Shiny Amalia Vincent
Mannheim
Summary
A functional expert in Clinical domain with 15+ years of experience in Clinical Data Management, Life Sciences Consulting, Project and People Management providing Subject matter expertise on multiple clinical systems, vendor management and processes for Pharma customers alongside managing client relationship, operational management and managing globally dispersed teams.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Senior Manager, Projects
Cognizant Technology Solutions
01.2024 - Current
- Managing project and clients, ensuring deadlines and budget targets are met.
- Coordinating with stakeholders to ensure successful delivery of projects on time and within budget.
- Act as Gen AI POC for LifeSciences collecting and driving use cases solutioning and presenting built solutions to clients
- Conduct regular performance reviews of all team members
- Create detailed reports outlining progress, budgeting, timelines, deliverables.
- Work on RFI, RFPs and attend industry conferences and meetings.
Manager-Projects
Cognizant Technology Solutions (Client: Abbvie)
Frankfurt
01.2021 - 12.2023
- Own Program management, be a highly effective liaison between the global development teams, site users, clinical study teams, IT teams and vendors and participate in BID defense meetings
- Perform requirements gathering, feasibility analysis, estimate efforts, track project schedules, and manage vendor partners
- Create process documents with understanding of regulations like ICH GCP, 21 CFR Part 11, HIPAA 21
- Manage contracts, SOP's, negotiate timeliness, finances and costs and track quality and performance metrics
- Propose solutions to optimize decisions, track metrics and attend vendor oversight, executive steering committee meetings
- Handle engagements from Conceptualization, Budgeting, Program Planning, Change Management support, Execution strategy and Engagement implementation
- Support creation of study specifications and help with study designing in various EDC and IRT systems
Senior Associate-Projects
Cognizant Technology Solutions (Client: Abbvie, Allergan)
Frankfurt
12.2017 - 12.2020
- Perform data change requests and production support to enable subjects continue getting drugs to participate in the clinical trials
- Provide requirements for IRT solutions roadmap and support Randomization, Unblinding and Supply management requirements
- Build and manage EDC studies and amendments and provide guidance on using Lab Administration, Medidata Coder, TSDV, own Core Configuration setup and updates to Global Library
- Manage the EDC and IRT study setup team with direct reportees and conduct performance evaluations
- Perform risk analysis of project and work with compliance teams and record CAPAs
- Collaborate with cross functional groups to define standards to be used in the design and development of key system interfaces.
Senior Associate-Projects
Cognizant Technology Solutions (Client: Abbvie)
Chennai
09.2017 - 11.2017
- Create training materials and deliver training to clients for studies to the systems that are implemented in IRT and EDC
- Record and track defects and manage program and defect metrics
- Demonstrate proof-of-concept/solution built to the business users, conduct user training and support DB lock and data archival
- Ability to translate strategy into successful business and technical capabilities and great customer relationship management
- Create test scripts and test report documentation to enable production release of studies.
Senior Associate-Projects
Cognizant Technology Solutions (Client: Abbvie)
Waukegan
06.2014 - 08.2017
- Build clinical studies and implement the clinical data collection requirements in the IRT and EDC systems
- Work on IRT systems integration with external systems such as EDC, SmartSupplies, ePRO, CTMS etc
- Address project maintenance issues/questions from the client teams and participate in regulatory body audits
- Manage the Rave Global Library and work with the standards team and update it as per CDASH requirements
- Provide subject matter expertise and place studies within the client's IRT and EDC solutions.
Associate-Projects
Cognizant Technology Solutions (Clients: AstraZeneca, Sanofi, Servier)
Chennai
01.2009 - 05.2014
- Design and Develop eCRF's and validations in Medidata Rave, write test scripts and perform unit testing of the same
- Develop clinical studies in the IRT system BioClinica Trident
- Collect requirements and create design for building automation tools to fasten clinical study build
- Lead Programmer to develop systems to capture clinical data, develop reports and integrations, own and implement new features such as TSDV, Coder, Patient Dashboard and implement imedidata
- Interact with the project teams to organize timelines, responsibilities and deliverables.
Education
Bachelor of Technology (BioTechnology) -
Sathyabama University
Skills
- EDC
- RTSM
- Clinical Study Build
- SDLC
- People Mangement
- Clinical Data Management
- Client Relationship
- Requirements Gathering
- Vendor Management
- Product Roadmap
- Business Development
- User Training
- Process Streamlining
- EPRO
- Contracts, Revenue Management
- Life Sciences Domain Consulting
- EDC Medidata Rave
- Oracle Clinical One
- IRT BioClinica RTSM
- Medidata RTSM
- Endpoint
- Cenduit
- Veeva EDC
- RFI, RFP
Certification
- Medidata Certified Rave Train the Trainer
- Medidata Rave Study Builder and Study Administrator
- Veeva EDC Certified
Personal Information
Title: Project Manager, Clinical Data Management
Timeline
Senior Manager, Projects
Cognizant Technology Solutions
01.2024 - Current
Manager-Projects
Cognizant Technology Solutions (Client: Abbvie)
01.2021 - 12.2023
Senior Associate-Projects
Cognizant Technology Solutions (Client: Abbvie, Allergan)
12.2017 - 12.2020
Senior Associate-Projects
Cognizant Technology Solutions (Client: Abbvie)
09.2017 - 11.2017
Senior Associate-Projects
Cognizant Technology Solutions (Client: Abbvie)
06.2014 - 08.2017
Associate-Projects
Cognizant Technology Solutions (Clients: AstraZeneca, Sanofi, Servier)
01.2009 - 05.2014
Bachelor of Technology (BioTechnology) -
Sathyabama University
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