Director Clinical Affairs

Job Title:

Clinical Affairs Director

Job Description

Manage all company clinical studies according to GCP and company goals. Overall responsibility for study progress from site set-up and initiation until closure.

Department:

Clinical Affairs

Reports to:

CEO

Responsibilities

Planning and ongoing management of all aspects of the clinical study according to GCP and company goals, as follows:

·      Establishing clinical trial documents including study protocol and clinical trial procedures

·      Preparation of clinical documentation for study application in accordance with territory specific requirements

·      Support in sites selection.

·      Sites set-up and study qualification and initiation

·      Support of clinical procedures as the leading clinical affairs person on-site on behalf of LuSeed.

·      Point of contact with site teams, including investigator

·      Point of contact with CRO, CRA, study coordinators and core-lab.

·      Assure study progress according to GCP with specific focus on patients’ enrollment and data collection.

·      Training and guidance through procedure

·      Support study monitoring - for data collection and maintenance – CRF, EDC procedural information, imaging.

·      Safety aspects – reporting, safety monitor process, interim analysis

·      Maintenance of study files

Job Requirements

Required Experience

At minimum 10 years of experience in running clinical trials and managing clinical sites as CRA/study manager in the medical device arena, with strong preference to class iii neurovascular or cardiovascular fields.

Required Knowledge and Education

·    Life Science degree

·    GCP and/or CRA course

·    Medical Background (RN etc.) – strong advantage

Additional Skills and requirements

·    Readiness to travel abroad

·    Fluent level of verbal English and technical writing in English

·    Good computer skills (office program)

·    Independence and flexibility

·    Good communication skills