Clinical Data Management Lead for Regulated Trials

Astrum CRO; Matosinhos; On-site; EUR 65,000 - 90,000; Full time

Job summary

Astrum CRO is seeking a Data Management Manager to lead our Data Management team and ensure delivery of high-quality, compliant data services across clinical studies. The ideal candidate will oversee data management deliverables, manage budgets and KPIs, and drive process improvements in a regulated environment.

You will partner with cross-functional teams and support business development with strategic data management capabilities.

Qualifications

• Degree in a technical, scientific or related field.
• Strong knowledge of Data Management processes, database design and CDISC/CDASH standards.
• Solid understanding of regulatory requirements, including FDA, EMA and ICH guidelines, as well as risk-based quality management.
• Proven experience leading teams in a regulated environment.
• Strategic, client-focused mindset with excellent communication skills.

Responsibilities

• Lead and develop the Data Management team, overseeing workload, resource allocation and performance.
• Oversee key Data Management deliverables, including DMPs, DVPs and UAT documentation, ensuring quality and inspection readiness.
• Identify and mitigate risks affecting data quality, timelines and budgets, and ensure the timely implementation of CAPAs.
• Monitor departmental budgets and KPIs while driving process improvements and operational efficiency.
• Support business development activities through budget specifications, capability presentations and bid defences.

Skills

Data management knowledge

Regulatory knowledge

Leadership

Strategic thinking

Communication skills

Education

Bachelor's degree in a technical field

Job description

Astrum CRO is seeking a Data Management Manager to lead our Data Management team and ensure delivery of high-quality, compliant data services across clinical studies. The ideal candidate will oversee data management deliverables, manage budgets and KPIs, and drive process improvements in a regulated environment.

You will partner with cross-functional teams and support business development with strategic data management capabilities.