Clinical Data Manager
Cognizant provides consulting services to clients for various business segments and across geographies. Cognizant is oriented to provide roadmap and enhance client value proposition to address business issues, deriving enhanced value optimization and effectiveness.
o General: to Lead and Manage project activities at Study level from onsite for Clinical Data Management and ensure efficient coordination among Study Teams and Data Management Teams.
o Act as a single point of contact for all data management center deliverables during the Study Set-up, conduct and close-out phases
o Creation of the Case Report Form from global standards and creation of protocol specific case report form modules by coordinating with sponsor's protocol team and review of the same
o Accountable for database review, testing and UAT of edit checks specifications for assigned studies
o Responsible for Project Management of the study and accountable for all study deliverables from end to end.
o Clarify, manage and successfully implement customer expectations, resolving conflicts whilst pursuing win-win scenarios; Manage relationships with Client.
o Monitor quality and efficiency across functions to identify trends and opportunities for improvements. Ensure sharing of learning across geographies
o Support both protocol and procedural training to external vendors and investigator's site whenever required
o Be the champion 'Change Management' agent from Cognizant, work with the sponsor study teams to implement new processes and liaise between the sponsor
o Proven experience in Clinical data management processes.
o Experience in ICH- GCP and applicable regulatory guidelines.
o Understanding of drug development process, clinical trial methodology, and medical terminology.
o Good technical and problem solving skills.
o Good organizational, planning and project management skills.
o Good negotiation and presentation skills.
o Attention to details and quality focused.
Cognizant (NASDAQ: CTSH) is a leading provider of information technology, consulting, and business process services, dedicated to helping the world's leading companies build stronger businesses. Headquartered in Teaneck, New Jersey (U.S.), Cognizant combines a passion for client satisfaction, technology innovation, deep industry and business process expertise, and a global, collaborative workforce that embodies the future of work. With over 100 development and delivery centers worldwide and approximately 233,000 employees as of March 31, 2016, Cognizant is a member of the NASDAQ-100, the S&P 500, the Forbes Global 2000, and the Fortune 500 and is ranked among the top performing and fastest growing companies in the world. Visit us online at www.cognizant.com or follow us on Twitter: Cognizant.