CEVA Manager - Adjudication Lead

Overview

PURPOSE

Provide oversight, management, and service delivery excellence of projects as assigned by CEVA (Clinical Event Validation and Adjudication) management, covering single or multiple CEVA functions. Provide leadership and accountability for all aspects of assigned CEVA projects, working 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, DSMB administration, and steering committee administration.

Collaborate with senior managers to implement strategic initiatives at the project, program, and department level to ensure global consistency.

• Manage customer interface and communication for assigned projects/programs. Represent CEVA on projects/programs as primary point of contact within CEVA for all internal and external customers; liaise between internal/external.

• Manage customer deliverables for assigned projects/programs. Tactical, day-to-day leadership at project/program level. Responsibilities include project planning (timelines, deliverables, resourcing, central filing, and archiving records), scope management, quality management and project financial management.

• Develop, finalize, and distribute all project-specific CEVA documents and design all necessary programmed reports and listings relevant to CEVA. Provide oversight guidance in this area to less experienced CEVA staff.

• Work closely with internal and / or external partners to manage development, testing, and use of electronic systems necessary for CEVA project processes.

• Develop and provide project-specific CEVA process training to CEVA team members, monitors, and investigative site personnel, as appropriate.

• Provide oversight, 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.

• Manage realization/profitability for assigned projects/programs. Update financial systems, revenue recognition, invoicing, project budget review, project financial analysis, pursuit of change orders, etc. Provide oversight guidance in this area to less experienced CEVA staff.

• Actively contribute at meetings with internal and external stakeholders. Provide project status updates, define processes, and project/planning strategy.

• Work with sales and proposals to ensure rapid, seamless, tailored responses to opportunities. Drive business growth by improving customer loyalty through enhanced customer relations and service delivery excellence.

• Facilitate sales activities, and sales presentations and proposal development (e.g., capabilities, bid defenses, strategy, costs, and text) as required.

• Develop customer relationship, into partnership mode; manage accounts targeting extended business relationship throughout lifecycle. Focus on customer loyalty and contract renewal. Facilitate discussions on new business opportunities with existing customers. Provide oversight guidance in this area to less experienced CEVA staff.

• Work in a customer centric fashion analyzing current and future customer needs and actively developing innovative, cross-functional strategic solutions within CEVA service lines to meet customer needs.

• Oversee audits and inspections for assigned projects and participating as required. Liaise with Quality Assurance staff and management in the compilation of corrective action plans. Provide oversight guidance in this area to less experienced CEVA staff.

• Apply specialist expertise within the CEVA department.

• Collaborate with other CEVA managers to resolve problem areas and customer needs ensuring global consistency.

• Works with CEVA management constructively in a matrix framework to achieve project and customers deliverables.

• In depth knowledge of applicable global, regional, and local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, Quintiles Standard Operating procedures (SOP).

• Working knowledge of CEVA service lines; willingness to increase knowledge across CEVA service lines and develop new skills.

• Excellent team management and leadership skills (e.g., motivational, conflict management, collaborative, organizational, and delegation).

• Strong project management skills (e.g., planning, organizational skills, strong presentation skills, report writing skills, and customer focus skills.

• Effective verbal and written communication skills including ability to network and lead teleconferences.

• Ability to establish and maintain effective working relationships with coworkers, managers, and customers.

• Ability to deliver on multiple projects and manage competing priorities.

• Ability to manage ambiguity.

• Effective business focus, marketing, and sales skills.

• Ability to achieve results through communication, facilitation, and…