Senior Clinical Trial Manager / Clinical Program Manager

The Senior Clinical Trial Manager / Clinical Program Manager will have the primary

responsibility for operational aspects of Capnia’s clinical trials. The Company is

conducting / planning to conduct clinical trials in selected neurology and pulmonary / allergy indications.

Responsibilities

This position is responsible for managing the overall conduct of assigned clinical trials (i.e., recruitment of investigators, development of study related forms, sourcing study supplies, shipment of Investigational Products and study supplies to sites, etc.). In this position, all responsibilities will be conducted in accordance with applicable regulations, guidelines, and Company procedures. These responsibilities include, but are not limited to:

• Participates in the development and preparation of study-related documents including, but not limited to: Investigator’s Brochure, Protocols, Amendments, Study Manuals, Case Report Forms (CRF), CRF Completion Guidelines, Sample Patient Information Sheets / Informed Consent Forms, and Clinical Study Reports Participates in the selection and management of vendors for assigned clinical trials (i.e., data management/statistical analysis CRO, printing company of CRFs/subject diaries, etc.)
• Conducts Pre-Study Site, Initiation, Interim Monitoring, and Close Out visits and preparatation of visits reports
• Develops the study monitoring plan for assigned clinical trials
• Ensures timely site payments per contractual agreement with investigational sites
• Participates in the preparation of Investigational New Drug Exemptions (INDs), Clinical Trial Applications, New Drug Applications (NDAs), and/or other regulatory submissions, where applicable
• Participates in the development of SOPs and ensures compliance with SOPs and with appropriate regulatory requirements
• Management of independent contract CRAs for projects as required
• Willingness to travel consistent with project needs
• Performs other related duties as assigned by management

Requirements

• BA/BS in Pharmacology, Chemistry, Biology, Biochemistry, Nursing or related field
• Minimum 4 years experience in Clinical Research
• Strong working knowledge of ICH guidelines, Good Clinical Practices, and applicable regulations, and guidelines related to the clinical development of investigational products
• Experience in the development of clinical protocols and implementation of clinical trials for neurology and/or allergy products is desirable
• Experience in development of neurology and/or allergy products is desirable
• Excellent interpersonal and effective written and verbal communication skills
• Strong organizational skills and attention to detail, from initiation through completion of projects
• Ability to travel nationally and internationally

To apply, please email your resume to info@capnia.com.

No phone calls, please.