CEVA Specialist - DMC Lead

ob Family Description

Provides comprehensive safety services across the lifecycle of pharmaceutical compounds and medical devices, from first in human clinical trials through post-approval, marketed product, and regulatory safety requirements. Collects, tracks, and reports adverse events or clinical outcomes; analyzes and reports aggregate safety data; performs safety surveillance; and performs benefit-risk evaluation and planning.

Sub-FamilyDescription

Manages and implements clinical endpoint adjudication process and manages the data safety management boards during clinical trials.

Tracks clinical events; creates clinical event dossiers, submits dossiers, and corresponds with clinical experts; clinical event adjudication documentation; and hosts blinded and un-blinded clinical trial data safety reviews with external clinical experts and client representatives.

JOB OVERVIEW

Job Profile Summary

Provide management and service delivery excellence of (Clinical Event Validation and Adjudication) CEVA,OGM (Oversight Group Management) projects, as assigned by CEVA Management, covering single or multiple CEVA-OGM functions, with supervision from project oversight. Provide administrative coordination for Oversight Groups (Data Monitoring Committees, Safety Monitoring Committees and Steering/Advisory Boards) as assigned with minimal support. Provide leadership and accountability for all aspects of assigned projects.

Responsibilities

Essential Functions

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Manage customer interface and communication for assigned projects.Represent Clinical Event Abjudication (CEVA) on assigned projects as primary point of contact within CEVA for all internal and external customers. Liaise between internal/external customers inclusive of members.;

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Manage customer deliverables for assigned projects with minimal support. 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, as needed.

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Develop, finalize, and distribute all project-specific CEVA documents.

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Ensure compliance to IQVIA high quality standards and work within a matrix framework to achieve project and customer deliverables.

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Execute administrative tasks as required.

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Collaborate with CEVA Management to achieve departmental goals i.e. understand quality document management and assist in the achievement of productivity, quality, compliance, utilization, and realization metrics.

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Provide support 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.;

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Manage realization/profitability for assigned projects under guidance from CEVA project oversight. Work closely with CEVA project oversight to update financial systems, including revenue recognition, invoicing, forecasting, project budget review, project financial analysis, pursuit of change orders.

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Develop specialist expertise in aligned areas.

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• Attend meetings with internal and external stakeholders under guidance of CEVA Management as needed. Provide project status updates. Define processes, and project planning/strategy. Provide feedback to CEVA project oversight resource and Line manager on any challenges/issues and successes.;

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Drive business growth by improving customer loyalty through enhanced customer relations and service delivery excellence as guided by Line manager.

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Contribute in audits and inspections for assigned projects. Liaise with Quality Assurance staff and knowledge and quality management team in the compilation of Corrective and Preventive Action Plans.

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Upon sponsor customer approvals, locate and contract members and handle financial aspects. Onboard members and training them on roles and responsibilities.

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Perform project meeting management including logistics planning and conduct.

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Serve as back-up for other CEVA Specialists as assigned.

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Under the guidance of CEVA Management, establish mutually agreed upon working practices with customer, for standardized implementation across projects.

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Track and document project progress at all project phases (start-up, operations and close-out) and identify risks and develop mitigation plans.

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Work closely with CEVA project oversight and/or Line manager to address problem areas and customer needs.

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Read and acknowledge all necessary IQVIA standard operating procedures (SOPs), customer SOPs and e-Trainings as required.

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Ensure all required training is executed within a timelines and documented. Ensure individual training plan and training transcript reconcile.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Experience

Typically requires 0 - 2 years of prior relevant experience.

Knowledge

Requires knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education.

Education

Education Level

Education Details

Req

Pref

Bachelor's Degree

Nursing Degree or Bachelor's degree in life sciences or educational equivalent in health science or other directly related field and clinical trial knowledge; or equivalent combination of education, training, or experience.

X

Or

Additional Work Experience

Experience Details

Req

Pref

Equivalent combination of education, training and experience

X

1 years relevant experience

X

Skills and Abilities

Skill/Ability

Description

Proficiency

Working knowledge of Clinical Event Abjudication (CEVA) services. Familiarity with functionality of the Endpoint Tracking Database.

Basic knowledge of applicable global, regional, local clinical research regulatory requirements, i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, Standard Operating Procedures (SOPs).;

Ability to meet deadlines, manage competing priorities and changing demands.;

Sound organization and time management skills.

Ability to follow instructions/guidelines, work independently, and on own initiative.

Attentiveness to detail and accuracy and ability to maintain high quality standards.

Demonstrate effective IT skills.

Effective written and verbal communication skills.

Ability to be flexible and receptive to changing process demands.

Willingness and aptitude to learn new skills across CEVA service lines.

Ability to establish and maintain effective working relationships with co-workers, managers and clients.