This role serves as a Client Relations Executive (CRE) to oversee the business aspects of clinical operations, provide project management and business development assistance for the Medical Device and Diagnostics business unit to achieve target revenue and profitability. You will also ensure the contracted services and expectations of all projects are carried out by the project teams in accordance with executed contracts and Customers' expectations. Your duties will include management of staff, utilization and realization of project revenue for business unit (BU), analysis of financial data, assume the role of primary liaison with Customers, Vendors, Senior Management and Investigator sites as needed, and organize department hierarchy and processes to achieve targets. This may include line management responsibilities for project management and clinical staff within the business unit. You will also provide scientific expertise as needed.

JOB RESPONSIBILITIES
Essential Functions:

• You will provide oversight for Medical Device and Diagnostics Business Unit projects to ensure study launch, conduct and closeout occurs according to the Customer's and company's contractual agreement. You will ensure studies progress according to internal and Customer quality standards, SOPs, GCPs and ICH guidelines to fulfill all federal and local regulations.

• You will forecast, prioritize and direct staff to achieve on-time quality sponsor deliverables, contractual project requirements, utilization goals and profitable results.
• You will work with senior management and Business Development to set strategic direction for Business Unit to better target the types of projects across selected customer segments, you'll make recommendations, and drive the strategy execution for successful business growth.
• You will evaluate the progress of your Business Unit projects and assigned staff to ensure the meeting of targets for utilization, realization, and timelines.
• You will actively manage and mentor Project Management staff in leadership skills, customer management skills, project management skills, Trusted Process compliance, and for project specific tasks. You will ensure appropriate training and development is provided to all of your assigned staff.
• As necessary, you will troubleshoot difficulties which may arise in project conduct between the company and Customer, and/or between Clinical Development. You will facilitate team building and communication. You will act as a liaison and facilitator between other functional areas for overall operational issue.
• You will develop and maintains knowledge of current therapeutic/critical market environment and drug development trends as needed. You will facilitate team training in accordance with protocol and/or project requirements.

Other Responsibilities:

You will perform other work-related duties as assigned. Moderate travel may be required.You will have a Bachelor's degree in the life sciences, a nursing degree, or equivalent education plus extensive clinical research experience in a contract research organization, pharmaceutical, or biotechnology company. 10-15 years of clinical development experience is preferred, as is 5-7 yrs of progressive management experience. You will have spent some time actively managing clinical research projects across the Medical Device and Diagnostics functional area. Previous supervisory experience and pharma/CRO experience is required. You will have a thorough knowledge of FDA regulations, drug development, and clinical monitoring procedures. You will have demonstrated proficiency with ICH/GCP guidelines, a proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Your flexibility and the ability to mentor and manage new staff and to handle multiple tasks to meet deadlines delivering high quality work in a dynamic environment will be essential. Requires strong presentation, documentation and interpersonal skills as well as a team-oriented approach. Must have valid, current driver's license and ability to secure corporate credit card.

This job is not available to CO applicants