Senior CEVA Specialist
IQVIA Holdings Inc.
Primary Location: Bratislava, Slovakia
Additonal Locations: Belgrade, Serbia,SRB; Belgrade, Serbia,SRB; Bratislava, Slovakia,SVK
As a you will provide management and service delivery excellence of projects, as assigned by Clinical Event Validation and Adjudication (CEVA) management, covering single or multiple EAM (Endpoint Adjudication Management) and OGM (Oversight Group Management) projects.Main Responsibilities:Provide leadership and accountability for all aspects of assigned CEVA projects.
Work cross-functionally and across the opportunity lifecycle, integrating delivery into one seamless and transparent program for customers in areas of Endpoint Adjudication Committee coordination, Core Laboratory coordination, Image Review Committee coordination, Data Monitoring Committee administration, and other, where relevant.
Lead oversight committees as required per customer. Manage customer interface and communication for assigned projects.
Ensure tactical, day-to-day leadership at project level. Responsibilities include project planning (i.e., timelines, deliverables, central filing, and archiving records), defining project/scope management, quality management, and project financial management under guidance of CEVA Management.
Provide project status updates, define processes, and project planning with support and guidance where relevant. Provide feedback to CEVA oversight and line manager on any challenges/issues and successes.
Develop and distribute all project-specific CEVA documents and design all necessary programmed reports relevant to CEVA, with support and guidance where relevant.
Provide project-specific CEVA process training to CEVA team members, monitors, and investigative site personnel.
Upon customer approvals, locate and contract committee members. Onboard committee members and train them on their roles and responsibilities.
Manage realization/profitability and revenue recognition for assigned projects. Responsible for updating financial systems, invoicing, forecasting project budget review, project financial analysis, pursuit of change orders).
Provide leadership and structure for customer service interface from scoping stage, through proposal generation, bid defense to service delivery, and throughout the development and commercial lifecycle of the product with support and guidance where relevant.
Serve as a Subject Matter Expert (SME) and provide guidance on focused areas and regulatory requirements as it relates to, where relevant.
Participate in sales activities such as sales presentations and proposal development.
Contribute during audits and inspections for assigned projects.
Required Skills and Qualifications:Bachelor's degree in life sciences or educational equivalent in health science or other directly related field.
Clinical trial knowledge or equivalent combination of education, training, or experience.5 years of prior work experience in Clinical Research
In depth knowledge of applicable global, regional and local clinical research regulatory requirement, i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Excellent written and verbal skills in English (min. C1).
Strong prioritization, planning and organizational skills.Effective verbal and written communication skills including ability to work and lead teleconferences.
Ability to manage ambiguity.
Strong presentation (independently present at internal/external meetings) skills, report writing skills and customer focus skills.
Accountability, ownership and transparency.
Demonstrates independent judgment, negotiating, decision-making, and problem-solving skills.
Business acumen and financial analytical skills, tactical planning, and budgeting.
Ability to handle multiple projects with competing deadlines.
Ability to establish and maintain effective working relationships with co-workers, managers, and customers.
Main Responsibilities:Provide leadership and accountability for all aspects of assigned CEVA projects.
Work cross-functionally and across the opportunity lifecycle, integrating delivery into one seamless and transparent program for customers in areas of Endpoint Adjudication Committee coordination, Core Laboratory coordination, Image Review Committee coordination, Data Monitoring Committee administration, and other, where relevant.
Lead oversight committees as required per customer. Manage customer interface and communication for assigned projects.
Ensure tactical, day-to-day leadership at project level. Responsibilities include project planning (i.e., timelines, deliverables, central filing, and archiving records), defining project/scope management, quality management, and project financial management under guidance of CEVA Management.
Provide project status updates, define processes, and project planning with support and guidance where relevant. Provide feedback to CEVA oversight and line manager on any challenges/issues and successes.
Develop and distribute all project-specific CEVA documents and design all necessary programmed reports relevant to CEVA, with support and guidance where relevant.
Provide project-specific CEVA process training to CEVA team members, monitors, and investigative site personnel.
Upon customer approvals, locate and contract committee members. Onboard committee members and train them on their roles and responsibilities.
Manage realization/profitability and revenue recognition for assigned projects. Responsible for updating financial systems, invoicing, forecasting project budget review, project financial analysis, pursuit of change orders).
Provide leadership and structure for customer service interface from scoping stage, through proposal generation, bid defense to service delivery, and throughout the development and commercial lifecycle of the product with support and guidance where relevant.
Serve as a Subject Matter Expert (SME) and provide guidance on focused areas and regulatory requirements as it relates to, where relevant.
Participate in sales activities such as sales presentations and proposal development.
Contribute during audits and inspections for assigned projects.
Required Skills and Qualifications:Bachelor's degree in life sciences or educational equivalent in health science or other directly related field.
Clinical trial knowledge or equivalent combination of education, training, or experience.5 years of prior work experience in Clinical Research
In depth knowledge of applicable global, regional and local clinical research regulatory requirement, i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Excellent written and verbal skills in English (min. C1).
Strong prioritization, planning and organizational skills.Effective verbal and written communication skills including ability to work and lead teleconferences.
Ability to manage ambiguity.
Strong presentation (independently present at internal/external meetings) skills, report writing skills and customer focus skills.
Accountability, ownership and transparency.
Demonstrates independent judgment, negotiating, decision-making, and problem-solving skills.
Business acumen and financial analytical skills, tactical planning, and budgeting.
Ability to handle multiple projects with competing deadlines.
Ability to establish and maintain effective working relationships with co-workers, managers, and customers.
Main Responsibilities:Provide leadership and accountability for all aspects of assigned CEVA projects.
