Study Start-Up & Regulatory Specialist II, Germany
- Experience Level
- 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.
- 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