Freelance SSU and Regulatory Specialist Germany
- Experience Level
- Experienced (non-manager)
Here at Syneos Health we are currently recruiting for a Study Start-Up & Regulatory Specialist – Freelance position for 6 months to be home based in Germany. Within this role you’ll be responsible to cover submissions for your assigned studies across the DACH region:
Conduct research and maintain proficiency of local requirements for documentation of IRB/EC and Regulatory Authority submission approvals, and subsequent follow-up documentation and providing updates of local processes and requirements to the Regulatory Intelligence portal.
Liaise with study sites regarding essential document collection and assisting with IRB/EC submissions.
Compile and submit CTAs to Regulatory Authorities and IRB/EC (if applicable).
Complete review of CTAs prior to submission to Regulatory Authorities and IRB/EC as part of internal QC process.
Customize country/site specific Patient Information Sheet and Informed Consent Forms and reviewing study documents.
Complete review of essential documents following Essential Document Checklist QC.
Review translations of regulatory documents.
Provide regular local status updates to SSU Project Lead; update appropriate study-tracking tools with local essential document and ethics committee status, and maintain project tracking systems for assigned projects.
Ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements.
Identify site issues during start-up process; resolve minor to moderate issues independently; escalate and participate in the resolution of complex issues.
The ideal candidate will need the following experience / skills to be considered:
Experience with EC submissions is required
Contract management experience will be an asset
Experience in the clinical research on the CRO preferred
Ability to be attentive to detail and place importance on accuracy of information
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Strong organizational skills
Ability to work independently in a fast-paced environment
Must demonstrate excellent computer skills
Fluency in German and English language
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.