Description

SSU & Regulatory Specialist, FSP

The role is fully home-based, with some very occasional travel to the Munich office every few months. In case you are Munich-based you will have the possibility to be in the office weekly. The position is full-time and permanent within Syneos Health, and set to support one big global pharma company. We have the flexibility to adjust the level of the role based on your experience in the SSU field.

The SSU & Regulatory Specialist is accountable for performance and compliance for assigned protocols in Germany in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of senior SSU & Regulatory Specialist or level above, you will be responsible for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

The responsibilities are:

Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. Development of local language materials including local language Informed Consents and translations. Interactions with IRB/IEC and Regulatory Authority for assigned protocols.

Responsible for managing country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country. Contributes to the development of local SOPs. Oversees Clinical Trial Assistants as applicable.

Coordinates and liaises with Project Management and Clinical Monitoring to ensure country deliverables are obtained for submissions and local milestones. Collaborates closely with Headquarter to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.

Oversight and coordination of local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical systems.

Has ownership, oversight and impact on local regulatory compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.

Works closely with the other departments to assess, prioritize and drive execution of specific clinical trials in order to support and manage the pipeline and local business needs to agreed timelines and budgets. Required to in/directly influence investigators, external partners and country operations to adhere to budget targets and agreed payment timelines.

Works in partnership internally with country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related-interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.

Qualifications

What we're looking for:

Min Bachelor´s Degree in Life Science/Administration or equivalent Health Care related experience, but MSc or PhD is preferred

Fluency in German and English

Min 5+ years experience in clinical research, some of which focused on SSU field

Skilled knowledge of local regulatory environment and submission and approval processes, and understanding of how these impact study start-up

Strong understanding of local regulatory environment for the individual to weigh pros and cons of key decisions with input from manager

Expertise of core clinical systems, tools and metrics

Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues

Ability to make decisions independently.

Problem solving is essential to this position. Requires the ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management for example quality and compliance issues, regulatory issues and issues related to functional area deliverables that could jeopardize protocol milestones.

Ability to focus on multiple deliverables and protocols simultaneously is essential. Requires that the individual has ability to work effectively also in a remote virtual environment with a wide range of people.

Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.

Additional Information:
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. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.