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Associate Director Study Data Manager
3 months ago
Join our team as an Associate Director Study Data Manager, where you will be tasked with coordinating Clinical Data Management (CDM) deliverables for assigned clinical studies. As a member of the Global Study Team (GST), you will act as the primary point of contact for the Data Management (DM) vendor, ensuring that CDM deliverables adhere to standards and uphold data quality. This role presents an opportunity to uphold business continuity for CDM processes and standards, playing a crucial role in maintaining the integrity of the clinical database for relevant studies.
Accountabilities:As an Associate Director Study Data Manager, your responsibilities will include coordinating Clinical Data Management deliverables for assigned studies, serving as the primary contact at the study level, and showcasing strong leadership and project management skills. You will identify risks and collaborate with the DM Vendor to address them, provide input into DM-related activities linked to regulatory inspections/audits for assigned studies, and oversee DM Vendor performance.
Essential Skills/Experience:- University or college degree in life sciences or related field, such as pharmacy, nursing, or a relevant equivalent degree.
- Solid expertise in Clinical Data Management and experience in the Biotech/Pharma/CRO industry.
- Current understanding of Good Clinical Data Management Practices (GCDMP) and pertinent regulatory requirements.
- Proficiency in Project Management and leading DM roles, with an emphasis on metrics analysis and reporting methodologies.
- Effective collaboration with external partners.
- Experience with clinical databases, various clinical data management systems, and electronic data capture (EDC).
- Understanding and experience in query management processes and reconciliation activities.
- Strong communication and interpersonal skills, including adept problem-solving abilities.
- Capability to work independently with minimal supervision.
- Excellent written and verbal communication skills.
- Ability to function in a global team setting.
- Outstanding organizational and analytical skills, strong decision-making abilities, and meticulous attention to detail.
- Knowledge of clinical and pharmaceutical drug development processes.
- Familiarity with database structures, programming languages, data standards (CDISC), and practices as they relate to CRF design, database development, data handling, and reporting.
- Comprehension of clinical data system design, development, validation, and system interoperability.
- Professionalism, diplomacy, mutual respect, and adeptness in managing diverse cultures.
- Experience within Sponsor organization and Regulatory inspections.
By bringing diverse teams together, we ignite innovative thinking with the power to facilitate groundbreaking medical advancements. Our in-person collaboration fosters connections, facilitates rapid work, and challenges assumptions. While we typically work at the office for a minimum of three days per week, we value flexibility and respect individual needs. Join us in our distinctive and ambitious environment.
In AstraZeneca's Oncology R&D department, we are at the forefront of scientific exploration to revolutionize medical practices and enhance the lives of cancer patients. Our unified vision is to eradicate cancer as a life-threatening illness. With one of the most extensive Oncology pipelines in the field, you will find numerous opportunities to engage with cutting-edge medications. We believe in collective growth, offering a platform where everyone's voice is heard. Committed to our science-driven strategy, we emphasize courage, empowering all to innovate, step up, and work swiftly.
Ready to bring about meaningful change in the lives of patients?
Date Posted31-May-2024Closing Date04-Jun-2024