Associate Director Study Data Manager

AstraZeneca GmbH; Barcelona; Presencial; EUR 70.000 - 100.000; Jornada completa

Descripción de la vacante

A leading company in the pharmaceutical sector is seeking an Associate Director Study Data Manager in Barcelona. You will play a crucial role in coordinating clinical data management deliverables and ensuring high data quality standards are met across various studies. This position offers the opportunity to lead a global team and directly impact clinical trial success.

Formación

• Solid knowledge and experience in Clinical Data Management within Biotech/Pharma/CRO.
• Proficiency with clinical databases and EDC systems.
• Ability to work independently and within a global team.

Responsabilidades

• Coordinate CDM deliverables for assigned studies.
• Lead and project manage CDM tasks at a study level.
• Oversee DM vendor performance and manage budgets and KPIs.

Conocimientos

Project management

Leadership

Communication

Problem-solving

Clinical Data Management

Educación

Degree in life sciences, pharmacy, nursing

Herramientas

Clinical databases

EDC systems

Descripción del empleo

Location: Barcelona, Spain (3 days working from the office)

As an Associate Director Study Data Manager at AstraZeneca, you will play a crucial role in coordinating Clinical Data Management deliverables for assigned clinical studies. You will be a key member of the Global Study Team, serving as the main point of contact for the Data Management vendor and ensuring that CDM deliverables adhere to standards and maintain data quality. Reporting to a Project Data Manager, you will uphold business continuity for CDM processes and standards, safeguarding the integrity of clinical databases across relevant studies.

Key Responsibilities:

• Coordinate CDM deliverables for assigned studies.
• Lead and project manage CDM tasks at a study level.
• Serve as a primary contact for DM vendors, providing guidance and oversight.
• Manage operational tasks and mitigate risks in collaboration with DM vendors.
• Drive standards and process adherence for data quality.
• Support regulatory inspections and audits related to DM activities.
• Oversee DM vendor performance and manage budgets and KPIs.
• Engage in continuous improvement activities within DM operations.

Qualifications:

• Essential:

  • Degree in life sciences, pharmacy, nursing, or a related field.
  • Solid knowledge and experience in Clinical Data Management within Biotech/Pharma/CRO.
  • Strong project management and leadership skills.
  • Proficiency with clinical databases and EDC systems.
  • Excellent communication and problem-solving skills.
  • Ability to work independently and within a global team.

• Desirable:

  • Understanding of clinical drug development processes.
  • Experience with database structures and programming languages.
  • Familiarity with data standards like CDISC.
  • Experience with Sponsor organizations and regulatory inspections.