Description

Knowledge:
Excellent interpersonal skills, and demonstrated ability to lead is required.
Experience in managing staff as well as mentoring and developing junior staff is required.
Strong communication and influence skills and ability to create a clear sense of direction is necessary.
Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials.
Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required.
Experience in developing RFPs and selection and management of CROs/vendors.
Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents (e.g. IND, NDA, etc.) with little supervision.
Ability to examine functiona...