Description
Clinical Operations Specialist/Project Specialist, sponsor dedicated, Switzerland

This role is based in Lucerne office with the option for home-office 2x per week. It is dedicated to a big global pharma company, and we offer a permanent, full-time, office-based contract. We also have the flexibility to adjust the level of the role to that of the successful candidate.

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Discover what our 29,000 employees, across 110 countries already know: Work here matters everywhere.

JOB SUMMARY

The position is responsible for providing clerical, technical and administrative support to one or more business units or clients within Clinical Operations. Provides overall study support to functional leads to ensure the successful completion of project deliverables. Mentors and/or trains less experienced staff.

JOB RESPONSIBILITIES

Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions

Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines

Creates and assists with maintenance of project files, handles project correspondence

Participates in file audits

Prepares and maintains site manuals, reference tools and other documents

Maintains, updates, and inputs clinical tracking information into databases

Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client

Manages shared mailbox, processes site requests and routes correspondence appropriately

Coordinates the ordering, packaging, shipping and tracking of site supplies and materials

Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items

Routinely anticipates, identifies and resolves potential issues and implements corrective actions, seeking guidance as needed to resolve more complex issues

Maintains overall awareness in the field of clinical research, as well as assigned areas, by completing all necessary and assigned training.

May provide training or mentorship to more junior level Clinical Operations Specialists (COS).

Qualifications

QUALIFICATION REQUIREMENTS

Min Bachelor's or MSc degree in Life Sciences (or equivalent combination of education, training and experience)

Fluent and English and German is mandatory. French or Italian at business fluent level is an advantage, but not required

Good knowledge of medical terminology, clinical data, and ICH/GCP is beneficial

Ability to successfully prioritize and work on multiple tasks

Strong attention to detail, accuracy and organizational skills

Excellent communication, presentation, and interpersonal skills

Ability to embrace new technologies

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

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.

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