Study Start-Up Specialist

TFS HealthScience is a leading global midsize Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full servicecapabilities resourcing and Functional Service (FSP) solutions.

Join Our Team as a Study Start Up Specialist home based in the Netherlands.

About this role

As part of our Study Start Up team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Study Start Up Specialist is part of the Site Management and Start Up Unit within TFS Develop and will function operationally as a member of a Project Team being responsible of startup activities according to company policies SOPs and regulatory requirements in addition to financial and contractual obligations.

The Study Start Up Specialist must contribute to ensure the planned start up plan is executed maximizing the recruitment window of assigned studies. As part of the job function will perform activities associated with feasibility and site identification study site initiation process interact with Ethics Committees or deal with investigator contracts.

Key Responsibilities:

• Performs the startup activities of assigned studies within a country or region ensuring that those are performed ontime within the scope and in compliance with ICH/GCP guidelines SOPs and protocol requirements.
• Collect review approve process and track regulatory & investigator documents required for study site activation.
• Prepare and complete regulatory process (IEC/IRBs) including ask for requirements to the EC/IRBSs prepare and collecting specific documentation submission and amendments regulatory fees.
• Collaborate with Regulatory department regarding HA/CA submission/notification.
• Main responsible of ensuring the quality control of documentation included in any submission/notification.
• Adapt Informed Consent documents according to local law and document the process following guidelines and SOPs.
• Ensure contracts are fully executed regulatory documents and approvals are granted IP Release authorized and specific project deliverables are completed.

Qualifications:

• Bachelors Degree preferred
• Good knowledge of GCP/ICH guidelines
• Good Knowledge of applicable regulatory requirements SOPs and companys Corporate Standards
• Minimum 13 years of relevant clinical experience
• Previous experience with investigator startup documents and investigative sites is preferred
• Good written and communication skills in English and Dutch
• Good organizational skills and experience working with cross functional teams
• Strong software and computer skills
• Capable of multitasking and working well under pressure to meet deadline coupled with a good understanding of working in a team environment
• Travel within this position is limited

What We Offer

We provide a competitive compensation package comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. Youll be joining a team that values collaboration innovation and making a difference in the lives of patients

A Bit More About Us

Our journey began over 25 years ago in Sweden in the city of Lund. As a global CRO with the ultimate goal of ensuring patients safety and wellbeing we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe North America Asia Pacific and the Middle East.

Our core values of Trust Quality Flexibility and Passion are what make TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization.

#Together we make a difference