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- Clinical data management services
- CDISC based clinical data conversion services
- Biostatistics and statistical programming services
- Clinical data transparency and disclosure
- Accenture data operations professionals leverage their domain expertise for authoring data management plans, EDC database design, data review, reconciliation and coding.
- Processing and/or authoring of over 6.5 million case files
- Over 2,000 clinical databases created
- Over 900 clinical databases locked
- Collaboration with sponsor on Integrated Summary of Effective (ISE) and Integrated
- Pooling and analysis activities
- ISS/ISE Statistical Analysis Plan (including Mock Table Listings and Figures)
- ISS/ISE Analysis Datasets from pooled and standardized SDTM database
- ADaM Compliance
- Experience representing sponsors or preparing sponsors for FDA Advisory Committee
- meetings or respective regulatory authority
- Extensive technical knowledge and industry-leading CDISC standards expertise
- Proven track record includes the analysis of over 4,000 datasets
- Clinical Trial and Drug Application Submissions
- Clinical Data Transparency and Anonymization
- RoW Marketing Authorization Submissions
- Document and Dossier Re-formatting
- License Maintenance Submissions
- Dossier Consolidation, Gap Analysis and Remediation
- Submission Continuity Management
- 350+ clients
- One of the largest users of the FDAs electronic gateway
- Support over 90 countries
- Oversees Clinical Data Management functions, which includes line management accountability for all data managers/leads, DIS managers/leads, data strategic operations managers and project team members, planning, coordination to ensure adequate delivery to support all deliverables and support cross functional offerings
- Leads development and delivery of training to build Data Management capabilities among deployed resources
- Leads other capability building activities, as needed, including design of new templates, documentation of best practices, conduct of lessons learned meetings, and other sanctioned activities to improve operational excellence and grow the business
- Drives improved capacity management of data team, including continually assessing capacity needs in data management to support ALSS pipeline, track projects at the task level based on contract commitments
- Verifies/approves project time and expense charges staying within budget
- Single point of escalation for all risks and issues from data managers/leads, DIS managers/leads and team members and escalating to Global ALSS Clinical and Regulatory Delivery and Operations Senior Director, including identifying and escalating trends of issues and risks across portfolios as well as helping to resolve client issues and issues with Sr. Clients
- Drives centralized data management communications with Delivery Lead, Lines of Business Leads, Bus Ops
- Key member of programs to help support and drive change initiatives as well as support strategic growth initiatives under the direction of the Global ALSS Clinical and Regulatory Delivery and Operations Senior Director
- Accountable for delivery of contracted commitments within budget and accuracy of all project information including, forecasts, costing and timelines for projects associated within clinical portfolio of accounts to meet original deal economic targets
- Provides regular status on all aspects of a project to Accenture leadership, particularly raising issues and recommended solutions proactively and in compliance with Accenture's Business Operator policies and best practices
- Supports client relationship development, solutioning, account planning and growth, including identification of new opportunities, tailoring business development activities to the specific client environment, and achieving targeted sales and revenue
- Maintains a strong working knowledge of Standard Operating Procedures, Good Clinical Practices, and Regulatory guidance applicable to project scope.(including corrective action plans and identifying trends)
- Leads team meetings and community building activities for data management line of business broadly and other deployed resources working with the assigned portfolio of accounts.
- Creates synergies with BD/Sales team to meet ALSS business objectives
- Helps to grow accounts and build relationships with clients and potential clients; to include upselling with existing clients
- Ensures that the team strictly adheres to internal standards including Standard Operating Procedures, Guidance Documents, and Policies throughout the lifecycle of the submission
- Manages global network to drive desired business results, maintain quality and meet expectations
Equal Employment Opportunity Statement
All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process.
Accenture is committed to providing veteran employment opportunities to our service men and women.
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