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Study Start-Up Specialist

  • Location:

    Anderlecht, Belgium

  • Contact:

    Charlotte Evens

  • Job type:


  • Contact phone:

    +32 15 28 40 43

  • Industry:

    Life Sciences, Clinical Research

  • Contact email:

One of the best pharmaceutical companies in the world is looking for a Study Start-Up Specialist in combination with Country Project Management responsibilities. Are you a (lead) Clinical Research Associate and want to gain project management skills? Don't hesitate and apply today !

Job Description

The Study Start-up Specialist is responsible for all Study Start-Up related activities in the country/region, on assigned studies, overseeing and leading Study Start-Up activities in collaboration with other clinical research stakeholders.
The Country Study Specialist is responsible for providing project co-ordination and operational solutions to support Clinical Project Managers. The position also provides clinical trial oversight to local study teams to enable effective management of both global and local trials.


  • The Study Start-Up Specialist updates knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures
  • The Study Start-Up Specialist executes all start-up activities prior to site activation on assigned studies, according to standards and aligned with study/project requirements and timelines
  • The Study Start-Up Specialist prepares country level Informed Consent Form and obtains ethics committees' and local regulatory authorities' approval & prepares ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country
  • The Study Start-Up Specialist maintains and analyzes study start-up data (metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement
  • The Study Start-Up Specialist partners with Clinical Project Managers and Clinical Study Specialists to provide guidance on regulatory/ethics requirements, to track and drive site activations and trial amendments submissions, by regularly reviewing and monitoring status of submissions/activations
  • The Study Start-Up Specialist supports drug label preparation and approval (as local label representative) for studies in collaboration with local Regulatory/Quality department, as required
  • The Study Start-Up Specialist liaises and collaborates with relevant authorities/bodies to further enhance clinical trial process, government policies/ laws, via innovative approaches
  • The Study Start-Up Specialist submits, according to local regulatory requirements, all Suspected Unexpected Serious Adverse Reactions (SUSARs), Six Monthly SUSAR Reports (SSRs) and Development Safety Update Reports (DSURs)
  • In collaboration with Clinical Project Managers, the Study Start-Up Specialist identifies and tracks new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required
  • The Study Start-Up Specialist is responsible for study budget and contracts negotiation in collaboration with Contracts Manager/Associate, as required and ensures compliance with Fair Market Value in the country
  • The Study Start-Up Specialist coordinates/supports operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring quality and safety standards, regulations, timelines and budget commitments are met
  • The Study Start-Up Specialist performs/coordinates protocol and site level feasibility activities, including evaluation of patient population and final site selection (if applicable)
  • The Study Start-Up Specialist provides input into and/or develops study related materials such as Monitoring Plans, Recruitment Plans and Study Newsletters
  • The Study Start-Up Specialist supports/coordinates the negotiation of site budgets within Fair Market Value guidelines, budget plans and provides oversight for site payments per contract, as required


  • You hold a University degree, minimum Master in (Life)Sciences
  • You have minimum 3 years Clinical Research Associate (CRA) experience
  • Experience with Phase 1 or rare diseases is a big plus
  • You have demonstrated knowledge and understanding of clinical trials and experience in managing projects
  • You have demonstrated knowledge and understanding of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practices (ICH-GCP), as well as understanding of the regulatory, ethics and contractual requirements for starting clinical trials in the relevant country
  • Previous line management experience/supervision of staff is preferred
  • Previous experience managing projects is desirable
  • You are trilingual in Dutch, French & English (written and spoken)
  • You have good knowledge of Microsoft Office (Powerpoint, Excel, etc…)
  • You are a team player and have a flexible mind-set to take on other tasks
  • Existing right to work in Europe required


  • A full-time position with a permanent contract as a consultant via Oxford
  • A balanced salary package based on your experience and fringe benefits (company car, fuel card, insurances, 12 ADV, ...)
  • You will be able to work in one of the biggest pharma companies in Belgium
  • You will enter an environment where a good work-life balance is very important

Vacancy number: 18437