Senior Study Data Manager & CDM Lead

AstraZeneca; Poland; On-site; PLN 280,000 - 460,000; Full time

Job summary

AstraZeneca in Warsaw seeks an Associate Director Study Data Manager to coordinate CDM deliverables across assigned studies and act as the main contact for the DM vendor. You will ensure data quality, maintain CDM processes, and support GCDMP compliance.

The role emphasizes leadership, project management, and collaboration with global teams, CROs or in-house vendors, with mentoring for junior staff within a Global Study Team.

Qualifications

• Solid knowledge of Clinical Data Management and experience in the Biotech/Pharma/CRO industry.
• Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements.
• Strong Project Management and Lead DM experience; Exhibits expertise in metrics analysis and reporting methodologies.
• Demonstrated ability to work effectively with external partners.
• Demonstrated experience of clinical databases, different clinical data management systems and electronic data capture (EDC).
• Demonstrate understanding and experience in query management process and reconciliation activities.
• Good communication and interpersonal skills including effective problem solving.
• Ability to work independently without close supervision.
• Excellent written and verbal communication skills.
• Ability to work in a global team environment.
• Excellent organizational and analytical skills, sound decision making skills, and high attention to detail.

Responsibilities

• Coordinate CDM deliverables : Coordinate the Clinical Data Management deliverables on assigned studies depending on the relevant DM model and DM Vendor.
• Leadership and delivery : Demonstrates strong leadership, project management skills and operational knowledge in the planning and delivery of CDM deliverables at a study level.
• Collaboration and vendor contact : Communicates and collaborates effectively with all study level team members. Primary point of contact for DM vendor and provides guidance and supervision to Lead Data Manager/DM Team Lead working on the study (CRO or in-house).
• Operational oversight and risk management : Oversight and expertise input into the day-to-day operational aspects of DM for assigned studies; Responsible to identify risks and collaborate with the DM Vendor to mitigate the risks.
• Standards contribution : High level understanding and contribution to corporate, therapeutic/indication and program specific data capture AZ standards.
• Adherence to standards : Drive adherence to AZ DM standards and processes for data quality and consistency of data capturing for assigned studies.
• Inspection preparation : Provide input into DM related activities associated with regulatory inspections/audits for assigned studies. Lead DM inspection preparation for assigned studies.
• Systems, devices, and vendors : May provide input to the selection and use of software systems, devices, and vendors.
• TMF compliance : Responsible for compliance to Trial Master File requirements depending on the relevant DM model and DM Vendor.
• Vendor performance and billing : Support Senior Leaders to oversee DM Vendor performance, depending on relevant model.
• Continuous improvement : Maintain an awareness of the external and internal trends in order to participate in change initiatives and continuous improvement activities related to DM operating models.
• Ad hoc support : Demonstrates willingness to take on ad hoc activities consistent with current work experience in support of DM.
• Mentoring : Mentoring junior Clinical Data Management colleagues.

Skills

CDM knowledge

Regulatory knowledge

Project management

External partners

EDC systems

Query management

Communication

Independent worker

Written communication

Global team

Attention to detail

Education

Life sciences degree

Tools

EDC software

Clinical databases

CDISC standards

Job description

AstraZeneca in Warsaw seeks an Associate Director Study Data Manager to coordinate CDM deliverables across assigned studies and act as the main contact for the DM vendor. You will ensure data quality, maintain CDM processes, and support GCDMP compliance.

The role emphasizes leadership, project management, and collaboration with global teams, CROs or in-house vendors, with mentoring for junior staff within a Global Study Team.