Regulatory and Site Start-Up Specialist

Role Overview

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines.
• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead.
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities.
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.
• Partner with the assigned site CRA to ensure alignment in communication for site review and management of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Form.
• Responsible for/facilitates the translation and co-ordination of translations for documents.
• Maintain communication with other key functions participating to country start up.
• Act as SME for collection and maintenance of site level critical path to Site Activation data points.
• Participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM.
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans.

Requirements

• Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline)
• Registered Nurse (RN) or equivalent combination of education, training, and experience.
• A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial.
• 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• Strong communication and organizational skills.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English.

Benefits

• Health insurance
• 401(k) matching
• Paid time off
• Professional development opportunities