Work cross-functionally and across the opportunity lifecycle, integrating delivery into one seamless and transparent program for customers in areas of Endpoint Adjudication Committee coordination, Core Laboratory coordination, Image Review Committee coordination, Data Monitoring Committee administration, and other, where relevant.
Lead oversight committees as required per customer. Manage customer interface and communication for assigned projects.
Ensure tactical, day-to-day leadership at project level. Responsibilities include project planning (i.e., timelines, deliverables, central filing, and archiving records), defining project/scope management, quality management, and project financial management under guidance of CEVA Management.
Provide project status updates, define processes, and project planning with support and guidance where relevant. Provide feedback to CEVA oversight and line manager on any challenges/issues and successes.
Develop and distribute all project-specific CEVA documents and design all necessary programmed reports relevant to CEVA, with support and guidance where relevant.
Provide project-specific CEVA process training to CEVA team members, monitors, and investigative site personnel.
Upon customer approvals, locate and contract committee members. Onboard committee members and train them on their roles and responsibilities.
Manage realization/profitability and revenue recognition for assigned projects. Responsible for updating financial systems, invoicing, forecasting project budget review, project financial analysis, pursuit of change orders).
Provide leadership and structure for customer service interface from scoping stage, through proposal generation, bid defense to service delivery, and throughout the development and commercial lifecycle of the product with support and guidance where relevant.
Serve as a Subject Matter Expert (SME) and provide guidance on focused areas and regulatory requirements as it relates to, where relevant.
Participate in sales activities such as sales presentations and proposal development.
Contribute during audits and inspections for assigned projects.
Required Skills and Qualifications:Bachelor's degree in life sciences or educational equivalent in health science or other directly related field.
Clinical trial knowledge or equivalent combination of education, training, or experience.5 years of prior work experience in Clinical Research
In depth knowledge of applicable global, regional and local clinical research regulatory requirement, i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Excellent written and verbal skills in English (min. C1).
Strong prioritization, planning and organizational skills.Effective verbal and written communication skills including ability to work and lead teleconferences.
Ability to manage ambiguity.
Strong presentation (independently present at internal/external meetings) skills, report writing skills and customer focus skills.
Accountability, ownership and transparency.
Demonstrates independent judgment, negotiating, decision-making, and problem-solving skills.
Business acumen and financial analytical skills, tactical planning, and budgeting.
Ability to handle multiple projects with competing deadlines.
Ability to establish and maintain effective working relationships with co-workers, managers, and customers.
Provide leadership and accountability for all aspects of assigned CEVA projects.
Work cross-functionally and across the opportunity lifecycle, integrating delivery into one seamless and transparent program for customers in areas of Endpoint Adjudication Committee coordination, Core Laboratory coordination, Image Review Committee coordination, Data Monitoring Committee administration, and other, where relevant.
Lead oversight committees as required per customer. Manage customer interface and communication for assigned projects.
Ensure tactical, day-to-day leadership at project level. Responsibilities include project planning (i.e., timelines, deliverables, central filing, and archiving records), defining project/scope management, quality management, and project financial management under guidance of CEVA Management.
Provide project status updates, define processes, and project planning with support and guidance where relevant. Provide feedback to CEVA oversight and line manager on any challenges/issues and successes.
Develop and distribute all project-specific CEVA documents and design all necessary programmed reports relevant to CEVA, with support and guidance where relevant.
Provide project-specific CEVA process training to CEVA team members, monitors, and investigative site personnel.
Upon customer approvals, locate and contract committee members. Onboard committee members and train them on their roles and responsibilities.
Manage realization/profitability and revenue recognition for assigned projects. Responsible for updating financial systems, invoicing, forecasting project budget review, project financial analysis, pursuit of change orders).
Provide leadership and structure for customer service interface from scoping stage, through proposal generation, bid defense to service delivery, and throughout the development and commercial lifecycle of the product with support and guidance where relevant.
Serve as a Subject Matter Expert (SME) and provide guidance on focused areas and regulatory requirements as it relates to, where relevant.
Participate in sales activities such as sales presentations and proposal development.
Contribute during audits and inspections for assigned projects.
Required Skills and Qualifications:Bachelor's degree in life sciences or educational equivalent in health science or other directly related field.
Clinical trial knowledge or equivalent combination of education, training, or experience.5 years of prior work experience in Clinical Research
In depth knowledge of applicable global, regional and local clinical research regulatory requirement, i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Excellent written and verbal skills in English (min. C1).
Strong prioritization, planning and organizational skills.Effective verbal and written communication skills including ability to work and lead teleconferences.
Ability to manage ambiguity.
Strong presentation (independently present at internal/external meetings) skills, report writing skills and customer focus skills.
Accountability, ownership and transparency.
Demonstrates independent judgment, negotiating, decision-making, and problem-solving skills.
Business acumen and financial analytical skills, tactical planning, and budgeting.
Ability to handle multiple projects with competing deadlines.
Ability to establish and maintain effective working relationships with co-workers, managers, and customers.
Bachelor's degree in life sciences or educational equivalent in health science or other directly related field.
Clinical trial knowledge or equivalent combination of education, training, or experience.5 years of prior work experience in Clinical Research
In depth knowledge of applicable global, regional and local clinical research regulatory requirement, i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Excellent written and verbal skills in English (min. C1).
Strong prioritization, planning and organizational skills.Effective verbal and written communication skills including ability to work and lead teleconferences.
Ability to manage ambiguity.
Strong presentation (independently present at internal/external meetings) skills, report writing skills and customer focus skills.
Accountability, ownership and transparency.
Demonstrates independent judgment, negotiating, decision-making, and problem-solving skills.
Business acumen and financial analytical skills, tactical planning, and budgeting.
Ability to handle multiple projects with competing deadlines.
Ability to establish and maintain effective working relationships with co-workers, managers, and customers.
Job posted: 2023-11-09
