Job Description

Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions – underpinned by the world’s largest delivery network – Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 425,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. 


 

Visit us at www.accenture.com.


 

People in our Client Delivery & Operations career track drive delivery and capability excellence through the design, development and/or delivery of a solution, service, capability or offering. They grow into delivery-focused roles, and can progress within their current role, laterally or upward.

This role resides within Accenture's Applied Life Sciences Solutions (ALSS) group. This group helps clients make a meaningful impact on patients’ lives by combining new science with leading-edge technology. We’re working with our clients to revolutionize how medical treatments are Discovered, Developed and Delivered.  Helping 90% of the Fortune 500 life sciences companies (including all of the Top Ten) with 15,000+ life sciences professionals in 50+ countries.

 
Clinical Operations services we provide:
  • 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.

 
Accomplishments: 
  • Processing and/or authoring of over 6.5 million case files
  • Over 2,000 clinical databases created
  • Over 900 clinical databases locked

 
Clinical Statistics and Programming services we provide:
  • Collaboration with sponsor on Integrated Summary of Effective (ISE) and Integrated 

 
Summary of Safety Strategy (ISS): 
  • 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

 
Accomplishments:
  • 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

 
Regulatory Services we provide:
  • 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

 
Regulatory Accomplishments
  • 350+ clients 
  • One of the largest users of the FDAs electronic gateway
  • Support over 90 countries 

 
The Data Operations Lead reports directly to the Global Clinical and Regulatory Delivery and Operations Managing Director, primary responsibilities will include the following:
  • 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

 

Smart New Digital Services for Schneider Electric
Read More

Qualifications

Basic Qualifications: 
· Bachelor’s degree 
· Minimum 6 years’ experience managing employees 
· Minimum 5 years’ experience with clinical life cycle management/clinical trial research and regulatory guidance 
· Minimum 5 years’ experience in a client facing role

Preferred Skills
· Knowledge and experience with multiple industry Electronic Data Capture and Study Data Tabulation Model tools 
· Experience and understanding of the Contract Research Organization environment 
· Thorough knowledge of medical terminology 
· Knowledge of Good Clinical Practices, International Council of harmonisation, and other applicable regulations 
· Knowledge of quality assurance processes in a FDA regulated software development environment 
· Knowledge and experience with multiple industry EDC and SDTM tools

Preferred Professional Skills
· Excellent communication skills (written and oral) 
· Good organizational, multi-tasking, time-management skills and managing many competing projects 
· Proven abilities to manage and transform complex projects, work with multi-disciplinary teams and manage clinical data management projects 
· Proven abilities to manage project scope, resources, and financials 
· Proven abilities motivating and managing teams of other project managers or service delivery professionals 
· Strong interpersonal, technical and leadership skills 
· Proven business skills and operational management experience is essential
· Self-directed and detailed-oriented


Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Accenture.

Accenture is a federal contractor and an EEO and Affirmative Action Employer of Females/Minorities/Veterans/Individuals with Disabilities.

Equal Employment Opportunity
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.

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.

Stay Connected

Join our Team

Join Our Team

Search open positions that match your skills and interest. We look for passionate, curious, creative and solution-driven team players.

SEARCH ACCENTURE JOBS
Keep up to date

Keep Up to Date

Stay ahead with careers tips, insider perspectives, and industry-leading insights you can put to use today–all from the people who work here.

READ CAREERS BLOG
Stay Connected

Stay Connected

Receive job alerts, latest news and insider tips tailored to your preferences. See what exciting and rewarding opportunities await.

JOIN TALENT COMMUNITY

Protection Privacy Safeguards

For further information, visit our website: careers.accenture.com
For information on our Privacy Protection Safeguards art13 L.679/2016 (GDPR) go to https://www.accenture.com/us-en/careers/privacy-policy
Accenture is an equal opportunities employer and welcomes applications from all sections of society and does not discriminate on grounds of race, religion or belief, ethnic or national origin, disability, age, marital, domestic or civil partnership status, sexual orientation, gender identity, or any other basis as protected by applicable law.
If you would like to be considered for employment opportunities with Accenture and need special assistance due to a disability or accommodation for a disability, please call us at 1 (612) 234-8836 or send us an email.