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Job Overview
Location
Remote
Job Type
Full-time
Category
Data Engineer
Date Posted
January 30, 2026
Full Job Description
đź“‹ Description
- • Join AbbVie, a global biopharmaceutical leader dedicated to discovering and delivering innovative medicines that address serious health challenges and improve lives. We are seeking a highly motivated and experienced Associate Director - Data Management Operations, specializing in Solid Tumor or Hematology, to play a pivotal role in our cutting-edge research and development efforts.
- • This is a hybrid role, offering the flexibility to work remotely while also fostering collaboration and connection through occasional in-office presence. You will be instrumental in ensuring the integrity, accuracy, and efficiency of clinical trial data, which is fundamental to bringing life-changing therapies to patients.
- • As an Associate Director, you will lead and manage a team of data management professionals, providing strategic direction and operational oversight for data management activities across multiple clinical trials. Your leadership will be crucial in setting high standards for data quality, compliance, and timely delivery of critical data sets.
- • You will be responsible for the development, implementation, and execution of data management plans (DMPs) that align with study protocols, regulatory requirements, and AbbVie's internal standards. This includes defining data collection methods, database design, edit check specifications, data validation procedures, and data cleaning strategies.
- • A key aspect of your role will involve collaborating closely with cross-functional teams, including clinical operations, biostatistics, programming, medical affairs, regulatory affairs, and external vendors. You will serve as the primary point of contact for data management aspects of assigned studies, ensuring seamless communication and alignment.
- • You will oversee the design, build, and validation of clinical databases using industry-leading EDC systems, ensuring they meet the complex needs of oncology and hematology studies. This includes managing user acceptance testing (UAT) and ensuring all database configurations are robust and compliant.
- • Your responsibilities will extend to managing data review activities, including the development and execution of data review plans, query generation and resolution, and reconciliation of external data. You will ensure that data is clean, consistent, and ready for statistical analysis in a timely manner.
- • You will play a critical role in the selection and management of third-party data management vendors, ensuring they meet performance expectations, quality standards, and contractual obligations. This includes conducting vendor audits and providing ongoing performance feedback.
- • A significant part of your contribution will be in driving process improvements and implementing best practices within the data management function. You will identify opportunities to enhance efficiency, reduce timelines, and improve data quality through the adoption of new technologies and methodologies.
- • You will ensure that all data management activities are conducted in strict adherence to Good Clinical Practice (GCP), regulatory guidelines (e.g., FDA, EMA), and AbbVie's Standard Operating Procedures (SOPs). This includes maintaining comprehensive audit trails and ensuring data traceability.
- • You will contribute to the development and maintenance of data management SOPs, work instructions, and training materials, ensuring that the team is equipped with the knowledge and tools to perform their roles effectively.
- • Your expertise in Solid Tumor or Hematology oncology will be invaluable in understanding the specific data requirements and challenges associated with these complex therapeutic areas. You will be adept at interpreting clinical protocols and translating them into actionable data management strategies.
- • You will be responsible for resource planning and allocation for data management activities, ensuring adequate staffing and expertise to support the clinical development pipeline.
- • This role offers the opportunity to make a tangible impact on the development of novel cancer therapies, contributing directly to AbbVie's mission of improving patient outcomes. You will be part of a dynamic and collaborative environment where innovation and scientific excellence are highly valued.
- • You will mentor and develop team members, fostering a culture of continuous learning, high performance, and professional growth. Your leadership will inspire and guide the team to achieve ambitious goals.
- • You will participate in regulatory inspections and audits, providing data management expertise and ensuring that all documentation is accurate and readily available.
- • You will stay abreast of industry trends, emerging technologies, and regulatory changes in data management and clinical research, bringing this knowledge back to the team and implementing relevant advancements.
- • Your strategic thinking will be essential in anticipating potential data management challenges and proactively developing mitigation plans to ensure project success.
- • This position requires a strong understanding of clinical trial processes, data standards (e.g., CDISC), and the regulatory landscape governing pharmaceutical development.
- • You will be a key contributor to the overall success of clinical development programs, ensuring that high-quality data is available to support critical decision-making and regulatory submissions.
- • Ultimately, you will be a champion for data integrity and a driving force in delivering accurate, reliable, and timely data that underpins the development of life-saving medicines.
🎯 Requirements
- • Minimum of 8 years of progressive experience in clinical data management within the pharmaceutical or biotechnology industry, with a significant focus on oncology (Solid Tumor or Hematology).
- • Proven experience in leading and managing data management teams and projects, including vendor oversight.
- • Deep understanding of clinical trial processes, data management systems (EDC, CTMS, etc.), data standards (CDISC SDTM/ADAM), and regulatory requirements (GCP, ICH).
Skills & Technologies
Junior
Remote
About AbbVie Inc.
AbbVie is a global biopharmaceutical company that discovers, develops, manufactures, and markets advanced therapies and medicines. Its portfolio spans immunology, oncology, neuroscience, eye care, and other serious health conditions. The company invests heavily in research and development to address unmet medical needs worldwide.
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