Senior Study Data Manager & CDM Lead

AstraZeneca; Warszawa; On-site; PLN 350,000 - 520,000; Full time

Job summary

AstraZeneca in Warsaw seeks an Associate Director Study Data Manager to coordinate Clinical Data Management deliverables on assigned studies. You will be the main point of contact for the DM vendor and ensure data quality and standards across programs.

The role requires solid CDM knowledge, project management experience, and the ability to work with external partners in a global team environment. Strong communication and analytical skills are essential.

Qualifications

• Degree in life sciences or related field.
• Solid CDM knowledge in biotech/pharma/CRO.
• Understanding of GCDMP and regulatory requirements.
• Project management experience with Lead DM exposure.
• Experience working with external partners.
• Experience with EDC and clinical databases.
• Query management and reconciliation experience.
• Strong communication and problem-solving skills.
• Ability to work independently.
• Global team environment experience.
• Strong organizational and analytical skills.

Responsibilities

• Coordinate CDM deliverables on assigned studies and DM model.
• Lead and mentor DM staff; act as study-level contact for vendors.
• Collaborate with study team and DM vendor to ensure data quality.
• Identify risks and mitigate with vendor; escalate as needed.
• Support inspection readiness and DM-related audits.
• Contribute to standards for data capture and TMF compliance.
• Provide input on vendor performance and KPI delivery.

Skills

CDM knowledge

Regulatory understanding

Project management

External partners

EDC/databases

Education

University degree in life sciences or related field

Experience in Biotech/Pharma/CRO

Job description

AstraZeneca in Warsaw seeks an Associate Director Study Data Manager to coordinate Clinical Data Management deliverables on assigned studies. You will be the main point of contact for the DM vendor and ensure data quality and standards across programs.

The role requires solid CDM knowledge, project management experience, and the ability to work with external partners in a global team environment. Strong communication and analytical skills are essential.