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Associate Director, Study Data Manager
AstraZeneca. Coordinate Clinical Data Management deliverables on assigned clinical studies .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Data Management, including oversight of data management operations, compliance with regulatory standards, and effective collaboration with cross-functional teams. Proficient in metrics analysis, project management, and the use of clinical data management systems to ensure high-quality data capture and reporting.
Highest-signal resume keywords
Clinical Data ManagementGood Clinical Data Management Practices (GCDMP)Project ManagementClinical DatabasesMetrics Analysis
ATS Keywords
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Hard Skills
Clinical Data ManagementMetrics AnalysisProject ManagementQuery ManagementData Standards (CDISC)Database DevelopmentElectronic Data Capture (EDC)Data HandlingRegulatory ComplianceData Management Inspection Preparation
Soft Skills
Effective Problem SolvingExcellent Communication SkillsInterpersonal SkillsOrganizational SkillsAttention to Detail
Tools & Technologies
Clinical Data Management SystemsSoftware SystemsData Management Vendor Performance ToolsTrial Master File Requirements
Industry Keywords
BiotechPharmaCRORegulatory InspectionsPharmaceutical Drug Development
About the role
Key responsibilities & impact- Coordinate Clinical Data Management deliverables on assigned clinical studies
- Serve as the first line of contact at study level and main point of contact for the Data Management vendor
- Lead planning and delivery of CDM deliverables at study level
- Collaborate with study-level team members and provide guidance and supervision to Lead Data Managers/DM Team Leads
- Oversee day-to-day Data Management operations and identify and mitigate risks
- Contribute to corporate, therapeutic/indication, and program-specific data capture standards
- Drive adherence to AstraZeneca Data Management standards and processes
- Provide input into Data Management activities for regulatory inspections and audits
- Lead Data Management inspection preparation for assigned studies
- Provide input into selection and use of software systems, devices, and vendors
- Ensure compliance with Trial Master File requirements
- Oversee Data Management vendor performance, timelines, milestone deliverables, KPIs, budget, billing, and invoices
- Participate in change initiatives and continuous improvement activities
- Perform ad hoc Data Management activities
- Mentor junior Clinical Data Management colleagues
Requirements
What you’ll need- 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
- Current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements
- Strong Project Management and Lead DM experience
- Expertise in metrics analysis and reporting methodologies
- Ability to work effectively with external partners
- Experience with clinical databases, clinical data management systems and electronic data capture (EDC)
- 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
- Demonstrated knowledge of clinical and pharmaceutical drug development process
- Understanding of database structures, programming languages, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting
- Understanding of clinical data system design, development, validation and system interoperability
- Professionalism, diplomacy, mutual respect, and ability to manage and value diversity and cultural differences
- Experience within a Sponsor organization and with Regulatory inspections
Benefits
Comp & perks- Diversity and equality of opportunity
- Inclusive and diverse team environment
- Applications welcomed from all qualified candidates regardless of characteristics
- Compliance with applicable non-discrimination, work authorization, and employment eligibility laws