Syneos Health

SSU Intern in Munich- Office-Based (6 months)

Munich (Stadt), Bayern (DE)
02 Feb 2021
04 Mar 2021
Full Time
Contract Type
Experience Level

Here at Syneos Health we are currently recruiting for a Study Start-Up Intern position to be based in Germany, this position can be filled in  Syneos Health office in Munich. 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:

- Liaise with study sites regarding essential document collection and assisting with IRB/EC submissions

- 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

- 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

- 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

- Support the development of start-up plans and essential document checklists

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

- University degree or equivalent education

- Ideally attended, or currently enrolled in, a further education program in Clinical Research

- Additionally, must meet eligibility requirements set forth in the Company’s Internship Program

- Proficient in Microsoft Office Suite

- Above average attention to detail, accuracy and organizational, interpersonal skills

- Ability to perform several tasks simultaneously to meet deadlines 

- Excellent verbal and written English and German communication skills