional teams.
• Adaptable and resilient , with the ability to prioritize effectively i

Start: 1.3.26

Remote

Freelance

SThree_Germany is acting as an Employment Business in relation to this vacancy.