Assoc CEVA Mgr
Provide management and service delivery excellence on a range of projects/programs 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.
- 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.
- 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 endpoint adjudication committee coordination, core laboratory coordination, DSMB administration, and steering committee administration.
- 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 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, including revenue recognition, invoicing, project budget review, project financial analysis, pursuit of change orders, etc.
- Actively participate 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, service delivery excellence and outstanding customer communication.
- Participate in sales activities such as sales presentations and proposal development (e.g., capabilities, bid defenses, strategy, costs and text) as required. Incorporate strategic options when defining project/program scope and processes with customer.
- Support customer relationship into partnership mode; manage accounts targeting extended business relationships throughout project lifecycle. Focus on customer loyalty and contract renewal.
- Work in a customer centric fashion analyzing customer needs and developing innovative, cross-functional strategic solutions within CEVA service lines to meet customer needs.
- Participate in audits and inspections for assigned projects. Liaise with Quality Assurance staff and management in the compilation of corrective action plans.
- Apply specialist expertise within the CEVA department.
- Provide historical perspective and input on clients and processes.
- Collaborate with other CEVA managers to address and resolve customer needs and issues.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- 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 negotiations in a matrix service delivery environment with shared accountabilities.
- Independent judgment, negotiating, decision-making, and problem solving skills.
- Effective business acumen and financial analytical skills, tactical planning, and budgeting.
- Cross trained in a minimum of two CEVA service lines.
- Ability to handle multiple projects with competing deadlines.
- Customer focused with effective relationship building skills.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree in health science or other directly related field and a minimum of 5 years of experience in CEVA (endpoints, DMC/DSMB, Core labs, Advisory boards); or equivalent combination of education, training, or experience.
Extensive use of keyboard requiring repetitive motion of fingers.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
Regular sitting for extended periods of time.
Requires domestic and occasional international travel.
EEO Minorities/Females/Protected Veterans/Disabled
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