Data Manager - Management

ASTRUM

Matosinhos

On-site

EUR 65,000 - 90,000

Full time

11 days ago

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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

We are seeking a Data Management Manager to lead our Data Management team and ensure the delivery of high-quality, compliant data services across our clinical studies.

Key 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.

Requirements

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.

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