Country Study Start-Up Specialist

Posted 02 August 2022
Salary Salary Competitive
LocationBelgium
Job type Full Time
DisciplineCRO & Clinical Operations
Contact NameLewis Joshi

Job description

​Mantell Associates are currently partnered with a leading mid-sized CRO with the most solid progression structure and management system we have ever seen within a CRO.

Are you looking to join a CRO with over 95% employee retention rates?

Would you like to see how you can achieve your career aspirations in a very short space of time with clear guidance from the outset?

The organisation we are currently partnered with are going from strength to strength, offering a management structure second to none and award winning. They have clear set career progression plans for employees base on the employees career aspirations and on top of all this allow for a impactful work-life balance.

Country Study Start Up Specialist

Support of the Reg Affairs Study Start-Up (RASSU) department:

  • Inform the RASSU department of any modifications to the country's submission procedures and drug laws.

  • Delivers final submission package to RASSU Specialist assigned to the research after reviewing/preparing local submission documentation and submitting to Ethics Committees and Competent Authority for Clinical Trials/RWE in compliance with local country norms.

  • Identify the Central and Local Ethics Committees and Competent Authority required for the study at the national level; process pre-payments to Ethics Committees and Competent Authority; and, in collaboration with the RASSU Specialist assigned to the study, adapt study-related documents (like informed consent forms) to meet each local country's requirements.

  • Serve as a clinical trial/RWE applicant, and serve as the primary POC for the ethics committees, competent authority, and RASSU Specialist assigned to the research on a national level.

  • Discuss EC/CA results in detail with the RASSU specialist assigned to the study.

Support the Legal Team:

  • Cultivate connections with important people in each location.

  • Contact between the site and CTI regarding the contract.

  • Help with site contract translation; keeping track of the progress by incorporating project-specific data into corporate databases, systems, and tracking tools (such as the Trial Interactive database).

  • Determine any particular investigator, national, or geographical difficulties, as well as any supplementary agreements that would be required.

  • Aid in the execution of the site contract.

Support Site Budget Activities:

  • Locate and build a connection with the site staff members in charge of budget proposals.

  • Locate and build a connection with the site staff members in charge of budget proposals.

  • Has thorough understanding of and expertise filling out site-specific budget templates.

  • Websites may learn about the templates and contents of budgets.

  • Recognize and inform budget managers for clinical trials of any modifications made by the site.

  • Assist with translation, update the Trial interactive database to track progress, share draughts and final versions with CTI staff, and provide site staff with the agreed-upon final budget.

Country Study Start Up Requirements

  • Ongoing interest in learning.

  • Detail Oriented.

  • The capacity to work successfully in a multinational team context.

  • Confidential

  • Strong experience and proficient user with Microsoft Office.

  • Superior Customer Service skills.

  • Able to prioritize, organize and manage multiple tasks.

  • Strong working knowledge of ICH standards, EU legislation, and national drug laws.

  • Outstanding verbal and written communication skills.

  • Fluent written and spoken in both Dutch and English.

  • 3-5 years' minimum experience in clinical research (pharmaceutical, site, or CRO service), as well as local regulatory experience.

  • A degree in a health-related discipline, such as nursing, pharmacy, or health science, or comparable relevant work experience.

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact Lewis Joshi on + 44 20 3854 7718 or lewis.joshi@mantellassociates.com