Associate Director Study Data Manager

AstraZeneca•Durham, NC

2d•Hybrid

About The Position

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects. Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. Introduction to Role: 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

Requirements

University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree.
8 years of experience
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 distributed team environment.
Excellent organizational and analytical skills, sound decision making skills, and high attention to detail.

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.
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 mentorship 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. Advances issues/risks as vital.
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 critical metrics, budget and overall performance. Oversees vendor timelines and achievement 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