Associate Director Study Data Manager

Location: Warsaw

Job Description / Capsule

Responsible to coordinate the Clinical Data Management (CDM) deliverables on assigned clinical studies and may be an expert on CDM processes, standards, and technology. Member of the Global Study Team (GST) and the main point of contact for the Data Management (DM) vendor. Responsible to ensure CDM deliverables follow standards and meet data quality. Maintains business continuity for CDM processes and standards including integrity of the clinical database for the relevant studies. May work under direction of a Project Data Manager.

Typical Accountabilities

• Coordinate CDM deliverables: 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.
• Leadership and delivery: Demonstrates 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.
• 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. Escalates issues/risks as necessary.
• 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. Review, assess and manage DM Vendor delivery against KPIs, budget and overall performance. Oversees vendor timelines and milestone deliverables for the assigned studies. Ensures DM Vendor billing is accurate and gives recommendations for payment of invoices 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.

Education, Qualifications, Skills and Experience

Essential

• Degree: University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree.
• CDM knowledge: Solid knowledge of Clinical Data Management and experience in the Biotech/Pharma/CRO industry.
• Regulatory understanding: Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements.
• Project management: Strong Project Management and Lead DM experience; Exhibits expertise in metrics analysis and reporting methodologies.
• External partners: Demonstrated ability to work effectively with external partners.
• Systems and EDC: Demonstrated experience of clinical databases, different clinical data management systems and electronic data capture (EDC).
• Query management and reconciliation: Demonstrate understanding and experience in query management process and reconciliation activities.
• Communication and problem solving: Good communication and interpersonal skills including effective problem solving.
• Independent working: Ability to work independently without close supervision.
• Written and verbal communication: Excellent written and verbal communication skills.
• Global team environment: Ability to work in a global team environment.
• Organization and analysis: Excellent organizational and analytical skills, sound decision making skills, and high attention to detail.

Desirable

• Drug development knowledge: Demonstrated knowledge of clinical and pharmaceutical drug development process.
• Technical understanding: State of the art understanding of database structures, programming languages, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting.
• System design and interoperability: Demonstrated understanding of clinical data system design / development / validation and system interoperability.
• Professionalism and diversity: Demonstrates professionalism, diplomacy, mutual respect and the ability to manage/value diversity and cultural differences and promote productivity through encouragement.
• Sponsor and inspections: Experience within Sponsor organization and Regulatory inspections.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  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.