Join to apply for the Associate Director Study Data Manager role at AstraZeneca

Location: Warsaw, Poland

Hybrid model of work: 3 days in office, 2 remote

Responsibilities

• Coordinate the Clinical Data Management deliverables on assigned studies depending on the relevant DM model and DM Vendor. Takes accountability and serves as the first line of contact at the study level.
• Demonstrate strong leadership, project management skills and operational knowledge in the planning and delivery of CDM deliverables at a study level, potentially under mentorship from a Project Data Manager.
• Communicate and collaborate effectively with all study level team members. Primary point of contact for DM vendor and provide guidance and supervision to Lead Data Manager/DM Team Lead working on the study (CRO or in-house).
• Provide oversight and input into the day-to-day operational aspects of DM for assigned studies; identify risks and collaborate with the DM Vendor to mitigate them. Escalate issues/risks as necessary.
• Contribute to corporate, therapeutic/indication and program specific data capture AZ standards.
• Drive adherence to AZ DM standards and data quality practices for data capture in assigned studies.
• Provide input into DM activities related to regulatory inspections/audits for assigned studies. Lead DM inspection preparation for assigned studies.
• May contribute to the selection and use of software systems, devices, and vendors.
• Ensure compliance with Trial Master File requirements depending on the relevant DM model and DM Vendor.
• Support Senior Leaders to oversee DM Vendor performance, review and manage DM Vendor delivery against KPIs, budget and overall performance. Monitor vendor timelines and milestone deliverables; oversee invoicing and advise on payments where applicable.
• Maintain awareness of external and internal trends to participate in change initiatives and continuous improvement activities related to DM operating models.
• Demonstrate willingness to take on ad hoc activities aligned with current experience to support DM, and mentor junior Clinical Data Management colleagues.

Essential

• University or college degree in life sciences or related subject, pharmacy, nursing or equivalent.
• Solid knowledge of Clinical Data Management and experience in Biotech/Pharma/CRO industries.
• Current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements.
• Strong Project Management and Lead DM experience; expertise in metrics analysis and reporting methodologies.
• Ability to work effectively with external partners.
• Experience with clinical databases, different CDM systems and electronic data capture (EDC).
• Understanding of query management and reconciliation activities.
• Good communication and interpersonal skills, including 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, and high attention to detail.

Desirable

• Knowledge of clinical and pharmaceutical drug development processes.
• Understanding of database structures, programming languages, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting.
• Understanding of clinical data system design/development/validation and system interoperability.
• Professionalism, diplomacy, respect for diversity, and ability to promote productivity through collaboration.
• Experience within Sponsor organizations and regulatory inspections.

Other

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with a wide range of perspectives, and harnessing industry-leading skills. We comply with all applicable laws and regulations on non-discrimination in employment and recruitment, as well as work authorization and employment eligibility verification requirements.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Business Development and Sales

Industries

• Pharmaceutical Manufacturing