Senior Study Data Manager & CDM Lead (Oncology)

AstraZeneca plc; Barcelona; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

AstraZeneca plc in Barcelona is seeking an Associate Director, Study Data Manager to lead Clinical Data Management delivery across oncology studies. You will guide data quality, mentor junior staff, and ensure compliance with CDM standards and regulatory expectations.

Ownership includes vendor oversight, risk management, and collaboration with cross-functional teams to implement CDASH/SDTM data standards and drive process improvements across study programs.

Qualifications

• Degree in life sciences or related field (pharma, nursing).
• Experience managing multiple trials and meeting deadlines.
• Significant Clinical Data Management experience in CRO and Pharma.

Responsibilities

• Acts as a team leader and provides training to junior colleagues in CDM.
• Performs line management responsibilities like performance appraisals.
• Represents Clinical Data Management in cross-functional forums and with partners.
• Leads CDM activities for regulatory inspections and audits with QA input.
• Oversees vendor contracts, resourcing, budgets, and vendor performance.
• Drives CDASH/SDTM standards and ensures consistency across studies.
• Provides guidance on AZ standards to partners and vendors.
• Manages risks and issues related to CDM processes and technology.

Skills

CDM leadership

Mentoring

GCP knowledge

SDTM/CDASH

Cross-functional collaboration

Vendor management

Education

Life sciences degree

Pharmacy/Nursing related degree

Tools

SQL

R

VBA

SAS

Job description

AstraZeneca plc in Barcelona is seeking an Associate Director, Study Data Manager to lead Clinical Data Management delivery across oncology studies. You will guide data quality, mentor junior staff, and ensure compliance with CDM standards and regulatory expectations.

Ownership includes vendor oversight, risk management, and collaboration with cross-functional teams to implement CDASH/SDTM data standards and drive process improvements across study programs.