Specialist Study Start Up & Regulatory Affairs

The Specialist Study Start Up and Regulatory is responsible for completing study start-up and regulatory deliverables based on an established SSU  RA management plan. They also serve as a liaison between SSU/regulatory project team authorities vendors and investigative sites in the planning organizing and executing SSU and regulatory deliverables following project corporate and industry regulatory strategies.        

• Under guidance of senior team members independently manages study start-up activities for projects of low complexity ensuring effective coordination and delivery of assigned.
• Prepare collect review regulatory information to support submissions to national authorities and ECs/IRBs for initial authorisation and maintenance in compliance with the applicable regulations.
• Collect review for completeness and compliance and track essential documents for Study Start-Up to facilitate efficient site initiation and activation. Investigate incomplete inaccurate or missing documents to ensure accuracy and completeness of information. Prepare study team reports or updates regarding status of essential document collection review and approval.
• Responsible for drafting negotiating finalizing and executing clinical site agreements ancillary agreements as well as amendments at country or regional level in accordance with project requirements and country regulations and within the projected delivery timelines.
• Responsible for site outreach in assigned country/countries; point of contact for site sharing of non-confidential and confidential study information and management of confidential disclosure agreements
• Coordinate with study teams sponsors clinical monitoring clinical contracts and/or other functional areas on the priority and processing of documents leading to site activation readiness investigational product release site activation and site initiation.
• Review all relevant documentation e.g. labels patient information sheets diary cards insurance etc to ensure compliance with ICH GCP & country specific requirements
• Arrange for and/or review translation of essential documents as required
• Contributes to the development of regulatory and study start-up strategies and supports preparation of SSU plans and related documentation
• Ensure timely and accurate completion of project trackers filing in study portal and TMF and QC of submission dossiers
• Ensures assigned deliverables are completed in accordance with project timelines and expectations.
• Ensure all relevant essential documents are submitted to Trial Master File (TMF) in a timely manner as defined by SOPs and study-specific requirements.

Qualifications :

• Graduate degree in Chemistry or Life Sciences Pharmacy MD or equivalent combination of education and experience
• Previous experience within the pharmaceutical/CRO industry 
• Good knowledge of ICH GCP and national regulations for territories of competency
• Good written and verbal communication skills to clearly and concisely present information
• Proficiency in English both written and verbal 

Remote Work :

Yes

Employment Type :

Full-time