Capgemini is an Equal Opportunity Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, national origin, gender identity/expression, age, religion, disability, sexual orientation, genetics, veteran status, marital status or any other characteristic protected by law.
This is a general description of the Duties, Responsibilities and Qualifications required for this position. Physical, mental, sensory or environmental demands may be referenced in an attempt to communicate the manner in which this position traditionally is performed. Whenever necessary to provide individuals with disabilities an equal employment opportunity, Capgemini will consider reasonable accommodations that might involve varying job requirements and/or changing the way this job is performed, provided that such accommodations do not pose an undue hardship.
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Capgemini is a global leader in consulting, digital transformation, technology and engineering services. The Group is at the forefront of innovation to address the entire breadth of clients’ opportunities in the evolving world of cloud, digital and platforms. Building on its strong 50-year+ heritage and deep industry-specific expertise, Capgemini enables organizations to realize their business ambitions through an array of services from strategy to operations. Capgemini is driven by the conviction that the business value of technology comes from and through people. Today, it is a multicultural company of 270,000 team members in almost 50 countries. With Altran, the Group reported 2019 combined revenues of €17billion.
Visit us at www.capgemini.com. People matter, results count.
Role Name/Description: Clinical Development
•L2/L3 Support: Service requests, incident resolution, release management, minor enhancement on list of regulatory submission applications.
•Performing Computer System Validation activities and authoring documents for clinical development and trials in the Biotech/Pharmaceutical Industry.
•Ensuring the compliance to the requirements of clinical development/trials procedures, GCP and FDA regulations and understanding of early phase drug development process.
•Coordinate with business to understand requirement for clinical research and associated trails for related configurations and enhancements.
•The person must come from IT Departments (R&D IT support) from Pharma or/and Biotech industries and should have ITIL knowledge (Incident/Change/Knowledge/Problem Management).
•Thorough understanding of the features and functions of all core clinical research technologies commonly used in the industry, and experience of supporting these applications (EDC, CTMS, CDMS, eTMF, SAS, reporting, RTSM).
•Excellent knowledge of FDA and GCP regulations and how these apply to application design, development and testing of applications in the Pharmaceutical industry
•Experienced in cross-functional, multicultural and international clinical trial teams preferable.
•Should be good in troubleshooting/debugging of Issues encountered in Web applications.
•Technical Skills: Configurations of multiple platforms like Veeva, Rave and SAS etc, Linux/Unix Commands, PLSQL/SQL, Unix Shell Scripting
•Knowledge of following clinical development applications:
SAS DD [Drug Development]
Veeva Vault eTMF
Impact/CTMS Veeva CTMS
Sycamore CDR [Clinical Data Repository]
Helpful Skill : SharePoint, Power BI, QlikView, Tableau for reporting dashboard, SAS Analytics/ SAS JMP
Key Words (for sourcing):
•Veeva Vault eTMF
•R&D – Clinical Development
Applications Consultants have expertise in a specific technology environment. They are responsible for software-specific design and realization, as well as testing, deployment and release management, or technical and functional application management of client-specific package based solutions (e.g. SAP, ORACLE). These roles also require functional and methodological capabilities in testing and training.
Required Skills and Experience:
You focus on building solutions and on maintaining, optimizing and improving a client’s applications and systems. You contribute to a business and technical blueprint and customize the respective Software Package Core Module. You may also be responsible for unit testing, contribute to integration testing, and/or be responsible for the design and delivery of end-user training.
• Qualification: 2-5 years (1 year min relevant experience in the role) experience, Bachelor’s Degree.
• Certification: Should have or seeking SE Level 1.
• Should be proficient in Package Configuration.
• Should have progressing skills in Business Analysis, Business Knowledge, Testing, Architecture Knowledge, Technical Solution Design and Vendor Management
Candidates should be flexible / willing to work across this delivery landscape which includes and not limited to Agile Applications Development, Support and Deployment.