Site Activation Manager / Specialist Switzerland

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

For one of our single-sponsor partnerships we are currently looking for a Site Activation Manager or Specialist here in Switzerland.

This role is accountable for performance and compliance for assigned protocols in Switzerland in compliance with ICH/GCP and country regulations, sponsor policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure site readiness.

• Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
• Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems.
• Executes and oversees clinical trial country submissions and approvals for assigned protocols. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules, with moderate oversight.
• Develops local language materials including local language informed consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
• Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
• Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.

Qualifications

• Bachelor’s Degree
• 5-7 years of experience in Clinical Research and/or finance/business
• Detailed understanding of clinical trial process across Phases II-IV and ICH GCP.
• Ability to understand clinical protocols and associated study specifications.
• Detailed understanding of clinical trial start-up processes.
• Strong organizational skills with ability to handle multiple tasks effectively.
• Strong written and verbal communication and interpersonal skills.
• Fluency in both German and English
• Good negotiating skills and good problem-solving skills.
• Able to work from the office in Lucerne on a regular basis

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.

http://www.syneoshealth.com

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.