About Us:
Cognizant (Nasdaq: CTSH) engineers' modern businesses. We help our clients modernize technology, reimagine processes and transform experiences so they can stay ahead in our fast-changing world. Together, we're improving everyday life. See how at www.cognizant.com
The role is encouraged to drive technology discussions and analyze the current landscape for gaps in addressing business needs. Cognizant needs a motivated individual to challenge the status quo and provide thought leadership/standard methodologies to improve our current services and technologies.
Role: Sr. System Support Analyst – Medidata CTMS
Job Summary
We are seeking a highly experienced resource with a strong background in Medidata Rave. The ideal candidate will have 12 to 15 years of experience and will be responsible for providing expert guidance and support to our clients. This role requires a deep understanding of clinical data management and the ability to drive successful outcomes for our customers.
Description and Responsibilities:
Serve as System Administrator of Medidata CTMS and Commercial off-the-shelf (COTS) Software.
Maintain systems that are fully compliant with ICH GCP and regulatory guidelines including 21 CFR Part 11.
Partner with system vendors to implement system upgrades and enhancements. Perform evaluations/testing of version upgrades to ensure that the upgrade does not impact current data held within the software is accessible to users and outputs from the software are as expected.
Perform User Acceptance Testing (UAT) as needed in a risk-based approach with a focus on the unique aspects of each release to ensure that the system meets the intended use.
Advocate for system updates and modifications with the service provider as needed based on personal system usage and through end-user feedback.
Maintain proper system documentation (e.g. Release Notes Validation Testing Plan Validation Reports Validation Certificate) as applicable and provide for filing within TD2 Quality Assurance. Monitor system performance identify and implement system and process improvements based on end-user feedback.
Create and maintain system SOPs Working Guidelines and training materials.
Conduct CTMS and training for all team members including employees' contractors' consultants and Sponsors.
Maintain trial CTMS documents and training certificates for inclusion in the Trial Master File (TMF).
Required Qualifications
Bachelor's or master's degree in science or related discipline
Strong knowledge on experience in Clinical Systems like EDC, CTMS and eTMF
Hands-on experience in Medidata CTMS
System admin and end-user support experience
Knowledge on GxP compliance and 21CRF Part11
Knowledge on multiple therapeutic area
Applications will be accepted until October 15th, 2024.
Salary and Other Compensation:
The annual salary for this position is between $66,896 to $113,000 depending on experience and other qualifications of the successful candidate.
This position is also eligible for Cognizant’s discretionary annual incentive program, based on performance and subject to the terms of Cognizant’s applicable plans.
Benefits: Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:
Medical/Dental/Vision/Life Insurance
Paid holidays plus Paid Time Off
401(k) plan and contributions
Long-term/Short-term Disability
Paid Parental Leave
Employee Stock Purchase Plan
Disclaimer: The salary, other compensation, and benefits information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
The Cognizant community:
We are a high caliber team who appreciate and support one another. Our people uphold an energetic, collaborative and inclusive workplace where everyone can thrive.
About us:
Cognizant (Nasdaq-100: CTSH) is one of the world's leading professional services companies, helping organizations modernize technology, reimagine processes and transform experiences so they stay ahead in a fast-changing world.
Our commitment to diversity and inclusion:
Cognizant is an equal opportunity employer that embraces diversity, champions equity and values inclusion. We are dedicated to nurturing a community where everyone feels heard, accepted and welcome. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other protected characteristic as outlined by federal, state or local laws.
Disclaimer:
Compensation information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.