Act as a liaison with sponsor to oversee clinical studies to include:

· Ensure study remains within scope and out of scope activities are identified and handled as appropriate

· Perform risk management and contingency planning activities to ensure that all potential study risks, such as delays in study milestones and increased study costs, are managed in a proactive and efficient manner

· Facilitate team coordination and work flow for projects

· Develop and Monitor project timelines and resources allocated

· Communicate up-to-date information regarding project progress to all relevant interested parties

· Provide strategic input on enrollment and contingency planning

· Vendor management to include procurement and negotiation of contracts

· Lead project team meetings to ensure on-time deliverables

· Assist in protocol development and CRF design

· Track departmental carbon footprint and implement policies, procedures, and practices to decrease negative impact on the environment

· Ensure all departmental purchases and practices reflect the company’s corporate citizenship policy

· May manage clinical study budget and contracts

· Knowledge of FDA and International Conference of Harmonization and Good Clinical Practices (ICH/GCP) Guidelines

· Excellent written and verbal communication skills and detail-oriented skills

· Various computer skills – Excel, Word, PowerPoint, Microsoft Outlook

· Extensive understanding of principles, concepts, practices, and standards of clinical research

· Excellent leadership skills

· Excellent organizational skills, including the ability to handle multiple assignments

· Possess full working knowledge of all required clinical study tasks and elements from study initiation through completion

· Ability to ensure a good customer relationship is established and maintained

EDUCATION REQUIREMENTS:

· Bachelors Degree in science/health related field required

· 4-6 years of clinical experience in the pharmaceutical/CRO industry