TFS HealthScience is excited to be expanding our Study Start Up team
and we are looking for an experienced, highly motivated Study Start Up Specialist (SSU Sp)
who shares our vision of providing clinical research excellence. Our Study Start Up team is a highly experienced international group of professionals led by an industry expert.
We are a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach only a mid-size CRO can deliver.
Our cores values of Trust, Quality, Flexibility and Passion are what makes 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.
TFS HealthScience is looking for a Study Start Up Specialist (SSU Sp) home or office based in Germany
. We look forward to receiving your application!
The Study Start Up Specialist (SSU Sp)
is part of 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 (SSU Sp)
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.
- Performs the startup activities of assigned studies within a country or region ensuring that those are performed on-time, 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.
- Bachelor’s Degree preferred
- Good knowledge of GCP/ICH guidelines
- Good Knowledge of applicable regulatory requirements, SOPs and company’s Corporate Standards
- Minimum 1-3 years of relevant clinical experience
- Previous experience with investigator start-up documents and investigative sites is preferred
- Good written and communication skills
- Good organizational skills and experience working with cross functional teams
- Strong software and computer skills
- Capable of multi-tasking 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 can we offer you?
A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients. Benefits include:
- Entrusted work time
- Corporate Pension Plan
- Global General Liability Insurance
- Global Travel Insurance