Hybrid
Full-Time
Bengaluru, Karnataka
India
About the Role
Role- Business Process Engineering (ClinOps)
Key responsibilities:
Responsible for analyzing, testing and documentation pertaining to Clinical Operation processes that support business needs using the Vault ClinOps suite (eTMF, CTMS, Payments, SiteConnect and Study Startup, Vault Connections)
Responsible for understanding of Veeva Trial Data & current state business processes, identifying pain points and gaps in process or system functionality as areas of opportunity
In-depth understanding of Clinical Operations process and how it impacts the key business processes regarding clinical study and trial changes, etc.
Formulate recommendations for improvement in business processes and system configuration, develop user requirements to facilitate solutions to achieve the business vision, and address key use cases.
Responsible for aligning with Customer and other project stakeholders for requirement gathering.
Responsible for understanding Process Models, creating User Story and User requirement creation
Experience in risk assessment creation for GxP and Non GxP systems.
Responsible for review of training material and for Training Delivery to end users.
Conduct Knowledge Transfer sessions for the implementation services
Facilitates URS & Process clarifications during and after roll-out
Responsible for User Consultation - Until Go-Live issues (End Users) are tracked, analyzed and solutions are proposed.
Strong analytical and problem-solving skills
Ability to influence and collaborate across different levels of stakeholders
CSV knowledge is preferred
Desired experience:
Experience working in ClinOps Vault (any of these modules: CTMS, TMF, Study Start-up, Site Connect)
Knowledge of Veeva Configurations (relevant to ClinOps)
Stakeholder management
Good Analytical Ability
Good Communication Skills
Preferable Experience:
Experience working in Product Teams and in Agile Projects
Understanding of GxP process Risk Assessment
CSV Experience
Key responsibilities:
Responsible for analyzing, testing and documentation pertaining to Clinical Operation processes that support business needs using the Vault ClinOps suite (eTMF, CTMS, Payments, SiteConnect and Study Startup, Vault Connections)
Responsible for understanding of Veeva Trial Data & current state business processes, identifying pain points and gaps in process or system functionality as areas of opportunity
In-depth understanding of Clinical Operations process and how it impacts the key business processes regarding clinical study and trial changes, etc.
Formulate recommendations for improvement in business processes and system configuration, develop user requirements to facilitate solutions to achieve the business vision, and address key use cases.
Responsible for aligning with Customer and other project stakeholders for requirement gathering.
Responsible for understanding Process Models, creating User Story and User requirement creation
Experience in risk assessment creation for GxP and Non GxP systems.
Responsible for review of training material and for Training Delivery to end users.
Conduct Knowledge Transfer sessions for the implementation services
Facilitates URS & Process clarifications during and after roll-out
Responsible for User Consultation - Until Go-Live issues (End Users) are tracked, analyzed and solutions are proposed.
Strong analytical and problem-solving skills
Ability to influence and collaborate across different levels of stakeholders
CSV knowledge is preferred
Desired experience:
Experience working in ClinOps Vault (any of these modules: CTMS, TMF, Study Start-up, Site Connect)
Knowledge of Veeva Configurations (relevant to ClinOps)
Stakeholder management
Good Analytical Ability
Good Communication Skills
Preferable Experience:
Experience working in Product Teams and in Agile Projects
Understanding of GxP process Risk Assessment
CSV Experience