Associate Director, Study Data Manager

Associate Director Study Data Manager

Location: Warsaw, hybrid work (3 days from office, 2 days from home)

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 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.
• 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.
• 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).
• 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.
• High level understanding and contribution to corporate, therapeutic/indication and program specific data capture AZ standards.
• Drive adherence to AZ DM standards and processes for data quality and consistency of data capturing for assigned studies.
• Provide input into DM related activities associated with regulatory inspections/audits for assigned studies. Lead DM inspection preparation for assigned studies.
• May provide input to the selection and use of software systems, devices, and vendors.
• Responsible for compliance to Trial Master File requirements depending on the relevant DM model and DM Vendor.
• 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.
• 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.
• Demonstrates willingness to take on ad hoc activities consistent with current work experience in support of DM.
• Mentoring junior Clinical Data Management colleagues

Education, Qualifications, Skills and Experience:

Essential:

• University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree.
• 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.

Desirable:

• Demonstrated knowledge of clinical and pharmaceutical drug development process.
• 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.
• Demonstrated understanding of clinical data system design / development / validation and system interoperability.
• Demonstrates professionalism, diplomacy, mutual respect and the ability to manage/value diversity and cultural differences and promote productivity through encouragement.
• 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.