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, reporting directly to the Global R&D Operations Lead, primary responsibilities include:

  • oversee global Clinical Operations for a portfolio of Life Sciences clients, including: line management responsibility for all North America team members as well as operational accountability for global delivery, capacity and resource management of the clinical delivery teams, forecasting and planning of work, and coordination with other functions to ensure delivery of a clinical portfolio;
  • provide senior support and oversight of issue and risk management and delivery-related escalations (including client meetings as needed);
  • provide oversight of talent management and training programs to ensure that the right resources are delivering the right work from the right location;
  • ensure delivery is aligned with all regulatory and operational requirements for compliant delivery, including proactive risk mitigation related to people, process and technology;
  • responsible for all commercial and financial aspects of the assigned clinical operations portfolio, including providing input into annual planning activities and ongoing commercial risk management;
  • support business development-related activities, including representing Clinical Operations on sales pursuits teams, providing Clinical Operations insights into business strategy, representing Clinical Operations at industry forums, and meeting with clients in support of overall account management activities.

The individual in this role will be a key contributor to set strategic direction and define the future vision of Clinical Operations, with a focus on driving innovation, and enabling and scaling ways of working in the delivery organization. The individual in this role will also be a key member of the senior R&D Operations leadership team, working collaboratively with sales, account management, other R&D Operations leads, consulting and technology to drive strategy and bring the best of Accenture to a portfolio of Life Sciences clients.

 


Accenture Carnival

Carnival Corporation reimagines guest experiences with high-touch tech.
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.

Accenture is 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.

Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.

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.

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.

Stay Connected

Stay Connected

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