Associate Director Study Data Manager job opportunity at AstraZeneca.

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AstraZeneca Associate Director Study Data Manager
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loacation India - Bangalore, India
loacation India - Bangal..........India

Job Title: Associate Director Study Data Manager Introduction to role: Are you ready to lead study-level data management that accelerates breakthrough medicines to patients? In this role, you will take ownership of the integrity, timeliness and inspection readiness of clinical data across assigned studies, making sure evidence is reliable and decision-ready. You will orchestrate delivery with a mix of internal teams and external partners, setting standards, governing vendors and resolving risks at pace. Your leadership will directly shape how data is collected, curated and reported, using modern approaches and tools so study teams can move faster with confidence. Positioned at the heart of pivotal trials, you will connect scientific ambition with operational excellence. How will you use your expertise to strengthen the pipeline and ensure high-quality data that stands up to regulatory scrutiny and ultimately benefits patients worldwide? Accountabilities: Study-Level Leadership and Ownership: Serve as the first line of contact for data management at the study level, setting direction, coordinating results and ensuring alignment to goals and timelines. Vendor Partnership and Governance: Act as primary point of contact for the DM vendor; guide and supervise the Lead Data Manager/DM Team Lead (CRO or in-house) to deliver consistent, high-quality outcomes. Risk Management and Issue Customer concern: Identify operational risks early, collaborate with the DM vendor on mitigation plans, and advance issues swiftly to protect study integrity and timelines. Standards and Quality Stewardship: Drive adherence to data capture and AZ DM standards and processes to improve data consistency, usability and downstream analysis across assigned studies. Inspection Readiness and Audit Support: Lead preparation for DM-related inspections and audits, giving expert input and ensuring robust documentation and process compliance. Trial Master File Compliance: Ensure DM documentation meets Trial Master File requirements aligned to the operating model and vendor responsibilities. Technology and Vendor Insight: Provide input into the selection and use of software systems, devices and vendors to strengthen data flow, quality and efficiency. Performance, indicators and Budget Oversight: Review and manage DM vendor delivery against indicators, budget and achievements; be responsible for timelines and verify billing accuracy, recommending invoice payment when appropriate. Continuous Improvement and Change: Stay alert to internal and external trends; participate in operating model improvements that enhance speed, quality and reliability. Mentorship and Collaboration: Communicate effectively with study teams and mentor junior CDM colleagues, building capability and shared accountability that scales across programs. Can you foresee risks and steer vendors to deliver reliable data at pace? Essential Skills/Experience: Coordinate the Clinical Data Management results 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 results 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. 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 lead DM Vendor delivery against indicators, budget and overall performance. Oversees vendor timelines and achievement results 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. Desirable Skills/Experience: Experience leading complex, multi-region trials across multiple DM operating models and CROs. Proven track record in inspection readiness and contributing to successful health authority interactions for DM. Strong familiarity with EDC platforms, medical devices and connected sensors, and end-to-end clinical data flow architectures. Ability to apply digital and analytics approaches to improve data quality, edit checks and operational predictability. Broad exposure to multiple therapeutic areas and program phases, from early-stage through late-stage development. Professional certification or affiliation related to clinical data management (e.g., SCDM). When we put unexpected teams in the same room, we ignite bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. Why AstraZeneca: Join a science-led company where your expertise in study data management fuels real progress from the lab to the clinic. We unite diverse teams and partners to push boundaries, harnessing digital, data science and AI to accelerate evidence generation and strengthen a rich pipeline. Your work will sharpen the quality of clinical decisions, speed promising medicines to those who need them, and thrive in a collaborative culture that values kindness alongside bold ambition. Call to Action: Seize this opportunity to own study-level data that powers life-changing medicines and elevate your impact—apply today! Date Posted 28-Jan-2026 Closing Date 03-Feb-2026 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.

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