Syneos Health - Germany

Study Start Up Intern in Munich Germany

3 days left

Germany (DE)
04 Feb 2021
06 Mar 2021
Full Time
Contract Type
Experience Level
Entry 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     Disclaimer:  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.

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