Study Start-Up & Regulatory Specialist II, Germany

Germany (DE)
Study Start-Up & Regulatory Specialist II, Germany
18 Sep 2019
18 Oct 2019
Full Time
Permanent
Experienced (non-manager)

Here at Syneos Health we are currently recruiting for a Study Start-Up  & Regulatory Specialist II to be based in Germany, this position may be offered home or office based. Within this role you’ll be responsible to cover submissions as well as contract / budget negotiations for your assigned studies across the DACH region. 

Job Details: 
- 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. 
- Support other departments as necessary 
- Identify site issues during start-up process; resolve minor to moderate issues independently; escalate and participate in the resolution of complex issues. 
- Mentor junior staff on local regulations and internal procedures. 
- Support the development of start-up plans and essential document checklists. 
- May play the role of Country Expert for internal intelligence collection and training purposes. 
- Lead a single-country/domestic study by providing work direction and oversight to a team. 
- Act as study start-up project lead on projects with limited scope establishing the CTA submission strategy (Regulatory Authorities and IRB/EC). 
- Act as Subject Matter Expert (SME) for a specific function of EDCS in a specific project or region 
- Complete assigned training programs and applying learning. 
- Complete necessary administrative tasks. 
- May perform other duties as assigned.

The ideal candidate will need the following experience / skills to be considered: 


- Clinical research/monitoring experience including several years study start-up experience 
- Ability to follow task-specific procedures, 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 effectively interact with project team(s) and effectively communicate in English and the local language of the country where located 
- Ability to work independently in a fast-paced environment with a sense of urgency to match the pace 
- Must demonstrate excellent computer skills 
- Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade 
- Occasional travel may be required